A randomised controlled trial of senior Lay Health Mentoring in older people with ischaemic heart disease: The Braveheart Project. Behavior therapy for families of adolescents with diabetes: maintenance of treatment effects. Compliance therapy: a randomised controlled trial in schizophrenia. Pharmacist telemonitoring of antidepressant use: effects on pharmacist-patient collaboration. Do automated calls with nurse follow-up improve self-care and glycemic control among vulnerable patients with diabetes? Use of multisystemic therapy to improve regimen adherence among adolescents with type 1 diabetes in chronic poor metabolic control: a randomized controlled trial. Caring for poorly controlled diabetes mellitus: a randomized pharmacist intervention. Promoting adherence: effects of theory-based asthma education. A randomized trial of relapse prevention of depression in primary care. Nurse management for hypertension. A systems approach. Influence on asthma morbidity of asthma education programs based on self-management plans following treatment optimization. The role of the asthma nurse in treatment compliance and self-management following hospital admission. Improving adherence to malaria treatment for children: the use of pre-packed chloroquine tablets vs. chloroquine syrup. Compliance therapy in psychotic patients: randomised controlled trial. Randomised controlled trial of compliance therapy. 18-month follow-up. Self-recording of blood pressure in the management of hypertension. Effect of antidepressant drug counselling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial. How does patient education and self-management among asthmatics and patients with chronic obstructive pulmonary disease affect medication? Improvement of medication compliance in uncontrolled hypertension. [Efficacy of an intervention to improve treatment compliance in hyperlipidemias]. Efficacy of an educational and counseling intervention on adherence to highly active antiretroviral therapy: French prospective controlled study. Telephone follow-up of patients receiving antibiotic prescriptions from community pharmacies. Adherence to antiretroviral therapy in HIV-infected pediatric patients improves with home-based intensive nursing intervention. Effects of patient education on compliance with basic treatment regimens and health in recent onset active rheumatoid arthritis. Moderate dose, three-drug therapy with niacin, lovastatin, and colestipol to reduce low-density lipoprotein cholesterol <100 mg/dl in patients with hyperlipidemia and coronary artery disease. Randomised clinical trial of strategies for improving medication compliance in primary hypertension. Effectiveness of pharmacist care for patients with reactive airways disease: a randomized controlled trial. Effectiveness of the direct observation component of DOTS for tuberculosis: a randomised controlled trial in Pakistan. An intervention programme using the ASE-model aimed at enhancing adherence in adolescents with asthma. A comparison of enalapril 20 mg once daily versus 10 mg twice daily in terms of blood pressure lowering and patient compliance. Patient and relative education in community psychiatry: a randomized controlled trial regarding its effectiveness. A randomized study of serial telephone call support to increase adherence and thereby improve virologic outcome in persons initiating antiretroviral therapy. Prospective randomized two-Arm controlled study to determine the efficacy of a specific intervention to improve long-term adherence to highly active antiretroviral therapy. Asthma self-management: do patient education programs always have an impact? Efficacy of telephone and mail intervention in patient compliance with antihypertensive drugs in hypertension. ETECUM-HTA study. Efficacy of a home blood pressure monitoring programme on therapeutic compliance in hypertension: the EAPACUM-HTA study. Effect of counseling to improve compliance in Mexican women receiving depot-medroxyprogesterone acetate. Family-based intervention for schizophrenic patients in China. A randomised controlled trial. Evaluation of two different educational interventions for adult patients consulting with an acute asthma exacerbation. Pharmaceutical care of patients with heart failure. A randomized trial to improve self-management practices of adults with asthma. A randomized controlled evaluation of specialist nurse education following accident and emergency department attendance for acute asthma. Penicillin treatment of streptococcal pharyngitis. A comparison of schedules and the role of specific counseling. Group discussions with parents have long-term positive effects on the management of asthma with good cost-benefit. Couple-focused support to improve HIV medication adherence: a randomized controlled trial. The effect of ED prescription dispensing on patient compliance. A telecommunications system for monitoring and counseling patients with hypertension. Impact on medication adherence and blood pressure control. The role of patient training in the management of seasonal rhinitis and asthma: clinical implications. [Adherence to very active antiretroviral treatment: impact of individualized assessment]. A programmable prompting device improves adherence to highly active antiretroviral therapy in HIV-infected subjects with memory impairment. Effectiveness of psychoeducational intervention for rural Chinese families experiencing schizophrenia--a randomised controlled trial. A study of efficacy, tolerance and compliance of once-daily versus twice-daily metoprolol (Betaloc) in hypertension. Betaloc Compliance Canadian Cooperative Study Group. A cluster randomized trial comparing two interventions to improve treatment of major depression in primary care. Impact of an educational program on efficacy and adherence with a twice-daily lamivudine/zidovudine/abacavir regimen in underrepresented HIV-infected patients. Does patient education cause side effects? A controlled trial. A randomized trial of special packaging of antihypertensive medications. A randomised trial of strategies to improve patient compliance with anticonvulsant therapy. Impact of pharmacist-conducted home visits on the outcomes of lipid-lowering drug therapy. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. Management of Helicobacter pylori eradication--the influence of structured counselling and follow-up. A pharmacy discharge plan for hospitalized elderly patients--a randomized controlled trial. Education and telephone case management for children with type 1 diabetes: a randomized controlled trial. Informing patients about tardive dyskinesia. Controlled trial of patient education. Better maintained adherence on switching from twice-daily to once-daily therapy for HIV: a 24-week randomized trial of treatment simplification using stavudine prolonged-release capsules. Effects of a treatment adherence enhancement program on health literacy, patient-provider relationships, and adherence to HAART among low-income HIV-positive Spanish-speaking Latinos. Nurse-led adherence support in hypertension: a randomized controlled trial. Enhancing compliance not a prerequisite for effective eradication of Helicobacter pylori: the HelP Study. A randomized controlled trial to enhance antiretroviral therapy adherence in patients with a history of alcohol problems. Pharmaceutical care research and education project: patient outcomes. Helicobacter pylori eradication in dyspeptic primary care patients: a randomized controlled trial of a pharmacy intervention. Compliance and stability of INR of two oral anticoagulants with different half-lives: a randomised trial. Effect of individual cognitive behaviour intervention on adherence to antiretroviral therapy: prospective randomized trial. Effect of patient education on adherence to drug treatment for rheumatoid arthritis: a randomised controlled trial.
to examine the effects and feasibility of educating and empowering older people with ischaemic heart disease using trained senior lay health mentors.
                randomised controlled trial with blinded evaluation.
                Falkirk and District Royal Infirmary. Participants: inpatients and outpatients aged 60 or over attending secondary care with a diagnosis of angina or acute myocardial infarction. Three-hundred and nineteen entered and 289 completed exit assessments. The intervention group took part in mentoring groups for 1 year, meeting monthly for 2 hours, each led by two trained lay health mentors in addition to standard care.
                primary outcome measures were changes in coronary risk factors, medication usage and actual use of secondary care health services. Secondary outcomes were total and cardiovascular events; changes in medication compliance, non-medical support requirement, health status and psychological functioning, and social inclusion.
                there were significant improvements in a reported current exercise score (mean +0.33, +0.02 to +0.52), in the average time spent walking per week by 72 minutes (+1 to +137 minutes), and in the SF36 Physical Functioning Score (+6.1, +2.4 to +9.5). There was a 1.0% reduction in total fat (95% CI -3.0% to -0.6%) and a 0.6% reduction in saturated fat (95% CI -1.5% to -0.03%). The intervention group showed reduced outpatient attendance for coronary heart disease (-0.25 appointments, -0.61 to -0.08). Attendance rates were high. Socio-economic grouping did not affect participation.
                Lay Health Mentoring is feasible, practical and inclusive, positively influencing diet, physical activity, and health resource utilisation in older subjects with ischaemic heart disease without causing harm. This study reports 6- and 12-month follow-up for the families of adolescents with diabetes who participated in a trial of Behavioral-Family Systems Therapy (BFST).
                A total of 119 families of adolescents with type 1 diabetes were randomized to 3 months of treatment with either BFST, an education and support (ES) group, or current therapy (CT). Family relationships, adjustment to diabetes, treatment adherence, and diabetic control were assessed at baseline, after 3 months of treatment, and 6 and 12 months later. This report focuses on the latter two evaluations.
                Compared with CT and ES, BFST yielded lasting improvements in parent-adolescent relationships and diabetes-specific conflict. Delayed effects on treatment adherence emerged at 6- and 12-month follow-ups. There were no immediate or delayed effects on adolescents' adjustment to diabetes or diabetic control.
                BFST yielded lasting improvement in parent-adolescent relationships and delayed improvement in treatment adherence, but it had no effect on adjustment to diabetes or diabetic control. A variety of adaptations to BFST could enhance its impact on diabetes outcomes. To evaluate the efficacy of "compliance therapy" for improving adherence to prescribed drug treatment among patients with schizophrenia.
                Randomised controlled trial.
                Urban catchment area psychiatric service.
                94 consecutive admissions of patients with schizophrenia, 56 agreed to participate.
                Compliance therapy and non-specific counselling, each consisting of 5 sessions lasting 30-60 minutes.
                Compliance with drug treatment at one year; attitudes to treatment, symptomatology, insight, and quality of life at one year; length of "survival" in the community, bed days, and rehospitalisation rates at two years.
                Compliance therapy did not confer a major advantage over non-specific therapy in improving compliance at one year (43% (12/28) v 54% (15/28), difference -11% (95% confidence interval -37% to 15%) or in any of the secondary outcome measures-symptomatology, attitudes to treatment, insight, global assessment of functioning, and quality of life.
                Compliance therapy may not be of benefit to patients with schizophrenia. Attitudes to treatment at baseline predicted adherence one year later and may be a clinically useful tool. To explore the impact of telephone-based education and monitoring by community pharmacists on multiple outcomes of pharmacist-patient collaboration.
                A randomized, controlled, unblinded, mixed experimental design.
                Eight Wisconsin community pharmacies within a large managed care organization.
                A total of 63 patients presenting new antidepressant prescriptions to their community pharmacies.
                Patients were randomized to receive either three monthly telephone calls from pharmacists providing pharmacist-guided education and monitoring (PGEM) or usual pharmacist's care. Usual care is defined as that education and monitoring which pharmacists may typically provide patients at the study pharmacies.
                Patient's frequency of feedback with the pharmacist, antidepressant knowledge, antidepressant beliefs, antidepressant adherence at 3 and 6 months, improvement in depression symptoms, and orientation toward treatment progress.
                Of the 60 patients who completed the study, 28 received PGEM and 32 received usual pharmacist's care. Results showed that PGEM had a significant and positive effect on patient feedback, knowledge, medication beliefs, and perceptions of progress. There were no significant group differences in patient adherence or symptoms at 3 months; however, PGEM patients who completed the protocol missed fewer doses than did the usual care group at 6 months (P < or = .05).
                Antidepressant telemonitoring by community pharmacists can significantly and positively affect patient feedback and collaboration with pharmacists. Longer-term studies with larger samples are needed to assess the generalizability of findings. Future research also needs to explore additional ways to improve clinical outcomes. We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes.
                We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system. Patients were randomly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator. Outcomes measured at 12 months included survey-reported self-care, perceived glycemic control, and symptoms, as well as glycosylated hemoglobin (Hb A1c) and serum glucose levels.
                We collected follow-up data for 89% of enrollees (248 patients). Compared with usual care patients, intervention patients reported more frequent glucose monitoring, foot inspection, and weight monitoring, and fewer problems with medication adherence (all P -0.03). Follow-up Hb A,, levels were 0.3% lower in the intervention group (P = 0.1), and about twice as many intervention patients had Hb A1c levels within the normal range (P = 0.04). Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients (P = 0.002). Intervention patients also reported better glycemic control (P = 0.005) and fewer diabetic symptoms (P <0.0001 ), including fewer symptoms of hyperglycemia and hypoglycemia.
                Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control, and for decreasing symptoms among vulnerable patients with diabetes. The aim of this study was to determine whether multisystemic therapy (MST), an intensive, home-based psychotherapy, could improve adherence and metabolic control and decrease rates of hospital utilization among adolescents with chronically poorly controlled type 1 diabetes.
                A randomized controlled trial was conducted with 127 adolescents with type 1 diabetes and chronically poor metabolic control (HbA(1c) [A1C] > or =8% for the past year) who received their diabetes care in a children's hospital located in a major Midwestern city. Participants randomly assigned to MST received treatment for approximately 6 months. Data were collected at baseline and at 7 months posttest (i.e., treatment termination). Changes in A1C adherence, as measured by semistructured interviews and blood glucose meters and hospital admissions and emergency department visits, were assessed.
                In intent-to-treat analyses, participation in MST was associated with significant improvements in the frequency of blood glucose testing as assessed by blood glucose meter readings (F[1,125] = 16.75, P = 0.001) and 24-h recall interviews (F[1,125] = 6.70, P = 0.011). Participants in MST also had a decreasing number of inpatient admissions, whereas the number of inpatient admissions increased for control subjects (F[1,125] = 6.25, P = 0.014). Per protocol analyses replicated intent-to-treat analyses but also showed a significant improvement in metabolic control for adolescents receiving MST compared with control subjects (F[1,114] = 4.03, P = 0.047).
                Intensive, home-based psychotherapy improves the frequency of blood glucose testing and metabolic control and decreases inpatient admissions among adolescents with chronically poorly controlled type 1 diabetes. There is limited information from randomized controlled studies about the influence of pharmacist interventions on diabetes control.
                To evaluate the effect of a pharmacist intervention on improving diabetes control; secondary endpoints were medication appropriateness and self-reported adherence.
                A randomized, controlled, multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics. Seventy-seven subjects, > or =18 years old with a hemoglobin (Hb) A(1c) > or =9% at baseline and taking at least one oral diabetes medication, were randomized to receive a pharmacist intervention (n = 43) or usual care (n = 34) for 6 months followed by a 6-month usual-care observation period for both groups. Subjects met with a clinical pharmacist to establish and initiate a diabetes care plan followed by weekly visits or telephone calls to facilitate diabetes management and adherence. HbA(1c), medication appropriateness, and self-reported adherence were assessed at baseline, 6 months, and 12 months.
                The mean HbA(1c) did not differ between groups over the 12-month period (p = 0.61). A reduction in HbA(1c) was noted for both groups over time compared with baseline (p = 0.001); however, control subjects relied more heavily on provider visits. Medication appropriateness was not improved for diabetes medications (p = 0.65). Self-reported adherence was not significantly improved by the intervention.
                This pharmacist intervention did not significantly improve diabetes control, but did allow for similar HbA(1c) control with fewer physician visits. Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed. This study compared the effects of a theoretically focused audiotape and a standard educational booklet on asthma preventive medication adherence and other asthma outcomes. Forty-six adult asthmatics were randomly assigned to receive either an experimental audiotape incorporating components of protection motivation theory, a standard asthma management booklet, both, or no educational materials. Outcomes were assessed at baseline, 3 months, and 6 months. Mean pharmacy-verified adherence improved 15% to 19% in the intervention groups and declined 22% in the control group at 6 months. Using analysis of covariance (ANCOVA) to control for baseline adherence, these changes were significant between the control and booklet group (t = 2.47; p = .02) and between control and combined group (t = 2.07; p = .04). Providing a minimal educational intervention can have a beneficial effect on asthma medication adherence that persists at least 6 months. Despite high rates of relapse and recurrence, few primary care patients with recurrent or chronic depression are receiving continuation and maintenance-phase treatment. We hypothesized that a relapse prevention intervention would improve adherence to antidepressant medication and improve depression outcomes in high-risk patients compared with usual primary care.
                Three hundred eighty-six patients with recurrent major depression or dysthymia who had largely recovered after 8 weeks of antidepressant treatment by their primary care physicians were randomized to a relapse prevention program (n = 194) or usual primary care (n = 192). Patients in the intervention group received 2 primary care visits with a depression specialist and 3 telephone visits over a 1-year period aimed at enhancing adherence to antidepressant medication, recognition of prodromal symptoms, monitoring of symptoms, and development of a written relapse prevention plan. Follow-up assessments were completed at 3, 6, 9, and 12 months by a telephone survey team blinded to randomization status.
                Those in the intervention group had significantly greater adherence to adequate dosage of antidepressant medication for 90 days or more within the first and second 6-month periods and were significantly more likely to refill medication prescriptions during the 12-month follow-up compared with usual care controls. Intervention patients had significantly fewer depressive symptoms, but not fewer episodes of relapse/recurrence over the 12-month follow-up period.
                A relapse prevention program targeted to primary care patients with a high risk of relapse/recurrence who had largely recovered after antidepressant treatment significantly improved antidepressant adherence and depressive symptom outcomes. Standard office-based approaches to controlling hypertension show limited success. Such suboptimal hypertension control reflects in part the absence of both an infrastructure for patient education and frequent, regular blood pressure (BP) monitoring. We tested the efficacy of a physician-directed, nurse-managed, home-based system for hypertension management with standardized algorithms to modulate drug therapy, based on patients' reports of home BP.
                We randomized outpatients requiring drug therapy for hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) criteria to receive usual medical care only (UC, n = 76) or usual care plus nurse care management intervention (INT, n = 74) over a 6-month period.
                Patients receiving INT achieved greater reductions in office BP values at 6 months than those receiving UC: 14.2 +/- 18.1 versus 5.7 +/- 18.7 mm Hg systolic (P < .01) and 6.5 +/- 10.0 versus 3.4 +/- 7.9 mm Hg diastolic, respectively (P < .05). At 6 months, we observed one or more changes in drug therapy in 97% of INT patients versus 43% of UC patients, and 70% of INT patients received two or more drugs versus 46% of UC. Average daily adherence to medication, measured by electronic drug event monitors, was superior among INT subjects (mean +/- SD, 80.5% +/- 23.0%) than among UC subjects (69.2 +/- 31.1%; t(113) = 2.199, P = .03). There were no significant adverse drug reactions in either group.
                Telephone-mediated nurse management can successfully address many of the systems-related and patient-related issues that limit pharmacotherapeutic effectiveness for hypertension. The objective of this study was to evaluate the effectiveness of an asthma education program on morbidity, knowledge, and compliance with inhaled corticosteroid treatment using a prospective, randomized, controlled, one-year-before/one-year-after protocol. After rigorous optimization of asthma therapy under the care of respirologists, patients were assigned to one of three groups: Group C (control group: no formal education), Group P (education and action plan based on peak-flow monitoring), and Group S (education with action plan based on monitoring of asthma symptoms). A total of 188 subjects with moderate to severe asthma were enrolled and 149 completed the study. Asthma morbidity decreased significantly in all groups (p = 0.001). Mean values one-year-before/one-year-after in Groups C, P, and S were: unscheduled medical visits, 2.4/0.8, 2.3/0.7, and 1.9/ 0.7; hospitalizations, 0.21/0.04, 0.24/0.04, and 0.40/0.09; oral steroid treatments; 1.3/0.5, 1.2/0.7, and 1.3/0.9; absenteeism from work/school, 9.6/5.2, 8.8/2.2, and 6.3/2.9. Between-group differences did not reach statistical significance (p > 0.05). Asthma knowledge increased in both educated groups compared with the control group (p < 0.001) as did short-term compliance with inhaled corticosteroids. These results confirm that treatment optimization coupled with sustained high quality care in motivated patients can lead to a significant decrease in asthma morbidity. In such clinical settings, structured asthma education significantly improved short-term compliance with treatment and knowledge about asthma, although it could not add extra benefit with regard to morbidity. Nevertheless, this study does not refute the potential benefit of educational interventions aimed at improving asthma-related morbidity over a longer time period or in patients with less optimal care or with high-risk factors. Effective self-management and treatment compliance is important in achieving good symptom control in asthma. The aim of this study was to determine whether asthma nurse intervention during hospital admission could increase knowledge and improve self-management and whether this would influence the number of emergency call-out visits by Genera Practitioners (GPs) and hospital re-admissions. Patients with acute asthma (n=80) were assessed by the asthma nurse within 24 h of admission using a British Thoracic Society (BTS) guideline-based questionnaire. Main outcome measures were: know edge of inhalers, self-management plans, peak flow monitoring, recognition of worsening symptoms and appropriate emergency action, Following randomization, half received nurse intervention during hospitalization. All received a follow-up questionnaire 6 weeks post-discharge and again at 6 months (response rates 86% and 81% respectively). GPs were contacted by postal questionnaire after 4 months. Questionnaire responses indicated an increase in knowledge in the intervention group, along with an ability to identify appropriate action on worsening symptoms. Emergency GP call-outs were more frequent in the control group in the 4 months post-discharge. Hospital re-admission rates were similar in both groups. Asthma nurse intervention appeared to increase knowledge of asthma management, maintained throughout the study period, but had no significant impact on reducing re-admissions to hospital. Malaria is a major cause of morbidity and mortality among children under five in sub-Saharan Africa. Prompt diagnosis and adequate treatment of acute clinical episodes are essential to reduce morbidity and prevent complications and mortality. In many countries, chloroquine syrup is the mainstay of malaria treatment for children under five. Not only is syrup more expensive than tablets, adherence to the prescribed dose at home is a problem because mothers use wrongly sized measuring devices or have difficulty with the instructions. We investigated the impact of introducing pre-packed tablets for children on adherence to treatment and compared the total cost of the tablets with that of syrup. Children aged 0--5 years diagnosed with malaria at the clinic over a 6-week period received either pre-packed tablets or syrup by random assignment. The principal caregivers were interviewed at home on day 4 after attending the clinic. Of the 155 caregivers given pre-packed tablets, 91% (n=141) adhered to the recommended dosage, while only 42% (n=61) of 144 who were provided syrup did. Only 20% of caregivers who received syrup used an accurate 5 ml measure. The cost of treatment with tablets was about one-quarter that of syrup and 62% (n=96) of caregivers preferred tablets. Pre-packed chloroquine tablets are a viable alternative to syrup. To determine whether compliance therapy, a cognitive-behavioural intervention, could improve compliance with treatment and hence social adjustment in acutely psychotic inpatients, and if so, whether the effect persisted six months later.
                Randomised controlled trial of compliance therapy and non-specific counselling, each comprising 4-6 sessions lasting 10-60 minutes.
                Acute psychiatric admissions ward serving an inner London catchment area.
                47 patients with psychosis.
                Informant and observer reported measure of compliance; observer assessed global functioning after intervention and three and six months later; self-rated attitudes to drug treatment after the intervention and one month later; symptom scores after intervention and six months later.
                25 patients received compliance therapy and showed significantly greater improvements in their attitudes to drug treatment and in their insight into illness and compliance with treatment compared with the control group. These gains persisted for six months. The intervention group was 5.2 times more likely than the control group to reach a criterion level of compliance (95% confidence interval 1.5 to 18.3). Global functioning showed a tendency to improve more in the intervention group after a delay (odds ratio 3.0 (0.8 to 11.5) to reach the criterion level at six months). Four subjects given compliance therapy and six in the control group were readmitted during follow up (odds ratio 2.0 (0.48 to 8.2)).
