A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Translating the Chronic Care Model Into the Community: Results From a Randomized Controlled Trial of a Multifaceted Diabetes Care Intervention Effect of shared care on blood pressure in patients with chronic kidney disease: a cluster randomised controlled trial. Effects of Structured Versus Usual Care on Renal Endpoint in Type 2 Diabetes: The SURE Study Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system. SA Healthplus: A Controlled Trial of a Statewide Application of a Generic Model of Chronic Illness Care Evaluation of the UCL Diabetes Self-management Programme (UCL-DSMP): A Randomized Controlled Trial The United Kingdom Expert Patients Programme: results and implications from a national evaluation. Predictors of Health-Related Quality of Life in Patients with Co-Morbid Diabetes and Chronic Kidney Disease Two self-management interventions to improve hypertension control: a randomized trial. Effectiveness of multidisciplinary care for chronic kidney disease in Taiwan: a 3-year prospective cohort study. Chronic disease management: what will it take to improve care for chronic illness? The Vermont Diabetes Information System (VDIS): study design and subject recruitment for a cluster randomized trial of a decision support system in a regional sample of primary care practices A multifactorial intervention to improve blood pressure control in co-existing diabetes and kidney disease: a feasibility randomized controlled trial. What is the threshold for a clinically relevant effect? The case of major depressive disorders.
BACKGROUND AND OBJECTIVES It is unclear how to optimally care for chronic kidney disease ( CKD ) . This study compares a new coordinated model to usual care for CKD . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS A r and omized trial in nephrology clinics and the community included 474 patients with median estimated GFR ( eGFR ) 42 ml/min per 1.73 m(2 ) identified by laboratory-based case finding compared care coordinated by a general practitioner ( controls ) with care by a nurse-coordinated team including a nephrologist ( intervention ) for a median ( interquartile range [ IQR ] ) of 742 days . 32 % were diabetic , 60 % had cardiovascular disease , and proteinuria was minimal . Guided by protocol s , the intervention team targeted risk factors for adverse kidney and cardiovascular outcomes . Serial eGFR and clinical events were tracked . RESULTS The average decline in eGFR over 20 months was -1.9 ml/min per 1.73 m(2 ) . eGFR declined by ≥4 ml/min per 1.73 m(2 ) within 20 months in 28 ( 17 % ) intervention patients versus 23 ( 13.9 % ) control patients . Control of BP , LDL , and diabetes were comparable across groups . In the intervention group there was a trend to greater use of renin-angiotensin blockers  and more use of statins  in those with initial LDL > 2.5 mmol/L. Treatment was rarely required for anemia , acidosis , or disordered mineral metabolism . Clinical events occurred in 5.2 % per year . CONCLUSIONS Patients with stage 3/4 CKD identified through community laboratories largely had nonprogressive kidney disease but had cardiovascular risk . Over a median of 24 months , the nurse-coordinated team did not affect rate of GFR decline or control of most risk factors compared with usual care OBJECTIVES This study evaluated the effectiveness ( changes in health behaviors , health status , and health service utilization ) of a self-management program for chronic disease design ed for use with a heterogeneous group of chronic disease patients . It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities . METHODS The study was a six-month r and omized , controlled trial at community-based sites comparing treatment subjects with wait-list control subjects .  Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease , lung disease , stroke , or arthritis .  Health behaviors , health status , and health service utilization , as determined by mailed , self-administered question naires , were measured . RESULTS Treatment subjects , when compared with control subjects , demonstrated improvements at 6 months in weekly minutes of exercise , frequency of cognitive symptom management , communication with physicians , self-reported health , health distress , fatigue , disability , and social/role activities limitations . They also had fewer hospitalizations and days in the hospital . No differences were found in pain/physical discomfort , shortness of breath , or psychological well-being . CONCLUSIONS An intervention design ed specifically to meet the needs of a heterogeneous group of chronic disease patients , including those with comorbid conditions , was feasible and beneficial beyond usual care in terms of improved health behaviors and health status . It also result ed in fewer hospitalizations and days of hospitalization OBJECTIVE To determine whether using the chronic care model ( CCM ) in an underserved community leads to improved clinical and behavioral outcomes for people with diabetes . RESEARCH DESIGN AND METHODS This multilevel , cluster- design , r and omized controlled trial examined the effectiveness of a CCM-based intervention in an underserved urban community . Eleven primary care practice s , along with their patients , were r and omized to three groups : CCM intervention ( n = 30 patients ) , provider education only ( PROV group ) ( n = 38 ) , and usual care ( UC group ) ( n = 51 ) . RESULTS A marked decline in HbA(1c ) was observed in the CCM group ( -0.6 % , P = 0.008 ) but not in the other groups . The magnitude of the association remained strong after adjustment for clustering ( P = 0.01 ) . The same pattern was observed for a decline in non-HDL cholesterol and for the proportion of participants who self-monitor blood glucose in the CCM group ( non-HDL cholesterol : -10.4 mg/dl , P = 0.24 ; self-monitor blood glucose : + 22.2 % , P < 0.0001 ) , with statistically significant between-group differences in improvement ( non-HDL cholesterol : P = 0.05 ; self-monitor blood glucose : P = 0.03 ) after adjustment . The CCM group also showed improvement in HDL cholesterol ( + 5.5 mg/dl , P = 0.0004 ) , diabetes knowledge test scores ( + 6.7 % , P = 0.07 ) , and empowerment scores ( + 2 , P = 0.02 ) . CONCLUSIONS These results suggest that implementing the CCM in the community is effective in improving clinical and behavioral outcomes in patients with diabetes BACKGROUND Chronic kidney disease ( CKD ) is highly prevalent in patients with diabetes or hypertension in primary care . A shared care model could improve quality of care in these patients AIM To assess the effect of a shared care model in managing patients with CKD who also have diabetes or hypertension . Design and setting A cluster r and omised controlled trial in nine general practice s in The Netherl and s. METHOD Five practice s were allocated to the shared care model and four practice s to usual care for 1 year . Primary outcome was the achievement of blood pressure targets ( 130/80 mmHg ) and lowering of blood pressure in patients with diabetes mellitus or hypertension and an estimated glomerular filtration rate (eGFR)<60 ml/min/1.73 m(2 ) . RESULTS Data of 90 intervention and 74 control patients could be analysed . Blood pressure in the intervention group decreased with 8.1 ( 95 % CI = 4.8 to 11.3)/1.1 ( 95 % CI = -1.0 to 3.2 ) compared to -0.2 ( 95 % CI = -3.8 to 3.3)/-0.5 ( 95 % CI = -2.9 to 1.8 ) in the control group . Use of lipid-lowering drugs , angiotensin-system inhibitors and vitamin D was higher in the intervention group than in the control group ( 73 % versus 51 % , 81 % versus 64 % , and 15 % versus 1 % , respectively , [ P = 0.004 , P = 0.01 , and P = 0.002 ] ) . CONCLUSION A shared care model between GP , nurse practitioner and nephrologist is beneficial in reducing systolic blood pressure in patients with CKD in primary care OBJECTIVE Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes . We hypothesized that structured care would reduce renal complications in type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150–350 μmol/l were r and omly assigned to receive structured care ( n = 104 ) or usual care ( n = 101 ) for 2 years . The structured care group was managed according to a prespecified protocol with the following treatment goals : blood pressure < 130/80 mmHg , A1C < 7 % , LDL cholesterol < 2.6 mmol/l , triglyceride < 2 mmol/l , and persistent treatment with renin-angiotensin blockers . The primary end point was death and /or renal end point ( creatinine > 500 μmol/l or dialysis ) . RESULTS Of these 205 patients ( mean ± SD age 65 ± 7.2 years ; disease duration 14 ± 7.9 years ) , the structured care group achieved better control than the usual care group ( diastolic blood pressure 68 ± 12 vs. 71 ± 12 mmHg , respectively , P = 0.02 ; A1C 7.3 ± 1.3 vs. 8.0 ± 1.6 % , P < 0.01 ) . After adjustment for age , sex , and study sites , the structured care ( 23.1 % , n = 24 ) and usual care ( 23.8 % , n = 24 ; NS ) groups had similar end points , but more patients in the structured care group attained ≥3 treatment goals ( 61 % , n = 63 , vs. 28 % , n = 28 ; P < 0.001 ) . Patients who attained ≥3 treatment targets ( n = 91 ) had reduced risk of the primary end point ( 14 vs. 34 ; relative risk 0.43 [ 95 % CI 0.21–0.86 ] compared with that of those who attained ≤2 targets ( n = 114 ) . CONCLUSIONS Attainment of multiple treatment targets reduced the renal end point and death in type 2 diabetes . In addition to protocol , audits and feedback are needed to improve outcomes Background Implementation of self-management support in traditional primary care setting s has proved difficult , encouraging the development of alternative models which actively link to community re sources . Chronic kidney disease ( CKD ) is a common condition usually diagnosed in the presence of other co-morbidities . This trial aim ed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD . Methods and Findings In a pragmatic , two-arm , patient level r and omised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practice s in Greater Manchester . Patients were r and omised to intervention ( 215 ) or usual care ( 221 ) . Primary outcome measures