                Compliance therapy is a pragmatic method for improving compliance with drug treatment in psychotic inpatients and its gains persist for at least six months. Overall functioning may also be enhanced. A randomised controlled trial was conducted in an acute treatment setting to examine the effectiveness of compliance therapy, a brief pragmatic intervention targeting treatment adherence in psychotic disorders, based on motivational interviewing and recent cognitive approaches to psychosis.
                Seventy-four patients with psychotic disorders according to DSM-III-R criteria recruited from consecutive admissions to an acute in-patient unit, received 4-6 sessions of either compliance therapy or non-specific counselling, and were followed-up over 18 months. The principal outcome measures were observer-rated compliance, attitudes to treatment, insight and social functioning.
                Significant advantages were found for the compliance therapy group post-treatment on measures of insight, attitudes to treatment and observer-rated compliance which were retained over the follow-up period. Global social functioning improved relatively more over time in the compliance therapy group compared with the control group. Survival in the community prior to readmission was significantly longer in the compliance therapy group.
                The results support the effectiveness of compliance therapy in improving functioning and community tenure after an acute psychotic episode. The efficacy of self-recording of blood pressure in the management of hypertension was assessed in a randomized clinical trial involving 140 persons who had been receiving antihypertensive therapy for a year or more, but whose diastolic blood pressure had remained at 95 mm Hg or higher. To control for the increased attention implicit in self-recording, which might affect blood pressure, the patients were assigned at random to one of the four groups: self-recording and monthly home visits, self-recording only, monthly home visits only, and neither self-recording nor monthly home visits. This design also permitted assessment of the effect of home visits. During the 6-month experiment no significant differences were apparent between the groups in either compliance or diastolic blood pressure. However, both self-recording and monthly home visits produced a reduction in blood pressure among patients who admitted to difficulty remembering to take their pills; a reduction was not seen among patients who said they had no such difficulty. This confirmed an earlier observation suggesting that this easily identified group of patients may be the most responsive to intervention programs. To evaluate two different methods of improving adherence to antidepressant drugs.
                Factorial randomised controlled single blind trial of treatment leaflet, drug counselling, both, or treatment as usual.
                Primary care in Wessex
                250 patients starting treatment with tricyclic antidepressants.
                Adherence to drug treatment (by confidential self report and electronic monitor); depressive symptoms and health status.
                66 (63%) patients continued with drugs to 12 weeks in the counselled group compared with 42 (39%) of those who did not receiving counselling (odds ratio 2.7, 95% confidence interval 1.6 to 4.8; number needed to treat=4). Treatment leaflets had no significant effect on adherence. No differences in depressive symptoms were found between treatment groups overall, although a significant improvement was found in patients with major depressive disorder receiving drug doses of at least 75 mg (depression score 4 (SD 3.7) counselling v 5.9 (SD 5.0) no counselling, P=0.038).
                Counselling about drug treatment significantly improved adherence, but clinical benefit was seen only in patients with major depressive disorder receiving doses >/=75 mg. Further research is required to evaluate the effect of this approach in combination with appropriate targeting of treatment and advice about dosage. The effect of patient education on steroid inhaler compliance and rescue medication utilization in patients with asthma or chronic obstructive pulmonary disease (COPD) has not been previously investigated in a single study. We randomized 78 asthmatics and 62 patients with COPD after ordinary outpatient management. Intervention consisted of two 2-h group sessions and 1 to 2 individual sessions by a trained nurse and physiotherapist. A self-management plan was developed. We registered for 12 mo medication dispensed from pharmacies according to the Anatomical Therapeutic Chemical (ATC) classification index. Steroid inhaler compliance (SIC) was defined as (dispensed/prescribed) x 100 and being compliant as SIC > 75%. Among asthmatics 32% and 57% were compliant (p = 0.04) with a median (25th/75th percentiles) SIC of 55% (27/96) and 82% (44/127) (p = 0.08) in the control and intervention groups, respectively. Patient education did not seem to change SIC in the COPD group. Uneducated patients with COPD were dispensed double the amount of short-acting inhaled beta(2)-agonists compared with the educated group (p = 0.03). We conclude that patient education can change medication habits by reducing the amount of short-acting inhaled beta(2)-agonists being dispensed among patients with COPD. Educated asthmatics showed improved steroid inhaler compliance compared with the uneducated patients, whereas this seemed unaffected by education in the COPD group. 38 hypertensive Canadian steelworkers who were neither compliant with medications nor at goal diastolic blood-pressure six months after starting treatment were allocated either to a control group or to an experimental group who were taught how to measure their own blood-pressures, asked to chart their home blood-pressures and pill taking, and taught how to tailor pill taking to their daily habits and rituals; these men were also seen fortnightly by a highschool graduate with no formal health professional training who reinforced the experimental manoeuvres and rewarded improvements in compliance and blood-pressure. Six months later, average compliance had fallen by 1.5% in the control group but rose 21.3% in the experimental group. Blood-pressures fell in 17 of 20 experimental patients (to goal in 6) and in 10 of 18 control patients (to goal in 2). To analyse the efficacy of the intervention through a telephone call about patients' compliance with lipaemia therapy.
                Controlled, randomised clinical trial.
                Ten clinics at 6 primary care centres.
                126 people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen.
                Two groups were formed. The control group (CG) of 63 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 63 patients, who received in addition a telephone call at 2 weeks, 2 months and 4 months.
                Pills were counted and cholesterol, triglycerides, HDL-C and LDL-C determined at the start, and at the third and sixth months. Percentages of patients complying (80%-110%), the mean compliance percentage and the degree of control were compared. The reduction of absolute and relative risk (RAR and RRR) and the mean number of people that required an intervention in order to avoid non-compliance (NI) were calculated.
                115 people (91.26%) completed the survey, 56 in the IG and 59 in the CG. 77.1% complied with the therapy (CI, 68.4-85.8), (CG=64.4%, CI, 55.3-73.5; IG=93.5%, CI, 88.8-98 [P<.001]). Mean compliance ran at 88.7 +/- 10.2 overall, at 84.4 +/- 12.8 in the CG and at 93 +/- 8.2 in the IG (P<.001). The RAR was 29.1%, the RRR 81%, and the NI was 3.43 patients. The patients controlled ran at 43.9% in the IG (CI, 34.9-52.9) and 23.1% in the CG (CI, 15.4-30.8) (P<.005).
                The telephone intervention is an efficacious way of improving the percentage of patients complying with lipaemia treatment. The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients.
                We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At M0, the study enrolled 244 HAART-treated patients who attended a medical consultation between September and December 1999 who were not included in another protocol. Patients in the intervention group (IG) were offered three individual sessions by trained nurses. The proportions of adherent patients at 6 months followup (M6) and the change in HIV RNA between M0 and M6 were measured.
                Between M0 and M6, HIV RNA significantly decreased in the 123 patients of the IG (mean difference = -0.22 log [+/-0.86], p =.013), while it increased (+0.12 log [+/-0.90], p =.14) in the 121 patients of the control group. However, the proportion of patients with HIV RNA <40 copies/mL remained similar in both groups. In an intent-to-treat analysis, the only significant predictor of 100% adherence at M6 was the intervention group (p =.05) after adjustment for baseline adherence (p =.001). Among the 202 patients with available data on adherence, the proportion of adherent patients was similar in both groups at M0 (58% vs. 63%, p =.59) but became higher in the IG at M6 (75% vs. 61%, p =.04).
                The educational and counseling intervention was efficient for increasing adherence to HAART and could be implemented in most clinical settings. The impact of a community pharmacist telephone follow-up intervention (PTFI) on clinical outcomes, pharmaceutical care, and costs for patients undergoing antibiotic treatment was studied.
                Patients receiving usual pharmacist intervention (UPI) were compared with PTFI patients in a multicenter, randomized, controlled trial.
                Compared with the UPI group (n = 129), the PTFI group (n = 126) had more drug-related problems (DRPs) (PTFI = 53%, UPI = 8%; p < 0.001). Oral recommendations (PTFI = 52%, UPI = 6%; p < 0.001), as well as recognized (PTFI = 10%, UPI = 2%; p = 0.015) and study-specific (PTFI = 5%, UPI = 1%; p = 0.064) pharmaceutical advices, were issued for more patients. The mean difference in the change in the number of infectious symptoms between the two groups (-0.24 symptom, 95% confidence interval [CI] = -1.22 to 0.74) and the change in the infection severity score (mean difference = -0.05 unit, 95% CI = -0.35 to 0.25) were small and not statistically significant. Adherence to treatment and patient satisfaction did not differ across the two intervention groups. The incremental direct costs of the PTFI varied from $2.65 to $5.11 (Canadian dollars) per patient, depending on whether cognitive services were reimbursed.
                A telephone follow-up by community pharmacists during antibiotic therapy was simple and quick and created opportunities to intervene with patients, but it did not create a greater change in the number of infectious symptoms or the infection severity score than did usual care. Adherence to combination antiretroviral therapy (ART) has been shown to be a determining factor in controlling viral replication, maintaining immunologic function and long-term survival in HIV-positive individuals. Little information is available on strategies to improve adherence in pediatric HIV-infected patients. We conducted a randomized, nonblinded, pilot study to determine if a home-based nursing intervention would improve medication adherence. The study was offered to all eligible HIV-positive patients receiving care at Connecticut Children's Medical Center's (CCMC) Pediatric and Youth HIV Program. Sixty-seven percent (37/55) of the patients and their caretakers participated. We randomized participants to either standard of care or the intervention trial. The intervention was designed to improve knowledge and understanding of HIV infection and HIV medications and to resolve or modify barriers to adherence. Both groups completed pre- and post-intervention questionnaires, assessing their knowledge and understanding of HIV, ART, and adherence. Adherence was estimated objectively from medication refill history and subjectively from a self-report score. We also inferred adherence from pre- to post-test plasma viral load and CD4+ T-cell percentages. The knowledge score (p = 0.02) and medication refill history (p = 0.002) improved significantly in the intervention group. The adherence self-report score improved, although not significantly (p = 0.07). We did not observe statistical differences in CD4+ T-cell counts or viral load between groups. We conclude that our home-based nursing intervention helped HIV-positive children and their families in better adhering to prescribed medication regimens. To determine the effects of patient education on compliance and on health in patients with active, recent onset rheumatoid arthritis (RA).
                A randomised, controlled, assessor blinded, one year trial. The experimental group followed an education programme. All patients started on sulphasalazine therapy. Compliance with sulphasalazine was measured by pill counting. Compliance rates with regimens of physical exercise, endurance activities, and energy conservation were measured by questionnaires. Compliance with prescriptions of joint protection was scored using a test for joint protection performance. Health was measured by a Disease Activity Score (function of erythrocyte sedimentation rate, Ritchie score, and number of swollen joints), C reactive protein, Dutch-AIMS scores, and M-HAQ scores, range of motion of shoulder, elbow, and knee joints. Parameters were scored at baseline and after three, six, and 12 months.
                Sixty of 65 patients gave informed consent, five of them withdrew from follow up. Compliance with sulphasalazine exceeded 80% with no differences between groups. Compliance with physical exercise (at three months), energy conservation (at three and at 12 months), and joint protection (at three months) improved significantly more in the experimental group. The improvements of health were not different in the groups.