were health related quality of life ( EQ-5D health question naire ) , blood pressure control , and positive and active engagement in life ( heiQ ) at 6 months . At 6 months , mean health related quality of life was significantly higher for the intervention group ( adjusted mean difference = 0.05 ; 95 % CI = 0.01 , 0.08 ) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group ( adjusted odds-ratio = 1.85 ; 95 % CI = 1.25 , 2.72 ) . Patients did not differ significantly in positive and active engagement in life . The intervention group reported a reduction in costs compared with control . Conclusions An intervention to provide tailored information and telephone-guided access to community re sources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care . However , further research is required to identify the mechanisms of action of the intervention . Trial Registration Controlled-Trials.com IS RCT IMPORTANCE Self-monitoring of blood pressure with self-titration of antihypertensives ( self-management ) results in lower blood pressure in patients with hypertension , but there are no data about patients in high-risk groups . OBJECTIVE To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease , diabetes , or chronic kidney disease . DESIGN , SETTING , AND PATIENTS A primary care , unblinded , r and omized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke , coronary heart disease , diabetes , or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practice s was conducted between March 2011 and January 2013 . INTERVENTIONS Self-monitoring of blood pressure combined with an individualized self-titration algorithm . During the study period , the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg . Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary . MAIN OUTCOMES AND MEASURES The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit . RESULTS Primary outcome data were available from 450 patients ( 81 % ) . The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group . After 12 months , the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group , a difference of 9.2 mm Hg ( 95 % CI , 5.7 - 12.7 ) in systolic and 3.4 mm Hg ( 95 % CI , 1.8 - 5.0 ) in diastolic blood pressure following correction for baseline blood pressure . Multiple imputation for missing values gave similar results : the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group , and at 12 months , the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group , with a difference of 8.8 mm Hg ( 95 % CI , 4.9 - 12.7 ) for systolic and 3.1 mm Hg ( 95 % CI , 0.7 - 5.5 ) for diastolic blood pressure between groups . These results were comparable in all subgroups , without excessive adverse events . CONCLUSIONS AND RELEVANCE Among patients with hypertension at high risk of cardiovascular disease , self-monitoring with self-titration of antihypertensive medication compared with usual care result ed in lower systolic blood pressure at 12 months . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N87171227 OBJECTIVE To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model ( CCM ) . PARTICIPANTS AND METHODS As part of the CCM , 97 primary care physicians at 6 primary care practice s in Rochester , MN , referred 639 patients to an on-site diabetes educator between July 1 , 2001 , and December 31 , 2003 . On first referral , physicians were central ly r and omized to receive a telemedicine intervention ( specialty advice and evidence -based messages regarding medication management for cardiovascular risk ) or no intervention , keeping outcome assessors and data analysts blinded to group assignment . After each subsequent clinical encounter , endocrinologists review ed an abstract from the patient 's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail . Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes . Outcome measures included diabetes care processes ( diabetes test completion ) , outcomes ( metabolic and cardiovascular risk factors , estimated coronary artery disease risk ) , and patient costs ( payer perspective ) . RESULTS During the intervention , 951 ( 70 % ) of the 1361 endocrinology review s detected performance gaps and result ed in a message ; primary care physicians reported using 49 % of messages in patient care . With a mean of 21 months ' follow-up , the intervention , compared with control , did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease ( adjusted mean difference , -1 % ; 95 % confidence interval , -19 % to 17 % ) . The intervention group incurred lower costs ( P=.02 ) but not in diabetes-related costs . CONCLUSION Specialty telemedicine did not significantly enhance the value of CCM in primary care SA HealthPlus , one of nine national Australian coordinated care trials , addressed chronic illness care by testing whether coordinated care would improve health outcomes at the cost of usual care . SA HealthPlus compared a generic model of coordinated care for 3,115 intervention patients with the usual care for 1,488 controls . Service coordinators and the behavioral and care-planning approach were new . The health status ( SF-36 ) in six of eight projects improved , and those patients who had been hospitalized in the year immediately preceding the trial were the most likely to save on costs . A mid-trial review found that health benefits from coordinated care depended more on patients ' self-management than the severity of their illness , a factor leading to the Flinders Model of Self-Management Support Self-management has been described as the cornerstone of care for diabetes . Many self-management studies are limited by poor methodology and poor descriptions of the intervention . The current study developed a theoretically based self-management programme for patients with type 2 diabetes , which was evaluated via a r and omized controlled trial . At immediate post-intervention and three-month follow-up the intervention group showed significant improvement relative to controls on self-management behaviours , quality of life and illness beliefs . A trend towards improved HbA1c was also observed . Documentation in a manual and development of a training programme for facilitators ensures the programme is replicable The Expert Patients Programme ( EPP ) is a central element of chronic disease management policy in the United Kingdom . It aims to deliver self-care support by developing peoples ' self-care skills , confidence and motivation to take more effective control over their long-term conditions . A large , national r and omised controlled trial found that the EPP 's lay-led skills training was effective in improving self-efficacy and energy levels among patients with long-term conditions , and was likely to be cost-effective . Key questions remain as to whether existing outcome measures capture the core outcomes that are important to patients with long-term conditions . The development and evaluation of self-care support initiatives should take into account the extent to which self-care support initiatives can be integrated into peoples ' everyday lives , and the degree of fit with patients ' existing adaptations and strategies . Rather than being concentrated on a single course , central re sources for self-management support should be directed at a variety of systems and interventions that are able to meet the wide range of needs of patients with chronic conditions Background People living with diabetes and chronic kidney disease ( CKD ) experience compromised quality of life . Consequently , it is critical to identify and underst and factors influencing their health-related quality of life ( HRQoL ) . This study examined factors associated with HRQoL among patients with diabetes and CKD . Methods A cross sectional study among adults with comorbid diabetes and CKD ( eGFR < 60 mL/min/1.73m2 ) recruited from renal and diabetes clinics of four large tertiary referral hospitals in Australia was performed . Each participant completed the  Kidney Disease Quality of Life ( KDQoL ™ -36 ) question naire , which is comprised of two composite measures of physical and mental health and 3 kidney disease specific subscales with possible scores ranging from 0 to 100 with higher values indicating better HRQoL. Demographic and clinical data were also collected . Regression analyses were performed to determine the relationship between HRQoL and potential predictor factors . Results A total of 308 patients were studied with a mean age of 66.9 ( SD = 11.0 ) years and 70 % were males . Mean scores for the physical composite summary , mental composite summary , symptom/problem list , effects of kidney disease and burden of kidney disease scales were 35.2 , 47.0 , 73.8 , 72.5 and 59.8 respectively . Younger age was associated with lower scores in all subscales except for the physical composite summary . Female gender , obese or normal weight rather than overweight , and smoking were all associated with lower scores in one or more subscales . Scores were progressively lower with more advanced stage of CKD ( p<0.05 ) in all subscales except for the mental composite summary . Conclusion In patients with diabetes and CKD , younger age was associated with lower scores in all HRQoL subscales except the physical composite summary and female gender , obese or normal weight and more advanced stages of CKD were associated with lower scores in one or more subscales . Identifying these factors will inform the timely implementation of interventions to improve the quality of life of these patients Context Can self-management interventions help improve blood pressure control in hypertensive patients ? Contribution In this trial , 636 patients with hypertension were r and omly assigned to receive usual care ; a telephone-delivered , nurse-administered behavioral self-management intervention ; home blood pressure self-monitoring ; or both of the latter 2 interventions . Compared with usual care , the adjusted improvement in the proportion of patients with blood pressure control at 24 months was 4.3 % for the behavioral intervention group , 7.6 % for the blood pressure monitoring group , and 11.0 % for the combined intervention group . Caution Patients were recruited from 2 university-affiliated clinics , and