                Compliance with sulphasalazine among patients with active, recent onset RA is high, whether formal patient education is followed or not. Compliance with physical exercise, energy conservation, and joint protection was increased by patient education. Formal patient education did not improve health status. The efficacy, safety, and tolerability of a moderate dose, 3-drug lipid-lowering regimen were evaluated among 29 male patients with hyperlipidemia and coronary artery disease. In an initial 12-month phase, regular niacin, 500 mg qid, lovastatin, 20 mg bid, and colestipol, 10 g/bid, were given with dose adjustment for lipid targets and side effects. This was followed by 2 random sequence crossover phases (8 months each) alternating regular niacin with a polygel controlled-release formulation of niacin for use in this regimen. Lipid, lipoprotein, apoprotein, and clinical chemistry determinations were obtained at baseline, during the initial phase, at the 2 crossover phases, and at 6 weeks after therapy. A final questionnaire queried specific side effects and overall preferences. Low-/high-density lipoprotein (LDL/HDL) changed from means of 215/46 mg/dl at baseline, to 94/59 mg/dl after run-in, to 85/52 mg/dl after 8 months of controlled-release niacin, and to 98/56 mg/dl after 8 months of regular niacin (regular niacin vs controlled-release niacin, p <0.005/<0.05). The target of LDL < or = 100 mg/dl was achieved at 8 months by 83% of these patients with controlled-release niacin and by 52% with regular niacin (p <0.01). Compliance was 95% with controlled-release niacin versus 85% with regular niacin (p <0.001). The controlled-release niacin and regular niacin regimens did not differ in terms of uric acid, glucose, insulin, or asparate aminotransferase levels. Overall, 21% of patients called the 3 drugs "very easy" and 72% "fairly easy" to take. The controlled-release niacin-containing regimen was preferred by 21 patients and the regular niacin by 4. In conclusion, these regimens achieve striking lipid changes among hyperlipidemic patients. Controlled release is the preferred niacin preparation in terms of LDL reduction, compliance, patient preference, and achieving the National Cholesterol Education Program guideline of LDL < or = 100 mg/dl. The 2 niacin preparations did not differ in evidence of toxicity. 230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine. It is not known whether patient outcomes are enhanced by effective pharmacist-patient interactions.
                To assess the effectiveness of a pharmaceutical care program for patients with asthma or chronic obstructive pulmonary disease (COPD).
                Randomized controlled trial conducted at 36 community drugstores in Indianapolis, Ind. We enrolled 1113 participants with active COPD or asthma from July 1998 to December 1999. Outcomes were assessed in 947 (85.1%) participants at 6 months and 898 (80.7%) at 12 months.
                The pharmaceutical care program (n = 447) provided pharmacists with recent patient-specific clinical data (peak expiratory flow rates [PEFRs], emergency department [ED] visits, hospitalizations, and medication compliance), training, customized patient educational materials, and resources to facilitate program implementation. The PEFR monitoring control group (n = 363) received a peak flow meter, instructions about its use, and monthly calls to elicit PEFRs. However, PEFR data were not provided to the pharmacist. Patients in the usual care group (n = 303) received neither peak flow meters nor instructions in their use; during monthly telephone interviews, PEFR rates were not elicited. Pharmacists in both control groups had a training session but received no components of the pharmaceutical care intervention.
                Peak expiratory flow rates, breathing-related ED or hospital visits, health-related quality of life (HRQOL), medication compliance, and patient satisfaction.
                At 12 months, patients receiving pharmaceutical care had significantly higher peak flow rates than the usual care group (P =.02) but not than PEFR monitoring controls (P =.28). There were no significant between-group differences in medication compliance or HRQOL. Asthma patients receiving pharmaceutical care had significantly more breathing-related ED or hospital visits than the usual care group (odds ratio, 2.16; 95% confidence interval, 1.76-2.63; P<.001). Patients receiving pharmaceutical care were more satisfied with their pharmacist than the usual care group (P =.03) and the PEFR monitoring group (P =.001) and were more satisfied with their health care than the usual care group at 6 months only (P =.01). Despite ample opportunities to implement the program, pharmacists accessed patient-specific data only about half of the time and documented actions about half of the time that records were accessed.
                This pharmaceutical care program increased patients' PEFRs compared with usual care but provided little benefit compared with peak flow monitoring alone. Pharmaceutical care increased patient satisfaction but also increased the amount of breathing-related medical care sought. DOTS is the control strategy for tuberculosis promoted by WHO. Pakistan is currently developing its National Tuberculosis Programme, and requires guidance on types of direct observation of treatment appropriate for the local conditions. We did a randomised trial to assess the effectiveness of different packages for tuberculosis treatment under operational conditions in Pakistan.
                We enrolled 497 adults with new sputum-positive tuberculosis. 170 were assigned DOTS with direct observation of treatment by health workers; 165 were assigned DOTS with direct observation of treatment by family members; and 162 were assigned self-administered treatment. The trial was done at three sites that provide tuberculosis services strengthened according to WHO guidelines for the purposes of the research, with a standard daily short-course drugs regimen (2 months of isoniazid, rifampicin, pyrazinamide, and ethambutol, followed by 6 months of isoniazid and ethambutol). The main outcome measures were cure, and cure or treatment completion. Analysis was by intention to treat.
                Within the strengthened tuberculosis services, the health-worker DOTS, family-member DOTS, and self-administered treatment strategies gave very similar outcomes, with cure rates of 64%, 55%, and 62%, respectively, and cure or treatment-completed rates of 67%, 62%, and 65%, respectively.
                None of the three strategies tested was shown to be superior to the others, and direct observation of treatment did not give any additional improvement in cure rates. The effectiveness of direct observation of treatment remains unclear, and further operational research is needed. A randomised controlled trial, involving 112 adolescents with asthma, and a 2-year follow-up was conducted to assess the impact of an intervention programme aimed at enhancing adherence to asthma medication. This programme had a duration of 1 year and consisted of an experimental group which received usual care from a paediatrician, but additionally attended individual and group sessions with an asthma nurse, and a control group which received usual care only. The programme aimed at enhancing adherence by stimulating a positive attitude, increasing feelings of social support, and enhancing self-efficacy. At baseline, and after 12-month (T1) and 24-month (T2) follow-up, the participants filled in questionnaires which were based on the concepts of the ASE-model. Adherence was assessed by self-report (range: 1-10) at the same points in time. After 12 months, 97 adolescents (87%) were available for follow-up, decreasing to 86 adolescents (77%) after 24 months. No statistically significant differences were found between the control and the experimental group, except for one. At T2, self-reported adherence appeared to be statistically significantly higher in the experimental group. In conclusion, there seems to have been no substantial effect of the intervention programme. To compare enalapril 20 mg once daily with 10 mg twice daily in terms of blood pressure reduction and patient compliance.
                Cross-over study of patients randomly assigned to a sequence of enalapril 20 mg once daily or 10 mg twice daily in three 4-week periods following a 4-week placebo run-in.
                General practices in the greater Belfast and Lisburn area in Northern Ireland.
                Twenty-five hypertensive patients who had a mean diastolic blood pressure of between 90 and 110 mm Hg after receiving placebo for 4 weeks.
                Reduction in blood pressure and estimation of patient compliance.
                Patient compliance was superior on the once daily regimen. However, the twice daily regimen was associated with a greater blood pressure reduction which almost reached statistical significance at the 5% level.
                Enalapril 20 mg should be prescribed as 10 mg twice daily and measures taken to improve patient compliance. Family psychoeducation has a well-documented effect on the short-term prognosis in schizophrenia. Less is known about the effectiveness of shorter programmes with the main focus on information for patients (patient education) or for patients and relatives (family education).
                A randomized study of the effectiveness of an eight-session psychoeducational programme for patients with schizophrenia and for their relatives was conducted in two community mental health centres, in Arhus and Viborg (Denmark). Patient outcome measures were knowledge, relapse, compliance, insight and satisfaction, and relative outcome measures were knowledge and satisfaction. Post-intervention outcome and follow-up evaluation 1 year after the start of the intervention are presented.
                A statistically significant increase in knowledge of schizophrenia in both relatives and patients was demonstrated at postintervention and a non-significant trend at 1-year follow-up. Statistically significant changes in the Verona Service Satisfaction Scale Scores in the subdimension of satisfaction with Relatives involvement were demonstrated both for patients and relatives postintervention and for patients at 1-year follow-up. There was a tendency that time-to-relapse increased in the intervention group at postintervention and that the schizophrenia subscore of the Brief Psychiatric Rating Scale was reduced in the intervention group at 1-year follow-up. No differences were found between the groups regarding compliance, insight into psychosis, psychosocial function (General Assessment of Function) or in relatives' expressed emotion scores postintervention or at 1-year follow-up.
                A short patient and relative education programme seems to be able to influence knowledge and some aspects of satisfaction, but does not seem to be sufficient to influence important variables such as relapse, compliance, psychopathology, insight or psychosocial functioning. Adherence to antiretroviral therapy is difficult, and methods to increase it are needed.
                We tested the impact of supportive telephone calls in an adherence substudy of a treatment trial. Subjects initiating antiretroviral therapy received either each site's usual adherence support measures or usual support measures and scripted serial telephone calls (16 calls during 96 weeks).
                A total of 282 subjects enrolled: 140 in the usual support measures group and 142 in the calls group. A total of 75% of expected calls were completed. Virologic failure occurred in 97 (34%) subjects: 52 (37%) of those in the usual support measures group and 45 (32%) of those in the calls group; time to virologic failure was not different (P=.32). In each group, >72% of subjects reported > or =95% adherence, with no difference between groups. Independent predictors of higher rates of virologic failure were <95% adherence, receiving the 4-drug regimen with nelfinavir, and female sex; older age was associated with decreased likelihood of virologic failure. Receiving the 4-drug regimen with nelfinavir, higher stress scores, older age, and higher call completion rates were independently associated with higher adherence.
                Serial telephone calls did not improve virologic outcome but had an impact on self-reported adherence. Nearly perfect compliance seems to be indispensable to obtain the maximum benefit from highly active antiretroviral therapy (HAART). Interventions to ensure a high level of adherence during a relatively long-term period of therapy are necessary.
                This is a prospective, randomized, two-arm controlled study including patients starting their first-or second-line HAART who were randomized to receive psychoeducative intervention to implement adherence (experimental group [EG]) or a usual medical follow-up (control group [CG]). We aimed to study the efficacy of a psychoeducative intervention to ensure long-term adherence to HAART, its relation with the virologic efficacy of treatment, and to determine the variables related to long-term adherence. Visits were made at weeks 0, 4, 24, and 48 for data collection. Self-reported adherence was registered at each visit and its veracity was tested by randomized blood analyses performed without previous warning to 40% of patients. Appropriate adherence was defined as the consumption of >/=95% of medication prescribed. Statistical analyses were performed both by the as treated (AT) and the intention to treat missing = failure (ITT) methods.
                In all, 116 patients were included. At week 48, 94% of patients in the EG versus 69% controls achieved adherence >/=95% (p =.008); 89% of patients in the EG versus 66% controls had HIV-1 RNA levels <400 copies/ml (p =.026). Overall, 85% of patients with adherence >/=95% but only 45% of those with adherence <95% had viral load (VL) <400 copies/ml (p =. 008). In multivariate analysis, variables significantly related to adherence were having received a psychoeducative intervention (odds ratio [OR], 6.58; p =.04), poor effort to take medication (OR, 5.38; p =.03), and high self-perceived capacity to follow the regimen (OR, 13.76; p =.04). Self-reported adherence and drug plasma levels coincided in 93% of cases. However, differences in adherence did not reach statistical significance in the ITT analysis although a clear tendency toward benefit was observed in EG.
                Specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherence as well as high levels of viral suppression. There is a clear relation between high adherence levels and virologic success. Assessment of certain specific variables related to adherence may be helpful to monitor patient's compliance in the clinical setting. During the past 15 years, programs to improve self-management practices in adults with asthma have reported improvement in functional status and reduction of inappropriate use of health care services. However, these programs usually represent an ideal approach, applying multiple patient education methods. Consequently, when these programs are found to be efficacious, it is important to replicate the programs as well as to evaluate less complex methods that may be more appropriate for nonacademic health care settings.
                We compared the following 3 standardized self-management treatments in a randomized, controlled trial: (1) a replication of the self-management program developed at a university medical center that was previously shown to be efficacious; (2) a modified version of this program including only the core elements; and (3) a usual-care program. Outcome measures included medication and inhaler regimen adherence, asthma symptoms, respiratory illness, functional status, and use of health care resources.
                All 3 groups improved on measures of respiratory illnesses, use of health care services, and functional status. Patients in both education groups did no better than the usual-care group.
                The results are inconsistent with the results of the first asthma self-management study at this institution and with those of efficacy studies of similar programs. Two factors, selection of the patient population and historical changes in asthma treatment, most likely contributed to the lack of impact of the self-management programs. As a result of the improved standards for usual care due to both factors, the opportunity to effect patient outcomes was substantially reduced. To study the efficacy of telephone and mail intervention in therapeutic compliance among patients with mild to moderate hypertension.
                A prospective controlled multicenter clinical trial.
                Eighty-five primary care centers in Spain, with a duration of 6 months.
                A total of 636 patients with newly diagnosed or uncontrolled hypertension were included. Interventions. The patients were randomized and distributed between the following groups: (i) control (CG) - under routine clinical management; (ii) mail intervention (MIG) - received a mailed message reinforcing compliance and reminding of the visits (15 days, 2 and 4 months); (iii) telephone intervention (TIG) - received a telephone call at 15 days, then at 7 and 15 weeks.
                Five visits were scheduled, with the measurement of blood pressure and counting of tablets. Compliers were defined as subjects showing 80-110% drug consumption. Calculations were made of mean percentage compliance (MPC) and compliers, mean blood pressure and percentage controlled subjects.
                Five hundred and thirty-eight patients completed the study (261 males); 85.5% were compliers (CI = 82.5-88.5; n = 460). The MPC was 95.1+/-19.6% (CI = 93.28-96.92). The CG consisted of 182 individuals, MIG = 172 and TIG = 184. Compliers represented 69.2% of the CG (CI 62.5-75.9%), 91.3% (CI = 87.1-95.5) of the MIG (p = 0.0001) and 96.2% of the TIG (CI 93.5-98.9%); the final MPC was 89.6%+/-15 in CG, 96.6%+/-12 in MIG and 99.1+/-26.8 in TIG (p = 0.0001). The percentage of controlled subjects was 47.2% in CG (CI = 40-54.4), 61.3% in MIG (CI = 54.1-68.5%) and 63.3% in TIG (CI = 56.4-70.2%) (p<0.05).
                TIG and MIG are effective measures for improving patient compliance in hypertension. To evaluate the efficacy of a programme of home blood pressure measurement (HBPM) on therapeutic compliance in mild-to-moderate hypertension.
                A prospective controlled multicentre clinical trial.
                Forty primary care centres in Spain, with a duration of 6 months.
                A total of 250 patients with newly diagnosed or uncontrolled hypertension were included.
                The patients were randomly selected and distributed in two groups: (1) the control group (CG) who received standard health intervention; (2) the intervention group (IG): the patients in this group received an OMRON in their homes for a programme of HBPM.
                Four visits were scheduled, for the measurement of blood pressure (BP). They were provided with an electronic monitor for measuring compliance (monitoring events medication system; MEMS). Therapeutic compliance was defined as a drug consumption of 80-110%. A number of variables were calculated using the MEMS. The mean BP were calculated and the percentage of controlled patients.
                A total of 200 patients completed the study (100 in each group). Compliance was observed in 74 and 92%, respectively, in the CG and IG [95% confidence interval (CI) 63.9-84.1 and 86.7-97.3; P = 0.0001], the mean percentage compliances were 87.6 and 93.5% (95% CI 81.2-94 and 80.7-98.3; P = 0.0001), the percentages of correct days were 83.6 and 89.4%, the percentages of subjects who took the medication at the prescribed time were 79.89 and 88.06%, and the levels of therapeutic cover were 86.7 and 93.1%. The number needed to treat to avoid one case of non-compliance was 5.6 patients. The differences in the mean decreases in BP were significant for diastolic BP, with a greater decrease observed in the IG.
                An HBPM programme using electronic monitors is effective in improving compliance in arterial hypertension, measured using the MEMS. This study purported to determine the effect of pretreatment counseling upon discontinuation of 150 mg depot-medroxyprogesterone acetate (Depo-Provera) given for contraception. A total of 350 Mexican women participated: 175 received detailed structured pretreatment counseling about the hormonal effects of the injectable vs. routine counseling upon duration of use and efficacy of the method. Study termination rates were significantly lower in the structured counseling group than in the control group. Cumulative life table discontinuation rates were 17% (30/175) and 43.4% (76/175), respectively (p <0.05). The most common reasons for terminating DMPA were menstrual changes (8.6 and 32% for counseling and control group, respectively). The findings suggest that pretreatment counseling on expected side effects increases the continuation rates of DMPA users. We developed and evaluated a comprehensive, ongoing intervention for families of schizophrenic patients appropriate for China's complex family relationships and unique social environment.
                Sixty-three DSM-III-R schizophrenic patients living with family members were enrolled when admitted to hospital and randomly assigned to receive standard care or a family-based intervention that included monthly 45-minute counselling sessions focused on the management of social and occupational problems, medication management, family education, family group meetings, and crisis intervention.
                At 6, 12, and 18-month follow-ups by blind evaluators, the proportion of subjects rehospitalised was lower, the duration of rehospitalisation was shorter, and the duration of employment was longer in the experimental group than in the control group; these differences were statistically significant at the 12 and 18-month follow-ups and were not explained by differences in drug compliance. Family intervention was associated with significantly lower levels of family burden.
                This intervention is less costly than standard treatment, is suitable for urban families of schizophrenic patients in China and feasible given the constraints of the Chinese mental health system. Asthma education decreases the number of emergency visits in specific subgroups of patients with asthma. However, it remains unknown whether this improvement is related only to the use of an action plan alone or to other components of the educational intervention. A total of 126 patients consulting urgently for an acute asthma exacerbation were recruited; 98 completed the study. The first 45 patients were assigned to Group C (control; usual treatment). Thereafter, patients were randomized to either Group LE (limited education; teaching of the inhaler technique plus self- action plan given by the on call physician) or Group SE (same as group LE plus a structured educational program emphasizing self-capacity to manage asthma exacerbations). At baseline, there was no difference between groups in asthma morbidity, medication needs, or pulmonary function. After 12 mo, only Group SE showed a significant improvement in knowledge, willingness to adjust medications, quality of life scores, and peak expiratory flows. In the last 6 mo, the number of unscheduled medical visits for asthma was significantly lower in Group SE in comparison with groups C and LE (p = 0.03). The number (%) of patients with unscheduled medical visits also decreased significantly in Group SE compared with Groups C and LE (p = 0.02). We conclude that a structured educational intervention emphasizing self-management improves patient outcomes significantly more than a limited intervention or conventional treatment. The aim of this study was to investigate the impact of a pharmacist-led pharmaceutical care programme, involving optimization of drug treatment and intensive education and self-monitoring of patients with heart failure (HF) within the United Arab Emirates (UAE), on a range of clinical and humanistic outcome measures.
                The study was a randomized, controlled, longitudinal, prospective clinical trial at Al-Ain Hospital, Al-Ain, UAE. Patients were recruited from the general medical wards and from cardiology and medical outpatient clinics. HF patients who fulfilled the entrance criteria, and had no exclusion criteria present, were identified for inclusion in the study. After recruitment, patients were randomly assigned to one of two groups: intervention group or control group. Intervention patients received a structured pharmaceutical care service while control patients received traditional services. Patient follow-up took place when patients attended scheduled outpatient clinics (every 3 months). A total of 104 patients in each group completed the trial (12 months). The patients were generally suffering from mild to moderate HF (NYHA Class 1, 29.5%; Class 2, 50.5%; Class 3, 16%; and Class 4, 4%).
                Over the study period, intervention patients showed significant (P < 0.05) improvements in a range of summary outcome measures [AUC (95% confidence limits)] including exercise tolerance [2-min walk test: 1607.2 (1474.9, 1739.5) m.month in intervention patients vs. 1403.3 (1256.5, 1549.8) in control patients], forced vital capacity [31.6 (30.8, 32.4) l.month in the intervention patients vs. 27.8 (26.8, 28.9) in control patients], health-related quality of life, as measured by the Minnesota living with heart failure questionnaire [463.5 (433.2, 493.9) unit.month in intervention patients vs. 637.5 (597.2, 677.7) in control patients; a lower score in this measure indicates better health-related quality of life]. The number of individual patients who reported adherence to prescribed medications was higher (P < 0.05) in the intervention group (85 vs. 35), as was adherence to lifestyle advice (75 vs. 29) at the final assessment (12 months). There was a tendency to have a higher incidence of casualty department visits by intervention patients, but a lower rate of hospitalization.
                The research provides clear evidence that the delivery of pharmaceutical care to patients with HF can lead to significant clinical and humanistic benefits. The prevalence and impact of adult asthma are substantial, and poor self-management practices, especially failures to adhere to treatment regimens, appear to be a significant problem. Desirable characteristics of an intervention program to improve self-management were identified through needs assessment and review of existing patient education resources. A comprehensive program was developed that integrated a workbook with one-to-one counseling and adherence-enhancing strategies. A longitudinal 1-year study compared patients receiving this self-management program with "usual care" patients receiving standard asthma pamphlets. Patients were randomly assigned to conditions. Baseline score and asthma severity were statistically controlled. Self-management patients had substantially better adherence than usual care patients, as well as improved functional status, at follow-up. Hospital and emergency department visits decreased in both groups but did not differ between groups. We investigated whether hospital-based specialist asthma nurses improved recognition and self-treatment of asthma episodes by patients followed up after attending accident and emergency departments (A&E) for asthma exacerbations. We carried out a randomized prospective controlled trial of adult asthma self-management, following a hospital outpatient nurse consultation in two outer-London District General Hospitals (secondary care centres). The study included 211 adults, over 18 years old (mean age 40 years) who attended for asthma in two accident and emergency departments over 13 months. One hundred and eight evaluable patients were randomized into the control group who continued with their usual medical treatment and were not offered any intervention during the study period. One hundred and three evaluable patients were randomized into the intervention group. They were offered three 6-weekly outpatient appointments with one of two specialist asthma nurses for a structured asthma consultation, after attendance at the accident and emergency department. Following assessment of their asthma treatment and control, the nurses advised patients, through the use of self-management-plans, how to recognize and manage uncontrolled asthma and when to seek medical assistance. Medication and inhaler device type were altered if necessary The primary outcome was patient reported self-management of asthma exacerbations for 6 months. Secondary outcomes were assessed at baseline, 3 months and 6 months. These included home peak flow and symptom diaries, structured telephone questionnaires and audit of general practitioner records to determine utilization of services (6 months before and after A&E). Data were analysed on an intention to treat basis by multiple and logistic regression. The intervention group increased their use of inhaled topical steroids in 31/61 (51%) vs. 15/70 (21%) attacks in controls (OR 3.91 CI 1.8-8.4, P<0.001) and their use of rescue medication in 54/61 (89%) severe attacks vs. 53/70 (76%) controls (OR 2.88 CI 1.1-7.9, P<0.05). Intervention patients had significantly higher (mean 20.1 l min(-1); CI 0.4-39.7; P<0.05) and less variable PEF and significantly lower and less variable symptom scores 6 months after entry. Thirty-four percent of intervention patients vs. 42% controls had severe attacks (61 and 70 respectively, OR 0.96 CI 0.7-1.4) during the 6 months. Intervention patients had fewer days off work than controls in the first 3 months (NS) but similar days off during the 6-month period. Intervention patients had fewer episodes away from work in the first (0.34 vs. 0.54, P = 0.08) and the second 3 months (0.25 vs. 0.30, NS) than the controls. Over 80% of the patients records were audited by their general practitioners; the active group had less routine consultations with the doctor (P = 0.03) and practice nurse (P = 0.03), less consultations for uncontrolled episodes (P = 0.06) and less hospital visits (NS) than the controls. Hospital-based specialist nurses reduced asthma morbidity by improving patient self-management behaviour in acute attacks leading to reduced symptoms, improved lung function, less time off work and fewer consultations with health professionals. nan To investigate if an intervention with extra information and support in a group setting to parents of preschool children could improve adherence and clinical outcome.
                This is a controlled, prospective study where the parents of 60 newly diagnosed preschool asthmatic children aged 3 mo-6 y were randomized to either a control group or to an intervention that consisted of four group sessions in close connection with the diagnosis. The basic education on asthma and the written treatment plan were the same in both groups. The outcome measures were questionnaires to the parents and classification of the children according to symptoms and medication. The adherence rate and the burden of asthma were calculated with the help of diaries and weighing of the MDIs used between 12 and 18 mo after inclusion.
                The follow-up rate was 85% after 18 mo. The parents' presence in the sessions was around 70%, with no gender difference. The parents' view on adherence issues improved significantly in the intervention group. In the control group, 30% had poor adherence compared to 8% in the intervention group (p=0.015). Both the parents and the paediatricians underestimated the number of children with poor adherence. The children in the intervention group had significantly fewer exacerbation days during the last 6 mo-2.1 compared to 3.9 d/child-although they had lower inhaled steroid doses after 18 mo. An economic calculation showed that the intervention was profitable.
                This intervention resulted in an improvement in the parents' view on adherence, in the measured adherence rates and in the clinical outcome. To assess the efficacy of a couple-based intervention to improve medication-taking behavior in a clinic population with demonstrated adherence problems.
                A randomized controlled trial (SMART Couples Study) conducted between August 2000 and January 2004.
                Two HIV/AIDS outpatient clinics in New York City.
                Heterosexual and homosexual HIV-serodiscordant couples (n = 215) in which the HIV-seropositive partner had < 80% adherence at baseline. The sample was predominantly lower-income racial/ethnic minorities.
                Participants were randomly assigned to a four-session couple-focused adherence intervention or usual care. The intervention consisted of education about treatment and adherence, identifying adherence barriers, developing communication and problem-solving strategies, optimizing partner support, and building confidence for optimal adherence.
                Medication adherence at week 8 (2 weeks after the intervention) compared with baseline, assessed with a Medication Event Monitoring System cap.
                Intervention participants showed higher mean medication adherence at post-intervention when compared with controls whether adherence was defined as proportion of prescribed doses taken (76% versus 60%) or doses taken within specified time parameters (58% versus 35%). Also, participants in the intervention arm were significantly more likely to achieve high levels of adherence (> 80%, > 90%, or > 95%) when compared with controls. However, in most cases, effects diminished with time, as seen at follow-up at 3 and 6 months.
                The SMART Couples program significantly improved medication adherence over usual care, although the level of improved adherence, for many participants, was still suboptimal and the effect was attenuated over time. The objective of this study was to evaluate whether dispensing prescriptions in the ED affects patient compliance and return visits to the hospital. Seventy-four patients who were deemed suitable candidates for outpatient therapy with a macrolide antibiotic were identified and prospectively randomized to receive either an entire course of azithromycin from the ED or a prescription for azithromycin to be filled at a local pharmacy free of charge. Pharmacy records and telephone interview were used to measure compliance with patients. Significantly fewer patients filled their prescription in the pharmacy group (74.2%) compared with the ED group, in which all patients received their medication. However, there was no difference in the self-reported compliance of completing the entire course of antibiotics between patients in the ED group (94.3%) and in the pharmacy group (96.8%). There was no significant difference between groups in return ED visits or hospital admissions. We conclude that delivery of prescriptions in the ED significantly increases the likelihood that the patient will obtain the medication prescribed. Whether the patients actually take the medication as directed is unknown. Patient's self-report did not accurately reflect true compliance and more objective means for measuring compliance is warranted. This study was conducted to evaluate the effect of automated telephone patient monitoring and counseling on patient adherence to antihypertensive medications and on blood pressure control. A randomized controlled trial was conducted in 29 greater Boston communities. The study subjects were 267 patients recruited from community sites who were >or= 60 years of age, on antihypertensive medication, with a systolic blood pressure (SBP) of >or= 160 mm Hg and/or a diastolic blood pressure (DBP) of >or= 90 mm Hg. The study compared subjects who received usual medical care with those who used a computer-controlled telephone system in addition to their usual medical care during a period of 6 months. Weekly, subjects in the telephone group reported self-measured blood pressures, knowledge and adherence to antihypertensive medication regimens, and medication side-effects. This information was sent to their physicians regularly. The main study outcome measures were change in antihypertensive medication adherence, SBP and DBP during 6 months, satisfaction of patient users, perceived utility for physicians, and cost-effectiveness. The mean age of the study population was 76.0 years; 77% were women; 11% were black. Mean antihypertensive medication adherence improved 17.7% for telephone system users and 11.7% for controls (P = .03). Mean DBP decreased 5.2 mm Hg in users compared to 0.8 mm Hg in controls (P = .02). Among nonadherent subjects, mean DBP decreased 6.0 mm Hg for telephone users, but increased 2.8 mm Hg for controls (P = .01). For telephone system users, mean DBP decreased more if their medication adherence improved (P = .03). The majority of telephone system users were satisfied with the system. Most physicians integrated it into their practices. The system was cost-effective, especially for nonadherent patient users. Therefore, weekly use of an automated telephone system improved medication adherence and blood pressure control in hypertension patients. This system can be used to monitor patients with hypertension or with other chronic diseases, and is likely to improve health outcomes and reduce health services utilization and costs. Allergic rhinitis is an inflammatory disease often associated with bronchial asthma. Intranasal corticosteroids and oral antihistamines are the first-choice drugs. Patient training is relevant to asthma management, but little is known about its impact on rhinitis. We evaluated the role of patient training in the treatment of allergic rhinitis and its effects on nasal and bronchial symptoms.
                One hundred and one patients (M/F = 62/39, age range 12-62 years) with pollen-induced rhinitis (32 with concomitant mild asthma) were enrolled. They were randomized into three groups: A (n = 30) with drug therapy alone, B (n = 35) with drug therapy plus training on the use of nasal spray, and C (n = 36) the same as B plus a lesson on rhinitis and asthma. All patients received mometasone furoate nasal spray for 8 weeks as regular therapy, plus rescue medications on demand. Symptoms and drug consumption were evaluated during the pollen season.
                The rate of noncompliance/dropout was highest in the untrained patients (P = 0.001). No difference in nasal symptoms was seen among the three groups. On the other hand, group C had significantly fewer asthma symptoms (P = 0.02) and less albuterol use (P = 0.005) than group A. Moreover, the trained group globally used less rescue medication than the other groups (P = 0.02).
                Detailed training of patients seems to improve compliance with treatment, reduce concomitant asthma symptoms, and reduce the use of symptomatic drugs. To determine if the intervention of individual advice improves adherence and effectiveness to highly active antiretroviral therapy.
                Randomized open trial. Patients treated with zidovudine + lamivudine + indinavir were assigned (2/1) to conventional care or individual advise. Individual advise consists in adaptation to treatment to patient style of live and detailed information of therapy. Adherence were estimated with structured interview and pillo counts and were considered correct when more than 90% of prescribed drugs were taken.
                Patients 170, conventional care: 110 and IA: 60. Follow-up: 24 weeks. Baseline characteristics were similar in both groups. Correct adherence were estimated in 52.7% of conventional care and in 76.7% of individual advise (p = 0.002, relative risk: 1.45; CI 95%: 1.16-1.82). Undetectable viral load (NASBA < 50 copies/ml) in 54.5% of conventional care and in 65% of individual advise (p = 0.18, relative risk: 1.19; CI 95%: 0.93-1.53). Reduction of viral load in the conventional care group 1.02 +/- 0.5 log10/ml, and in the individual advise group 1.98 +/- 0.7 log10/ml.
                The individual advice improve adherence with a tendency to improve effectiveness of highly active antiretroviral therapy. Background. Patients cite "forgetting" as a reason for nonadherence to highly active antiretroviral therapy (HAART). We measured the effect of a memory-prompting device on adherence to HAART in memory-intact and memory-impaired human immunodeficiency virus (HIV)-infected subjects.Methods. The study was a prospective, randomized, controlled trial involving 64 HIV-infected adults. The intervention was the Disease Management Assistance System (DMAS) device, combined with monthly adherence counseling. Control subjects received only adherence counseling. The DMAS was programmed with HAART regimen data to provide verbal reminders at dosing times. Adherence was measured for 24 weeks using electronic drug exposure monitor (eDEM) caps.Results. A total of 58 subjects completed the 24-week study period; 28 were HAART naive (12 DMAS users and 16 control subjects). Mean adherence scores did not differ significantly between DMAS users (80%) and control subjects (65%). Post hoc analysis of 31 memory-impaired subjects (14 DMAS users and 17 control subjects) revealed significantly higher adherence rates among DMAS users (77%), compared with control subjects (57%) (P=.001). However, analysis of memory-intact subjects showed that adherence was not significantly improved for DMAS users (83%), compared with control subjects (77%) (P=.25). At week twelve, 38% of the DMAS users and 14% of the control subjects had an undetectable plasma HIV RNA load (P=.014), and at week 24, the plasma HIV RNA load was undetectable for 34% of the DMAS users and 38% of the control subjects (P=.49). CD4(+) cell counts did not differ between the study arms. Virological and immunological responses were not related to DMAS use in memory-impaired subjects.Conclusion. The DMAS prompting device improved adherence for memory-impaired subjects but not for memory-intact subjects. The aim of this study was to explore the characteristics and efficacy of psychoeducational family intervention for persons with schizophrenia in rural China.
                A cluster randomised controlled trial of psychoeducational family intervention for families experiencing schizophrenia (three groups, 326 cases) was conducted in Xinjin County, Chengdu. Treatment groups consisted of family intervention and medication, medication alone, and a control.
                The results showed a gain in knowledge, a change in the relatives' caring attitudes towards the patients, and an increase in treatment compliance in the psychoeducational family intervention group (p < 0.05, 0.001). Most importantly, the relapse rate over 9 months in this group (16.3 %) was half that of the drug-only group (37.8 %), and just over one-quarter of that of the control group (61.5 %) (p < 0.05). Antipsychotic drug treatment and families' attitudes towards patients after the 9-month follow-up were significantly associated with clinical outcome (p < 0.05).
                In rural China, family intervention should focus on improving the relatives' recognition of illness, the caring attitude towards the patients, treatment compliance, relapse prevention, and the training of the patients' social functioning. This trial, one of the largest in the literature, has shown that psychoeducational family intervention is effective and suitable for psychiatric rehabilitation in Chinese rural communities. The effects of metoprolol (Betaloc tablets) in a group of 193 hypertensives were compared with the effects of a slow-release formulation (Betaloc Durules) in a further group of 196 patients. Patients were selected at random for treatment. There were no differences between the groups in terms of age, weight, sex, blood pressure, concurrent illness or concomitant therapy. Blood pressure control and apparent adverse effects were similar for both groups; the overall withdrawal rate from each group was similar. Compliance, assessed by tablet counts, was significantly improved in the group receiving once-daily therapy. Simplification of the dosage regimen to once-daily therapy appears to improve the patient's willingness to comply with the physician's instructions. Many patients with major depression are non-adherent to antidepressant medication and do not receive care according to current guidelines. There is increasing evidence that treatment of depression in primary care can be improved. Comparison between effective interventions may help to establish the active ingredients of such interventions.
                In a randomized trial two interventions to improve treatment of major depression in primary care were compared (1) a depression care programme, targeting general practitioners (GPs), patients, and systematic follow-up, and (2) a systematic follow-up programme. Thirty GPs were randomized and 211 primary-care patients with current major depression were included. All patients were prescribed a selective serotonin reuptake inhibitor. Outcome measures included adherence to antidepressant medication, and depression outcome.
                No significant differences in adherence rates and treatment outcome measures were demonstrated between interventions at week 10 or week 26. Adherence rates were high and treatment outcome was favourable.
                The depression care programme was not superior to the systematic follow-up programme. Systematic follow-up in depression treatment in primary care seems to be an intervention per se, having the potential to improve adherence and treatment outcome. A 24-week open-label clinical trial was conducted in 195 HIV-infected adults commonly underrepresented in research (35% female, 71% African American, 21% Hispanic, and 20% injection drug users [IDUs]) to evaluate the effect of an HIV educational program on efficacy and adherence with a simple, compact, twice-daily triple nucleoside regimen containing a lamivudine (150 mg)/zidovudine (300 mg) combination (COM) tablet plus abacavir (ABC), 300 mg. At baseline, the patients' median plasma HIV-1 RNA level was 4.18 log10 copies/mL and the median CD4+ cell count was 379 cells/mm3. Patients were randomized 1:1 to 4 modules of the Tools for Health and Empowerment HIV education intervention plus routine counseling (EI + RC; n = 96) or to routine counseling alone (RC; n = 99). No differences between the EI + RC and RC treatment arms were observed with respect to the proportion of patients achieving plasma HIV-1 RNA levels <40 copies/mL (60% [33/55] vs. 55% [38/69]; P = 0.529) or <400 copies/mL (80% [44/55] vs. 80% [55/69]; P = 0.689) at week 24 (intent-to-treat observed analysis), increase in median CD4 cell count above baseline at week 24 (78.3 vs. 104.8 cells/mm3; P = 0.498), or mean overall adherence rates as measured by the Medication Event Monitoring System (MEMS) (70% vs. 74%). COM + ABC was generally well tolerated, and no association was observed between interruptions in treatment and the development of ABC hypersensitivity (5 suspected cases). In conclusion, in underrepresented patients, the EI used in this study did not affect the efficacy and adherence results with ABC + COM to any greater degree than did RC. Ninety-eight adults treated with erythromycin for a variety of illnesses were randomized to two groups: the informed group received patient education about drug side effects, and the uninformed group were given no such information. Overall, 10% of the uniformed and 8% of the informed group felt the erythromycin bothered them in some way. There were no significant differences in the occurrence of various individual side effects. Compliance with therapy and the results of treatment were the same for both groups. In this study, informing patients about side effects of therapy did not have any detectable adverse effects. This article reports a randomized controlled trial designed to test the effects of special packaging of antihypertensive medication on compliance and blood pressure control. One hundred eighty subjects who had exhibited elevated blood pressure greater than 90 mmHg in the two years prior to the study were recruited from patients receiving care at a community hospital-based family medicine practice. After completing preenrollment interviews and blood pressure measurements, subjects were randomly assigned to receive their antihypertensive medications either in the usual vials or in special unit dose-reminder packaging. Follow-up interviews, pill counts, and blood pressure measurements were performed at three-month intervals. There were no statistically significant differences between the control and experimental groups with regard to age, sex, race, employment, education, marital status, insurance coverage, or blood pressure regimens. Prior to the intervention, the experimental group had slightly lower diastolic blood pressure and reported better compliance than the control group. Analyses performed on 165 subjects completing the first follow-up visit revealed no significant improvements in blood pressure control or compliance for patients receiving special medication packaging. While some patients found it easy to remember to take pills packaged using this format, they also found the packages somewhat more difficult and inconvenient to use. In contrast to previously reported work, this study did not demonstrate any significant improvement in compliance with special packaging of antihypertensive medications. Fifty-three hospital outpatients with epilepsy were randomly allocated to either a control or an intervention group. Patients in the intervention group were subjected to a combination of compliance-improving strategies: patient counselling, a special medication container, self-recording of medication intake and seizures, and mailed reminders to collect prescription refills and attend clinic appointments. Compliance with anticonvulsant therapy (as measured by plasma anticonvulsant levels and prescription refill frequencies), and seizure frequency, were evaluated in each patient prior to intervention and 6 months afterwards. Patient compliance and clinical control improved significantly in the intervention group patients. Seizure frequency was, on average, halved following intervention. Compliance and seizure frequency were unaltered in the control group. Intervention failed to improve clinic appointment keeping. Poor compliance with drug therapy commonly confounds the treatment of epilepsy. This study shows that compliance can be improved and seizure frequency lessened by strategies that are easily incorporated into the routine management of epileptic patients. To evaluate a pharmacist-conducted educational and monitoring programme, designed to promote dietary and lifestyle modification and compliance with lipid-lowering drug therapy, for patients with dyslipidaemia.
                This was a prospective, randomized, controlled study. The participants were 94 adults, with 81 completing the study (intervention group: 39; control group: 42), with a cardiovascular-related diagnosis and discharged from hospital, between April and October 2001, on lipid-lowering drug therapy. Patients in the intervention group were visited at home monthly by a pharmacist, who educated the patients on the goals of lipid-lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy, assessed patients for drug-related problems, and measured total blood cholesterol levels using point-of-care testing. Patients in the control group received standard medical care. The main outcome measure was total blood cholesterol levels after 6 months, and an evaluation of patient and general practitioner satisfaction with the programme.
                There was no significant difference in baseline total blood cholesterol levels between the two groups. The reduction over the course of the study in cholesterol levels within the intervention group was statistically significant (4.9 +/- 0.7 to 4.4 +/- 0.6, P<0.005), whereas there was no change within the control group (P=0.26). At follow-up, 44% of the intervention group patients and 24% of the control group patients had cholesterol levels below 4.0 mmol/L (P=0.06). The reduction in total cholesterol in the intervention group should translate to an expected 21% reduction in cardiovascular mortality risk and a 16% reduction in total mortality risk--more than twice the risk reduction achieved in the control group. In addition, the programme was very well received by the patients and their general practitioners, by satisfaction questionnaire.
                A pharmacist-conducted educational and monitoring intervention improved the outcomes of lipid-lowering drug therapy. Poor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence.
                To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C).
                A multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006.
                After a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months.
                Primary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence.
                A total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (-6.9 mm Hg; 95% CI, -10.7 to -3.1 mm Hg) vs the usual care group (-1.0 mm Hg; 95% CI, -5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions.
                A pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence.
                clinicaltrials.gov Identifier: NCT00393419 Helicobacter pylori (H. pylori) eradication rate varies according to the treatment regimen used and other factors, e.g. antimicrobial resistance and patient compliance. The aim of the present study was to evaluate the influence of patient counselling and follow-up on H. pylori eradication rates and to document the effectiveness of a 1 week eradication regimen consisting of lansoprazole (30 mg once daily), amoxicillin (1 g twice daily) and clarithromycin (500 mg twice daily).
                Seventy-six dyspeptic patients, who at endoscopy were found to have gastritis, duodenitis or ulceration, and a positive H. pylori urease test, were recruited. Patients were randomly assigned to an intervention group (n = 38) or a control group (n = 38). Intervention patients received their medicines via the hospital pharmacy and were counselled (and followed up) by a hospital pharmacist. Control patients were given a standard advice sheet and referred to their GP who prescribed the same therapy.
                Intervention patients exhibited a statistically significant improvement in the H. pylori eradication rate (94.7% vs 73.7%; P = 0.02) and compliance (92.1% vs 23.7; P < 0.001). Of the 64 H. pylori eradicated patients, 62 were able to eliminate their antisecretory medication compared with only 12 of the H. pylori persistent patients (P < 0.001). A pharmacoeconomic evaluation indicated that counselling and follow-up reduced the direct costs of eradication by approximately 30 UK pounds per patient.
                Structured patient counselling and follow-up can have a significant effect on H. pylori eradication rates and should be a routine part of therapy. to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients.
                randomized controlled trial.
                we randomized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care.
                the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient. A copy was given to the patient and to all relevant professionals and carers. This was followed by a domiciliary assessment by a community pharmacist. In the control group, patients were discharged from hospital following standard procedures that included a discharge letter to the general practitioner listing current medications.
                the primary outcome was re-admission to hospital within 6 months. Secondary outcomes included the number of deaths, attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period, together with patients' general well-being, satisfaction with the service and knowledge of and adherence to prescribed medication.
                we recruited 362 patients, of whom 181 were randomized to each group. We collected hospital and general practice data on at least 91 and 72% of patients respectively at each follow-up point and interviewed between 43 and 90% of the study subjects. There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months. There were no significant differences in any of the secondary outcomes.
                we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes. The purpose of the study was to compare three nursing interventions and their impact on glycemic control among children with type I diabetes. The 75 subjects' mean +/- SD age was 12.5 +/- 3.4 years, 55% were boys, and 55% were White. Subjects were randomly assigned to a standard care (SC), an education (ED), or an education and telephone case management (ED + TCM) group. The primary outcome measure was glycemic control (hemoglobin A1c, or HbA1c). Secondary outcome measures were diabetes knowledge (KNOW), parent-child teamwork (TEAM), and adherence (ADH). After 6 months of follow-up, results demonstrated no significant differences among groups in HbA1c. KNOW and TEAM scores improved slightly in the ED and ED + TCM groups, but no statistically significant differences were found among the three groups. Significant improvement in ADH scores among ED + TCM groups was reported when compared with the ED and SC groups. This change may represent a move toward improved adherence to diabetes care and subsequent improvement in diabetes control. The challenges of recruitment and retention of subjects in this study will also be discussed. This paper evaluates the effects on knowledge and clinical stability of an educational intervention about tardive dyskinesia.
                Fifty-six patients receiving antipsychotic maintenance completed a questionnaire assessing their knowledge about tardive dyskinesia. After random allocation to either an educational intervention or a control group, their knowledge was reassessed at six months.
                Ninety-five per cent of patients completed the study. The study patients gained significantly more knowledge than the controls, who made modest gains. There were no significant differences in clinical outcome between the groups.
                Patients can learn about serious toxic effects of antipsychotic treatment with a low risk of non-compliance. Discussion about tardive dyskinesia is necessary in the process of obtaining informed consent to treatment. Adherence to antiretroviral therapy is critical to treatment outcomes. Adherence studies in other therapeutic areas of medicine suggest that once-daily regimens support improved adherence when compared to twice-daily therapy. An expansion in the range of once-daily antiretrovirals is making once-daily therapy possible for persons with HIV infection.
                A 24-week randomized open-label simplification study of twice-daily regimens based on stavudine immediate release or zidovudine to an all once-daily regimen based on the stavudine prolonged-release capsule (PRC), in persons with complete virological suppression on regimens also including efavirenz and lamivudine, was carried out. Subjects were assessed for adherence [using the Medication Event Monitoring System (MEMS) cap; Aardex Corporation, Union City, CA, USA], quality of life, tolerability and efficacy.
                Forty-three patients were randomly assigned: 21 remained on their original regimen and 22 switched to once-daily therapy with stavudine PRC. Although high levels of adherence and good quality of life were present at study enrollment, adherence declined to a significantly lesser extent at week 24 in the group that switched to once-daily therapy. Efficacy was maintained in both groups and there were no differences in tolerability or toxicity.
                Subjects switching from twice-daily therapy to once-daily therapy demonstrate less of a decline in adherence over 24 weeks. A once-daily regimen including stavudine PRC is as effective and tolerable as a regimen containing the twice-daily formulation. The impact of an adherence enhancement program for low income HIV-infected Spanish-speaking Latinos on health literacy, patient-provider relationships, and adherence to HAART was examined. Evaluations were conducted at baseline, 6 weeks, and 6 months for participants (n = 85) randomly assigned to either the intervention group or a comparison group; 69 (81%) remained in the study for the entire 6-month duration. The intervention group scored significantly better than the comparison group on 3 of 5 measures of HIV health literacy at 6 weeks and on 2 of 5 measures, at 6 months. While there was a weak trend for the intervention group to report an increase in self-efficacy of medication adherence management, baseline to 6 weeks, no other changes were significant. Perceptions of the quality of relationship and communications with their HIV-treating physicians improved both at 6 weeks (p = 0.04) and at 6 months (p < 0.001). The comparison group showed little change baseline to 6 weeks and baseline to 6 months. While there was a trend for the pilot group to report better medication adherence, these differences were not statistically significant. Further evaluation of the impact of this adherence enhancement program is needed. Lack of medication adherence is a common reason for poor control of blood pressure in the community, increasing the risk of heart attacks and strokes.
                To evaluate the effect of nurse-led adherence support for people with uncontrolled high blood pressure compared with usual care.
                We recruited 245 women and men with uncontrolled hypertension (> or = 150/90 mmHg) from 21 general practices in Bristol, UK. Participants were randomized to receive nurse-led adherence support or usual care alone. Main outcome measures were adherence to medication ('timing compliance') and blood pressure.
                Mean baseline timing compliance (+/- SD) was high in both the intervention (90.8 +/- 15.6%) and the control group (94.5 +/- 7.6%). There was no evidence of an effect of the intervention on timing compliance at follow-up (adjusted difference in means -1.0%; 95% confidence interval (CI) -5.1 to 3.1). There was also no difference at follow-up between the groups with regard to systolic blood pressure (-2.7 mmHg; 95% CI -7.2 to 1.8) or diastolic blood pressure (0.2 mmHg; 95% CI -1.9 to 2.3). Projected costs for the primary care sector per consultation were 6.60 pound sterling for the intervention compared with 5.08 pound sterling for usual care.
                In this study, adherence to blood pressure medication was much higher than previously reported. There was no evidence of an effect of nurse-led adherence support on medication adherence or blood pressure compared with usual care. Nurse-led adherence support was also more expensive from a primary care perspective. The aim of this study was to compare cure rates of Helicobacter pylori (H. pylori) infection, compliance, and side effects in patients given 10 days of omeprazole 20 mg b.d., amoxycillin 500 mg t.d.s., and metronidazole 400 mg t.d.s. (OAM) or 10 days OAM plus compliance enhancing measures.
                A total of 119 H. pylori-positive patients were prospectively randomized to receive either 10 days OAM or 10 days OAM plus compliance enhancing measures (medication in a dose dispensing unit, medication chart, an information sheet about H. pylori treatment, and phone call 2 days after starting therapy). H. pylori eradication was assessed by 13C-UBT at least 4 wk after cessation of therapy, compliance by phone interview on the last day of therapy and returned pill count, and side effects by phone interview and returned side effects form.
                In 113 patients attending 13C-UBT H. pylori was eradicated in 51 of 57 patients (89.5%) after 10 days OAM and in 48 of 56 (85.7%) after 10 days OAM plus compliance enhancing measures (p = 0.54). In both groups 97% of medications were taken. Side effects were common (82% of patients). Both side effects (p = 0.001) and ulcer versus nonulcer at endoscopy (p = 0.016) were independent predictors of treatment failure; side effects also predicted noncompliance (p = 0.02).
                Ten days of OAM was effective for H. pylori eradication in our clinical population. Patient compliance was excellent and attempts to increase compliance had no impact on outcome or compliance. Side effects were very common and were significantly associated with treatment failure and decreased compliance. To assess the effectiveness of an individualized multicomponent intervention to promote adherence to antiretroviral therapy (ART) in a cohort of HIV-infected individuals with a history of alcohol problems.
                We conducted a randomized controlled trial to compare the usual medical follow-up with an adherence intervention.
                The principal enrolment site was Boston Medical Center, a private, not-for-profit, academic medical institution.
                HIV-infected patients with a history of alcohol problems on ART. A total of 151 were enrolled and 141 (93%) were assessed at follow-up. Intervention: A nurse, trained in motivational interviewing, completed the following over 3 months in four encounters: addressed alcohol problems; provided a watch with a programmable timer to facilitate pill taking; enhanced perception of treatment efficacy; and delivered individually tailored assistance to facilitate medication use.
                Prior 30-day adherence > or =95%, prior 3-day adherence of 100%, CD4 cell count, HIV RNA and alcohol consumption, each at both short- and long-term follow-up.
                At follow-up, no significant differences in medication adherence, CD4 cell count, HIV RNA or alcohol consumption were found (all P values >0.25).
                A multicomponent intervention to enhance adherence among HIV-infected individuals with a history of alcohol problems was not associated with changes in medication adherence, alcohol consumption or markers of HIV disease progression. The failure to change adherence in a group at high risk for poor adherence, despite utilizing an intensive individual-focused patient intervention, supports the idea of addressing medication adherence with supervised medication delivery or markedly simplified dosing regimens. To compare patients' adherence to therapy, expectations, satisfaction with pharmacy services, and health-related quality of life (HRQOL) after the provision of pharmaceutical care with those of patients who received traditional pharmacy care.
                Randomized controlled cluster design.
                Sixteen community pharmacies in Alberta, Canada.
                Ambulatory elderly (> or = 65 years of age) patients covered under Alberta Health & Wellness's senior drug benefit plan and who were concurrently using three or more medications according to pharmacy profiles.
                Pharmacies were randomly assigned to either treatment (intervention) or control (traditional pharmacy care) groups. Patients at treatment pharmacies were recruited into the study, and pharmacists provided comprehensive pharmaceutical care services. Pharmacists at control pharmacies continued to provide traditional pharmacy care.
                Study participants' opinions, adherence to therapy, and scores on the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).
                Compared with those of patients receiving traditional care, treatment patients' expectations that their pharmacist would perform activities congruent with pharmaceutical care changed over the study period. Treatment patients' satisfaction with the constructs "trust," "evaluation and goal setting," and "communicates with doctor" were also positively affected. HRQOL and patient adherence were not significantly affected by pharmaceutical care interventions.
                Successful implementation of a pharmaceutical care practice model has the potential to increase patients' satisfaction with their pharmacists' activities and may increase patients' expectations that pharmacists will work on their behalf to assist them with their health care needs. If pharmaceutical care affects patients' HRQOL, instruments more specific than the SF-36 may be needed to detect the differences. To determine the effectiveness of structured adherence counseling by pharmacists on the eradication of Helicobacter pylori when using a standard drug treatment regimen.
                Randomized controlled clinical trial.
                Nonprofit group-practice health maintenance organization (HMO).
                HMO primary care providers referred 1,393 adult dyspeptic patients for carbon 14 urea breath testing (UBT).
                Those whose tests were positive for H pylori (23.3%) were provided a standard antibiotic regimen and randomly assigned to receive either usual-care counseling from a pharmacist or a longer adherence counseling session and a follow-up phone call from the pharmacist during drug treatment. All subjects were given the same 7-day course of omeprazole, bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (OBMT). Dyspepsia symptoms were recorded at baseline and following therapy.
                The main outcome was eradication of H pylori as measured by UBT at 3-month follow-up. Secondary outcomes were patient satisfaction and dyspepsia symptoms at 3-month follow-up.
                Of the 333 participants randomly assigned to treatment, 90.7% completed the 3-month follow-up UBT and questionnaires. Overall eradication rate with the OBMT regimen was 80.5% with no significant difference in eradication rates between the 2 groups (P=0.98). Conclusions In this study, additional counseling by pharmacists did not affect self-reported adherence to the treatment regimen, eradication rates, or dyspepsia symptoms but did increase patient satisfaction. The aim of the study was to assess the respective roles of the half-life of elimination of oral anticoagulants and patient education as causes of instability of anticoagulation level in patients on oral anticoagulant therapy. Patients were randomised to receive either warfarin (long half-life) or acenocoumarol (short half-life) and either intensive or standard education, according to a factorial design. Instability of oral anticoagulant therapy was evaluated by the percentage of INRs and the time within the target range, and the variability between successive measurements. Compliance was assessed by means of electronic pill bottles. Eighty-six patients were included. Apart from the variability index, instability was similar between groups. Correlations between compliance and instability were observed only in the acenocoumarol group. No difference was found between the education groups. In patients starting oral anticoagulant therapy, dose determination may be the most important factor contributing to instability. A high level of adherence to antiretroviral therapy is required for complete suppression of HIV replication, immunological and clinical effectiveness. We investigated whether cognitive behaviour therapy can improve medication adherence.
                Prospective randomized 1-year trial.
                Collaboration of HIV university outpatient clinic and psychotherapists in private practice.
                60 HIV-infected persons on stable antiretroviral combination therapy and viral load below 50 copies/ml.
                Cognitive behaviour intervention in individual patients, in addition to standard of care.
                Feasibility and acceptance of intervention; adherence to therapy assessed using medication event monitoring system (MEMS) and self-report questionnaire; virological failure; psychosocial measures.
                The median number of sessions for cognitive behaviour intervention per patient during the 1-year trial was 11 (range 2-25). At months 10-12, mean adherence to therapy as assessed using MEMS was 92.8% in the intervention and 88.9% in the control group (P=0.2); the proportion of patients with adherence > or = 95% was 70 and 50.0% (P=0.014), respectively. While there was no significant deterioration of adherence during the study in the intervention arm, adherence decreased by 8.7% per year (P=0.006) in the control arm. No differences between the intervention group and standard of care group were found regarding virological outcome. Compared with the control group, participants in the intervention group perceived a significant improvement of their mental health during the study period.
                Cognitive behavioural support in addition to standard of care of HIV-infected persons is feasible in routine practice, and can improve medication adherence and mental health. To determine whether a patient education programme (PE) would improve rates of adherence to a slow acting antirheumatic drug and to assess any subsequent effect on patient outcome.
                A randomly controlled study comprising 100 patients with rheumatoid arthritis (49 control CG; 51 experimental EG) requiring D-penicillamine (DPA). The same practitioner saw patients on seven occasions, for the same length of time. The EG received 7 x 30 minute one to one sessions of PE, while the CG received standard management. The primary measure of adherence was a pharmacological marker (phenobarbitone) encapsulated with the DPA assayed at monthly intervals for six months. Plasma viscosity (PV), C reactive protein, articular index, morning stiffness, and pain score were used to assess outcome.
                454 blood samples were collected and assayed and the pharmacological marker showed the EG to be significantly more adherent on more occasions than the CG (p<0.05). Patterns of adherence over time showed that at 12 weeks 86% (38/44) of those in the EG compared with 64% (29/45) of the CG remained adherent (p=0.01). These trends continued and by the end of the study 85% (29/34) of the EG compared with 55% (23/42) of the CG were taking their DPA as prescribed. Fifteen patients (12 from the EG) experienced side effects requiring study withdrawal and 14 patients requested study withdrawal (two from the EG). On study entry patients in the CG had significantly higher levels of PV than the EG and this remained so throughout the research. However, on completion, the health status of patients in both groups had improved significantly (p<0.01).
                PE significantly increased adherence to DPA and its effects persisted over a period of six months. No additional clinical benefit was detected in the EG in comparison with the CG.
For short-term treatments several quite simple interventions increased adherence and improved patient outcomes, but the effects were inconsistent from study to study with less than half of studies showing benefits. Current methods of improving adherence for chronic health problems are mostly complex and not very effective, so that the full benefits of treatment cannot be realized. High priority should be given to fundamental and applied research concerning innovations to assist patients to follow medication prescriptions for long-term medical disorders.