most ( 73 % ) already had reasonable blood pressure control at trial entry . The Editors Although multiple treatment options are available for hypertension , only one third of U.S. patients with hypertension have their blood pressure ( BP ) under effective control ( 1 ) . Home BP monitoring is a potentially important aspect of successful hypertension management ( 2 ) . Adopting a healthy lifestyle and adhering to provider recommendations are also important in managing hypertension . Few educational and BP monitoring studies have provided long-term follow-up ( > 12 months ) or implemented a multidimensional intervention that is tailored to patients ' needs and delivered by telephone ( 3 ) . A tailored telephone behavioral intervention and home BP monitoring may be a cost-effective method for improving BP outcomes ( 4 ) . We compared the effectiveness of BP self-monitoring , a tailored , nurse-administered behavior self-management intervention , and a combination of the 2 interventions with that of usual care . Methods The study was approved by the Duke University Institutional Review Board , and all patients provided written informed consent . Setting and Participants Recruitment occurred from May 2004 to December 2005 , with follow-up from November 2004 to January 2008 . Potentially eligible study patients were identified through weekly data extraction s from the billing and appointment data base for 2 Duke University Health System primary care clinics . Patients were cared for by 7 faculty general internists in 1 clinic and 85 residents under the supervision of faculty at the other clinic . Initial inclusion criteria were hypertension diagnosed at least 12 months before the data extraction date ( International Classification of Diseases , 9th revision , codes 401.0 , 401.1 , or 401.9 ) , enrollment with a primary care physician at the included clinic for at least 12 months before data extraction , self-report of current antihypertensive medication use , a scheduled appointment with a nonlaboratory primary care provider during the next 30 days , and residence in 1 of 32 specified ZIP codes in the areas around Duke University Health System . Exclusion criteria applied before r and omization were a diagnosis of dementia , Parkinson disease , atrial fibrillation , or end-stage renal disease ; patient of a study investigator or physician not expected to remain at the practice during the entire study period ; resident in nursing home or receiving home health care ; hospitalization for stroke or heart attack , surgery for blocked arteries , or diagnosis of metastatic cancer in the previous 3 months ; poor vision or difficulty hearing on the telephone ; difficulty underst and ing English on the telephone ; participant in another BP study ; spouse participating in current study ; arm circumference greater than 17 inches and wrist circumference greater than 8.5 inches ; pregnant or planning to become pregnant in the next 2 years ; or not receiving most medical care from Duke clinics . Patients also were excluded after r and omization because they were no longer receiving medical care at the Duke clinics , had initiated dialysis , had received an organ transplant in the previous 6 months , resided in a nursing home or receiving home health care , had no telephone , or received a diagnosis of pulmonary hypertension in the previous 6 months . The study team mailed qualifying patients a letter from the patient 's primary care provider that gave information about the study and stated that the study team may contact them to participate . Research assistants made weekly screening telephone calls to patients from a r and omly ordered list of eligible patients with upcoming clinic appointments . Figure 1 shows the flow of participants in the study . Overall , 2060 invitation letters were mailed to patients . Research assistants attempted to contact 1728 potential participants by telephone . Six hundred fifty-six patients were enrolled and consented to participate ; the remaining 1072 were not enrolled for various reasons . Twenty additional patients were excluded at the time of the baseline interview . Figure 1 . Study flow diagram . BP = blood pressure . * No longer receiving care at Duke clinics , receiving dialysis , received an organ transplant , residing in a nursing home or receiving home health care , had no telephone , or had pulmonary hypertension . R and omization and Intervention The 636 eligible patients were r and omly assigned to receive usual care , a tailored behavioral telephone intervention , home BP monitoring , or the behavioral intervention plus BP monitoring . In a 22 design , r and omization was stratified at baseline by enrollment site ( 2 primary care clinics ) and health literacy status , as determined by using the Rapid Estimate of Adult Literacy in Medicine ( 5 ) ( low literacy , score of 0 to 60 [ 9th- grade level or less ] [ 6 ] , vs. adequate literacy , score of 61 to 66 [ greater than 9th- grade level ] [ 7 ] ) . Consecutively numbered envelopes were used to r and omly assign patients in each stratum . R and omization blocks of 16 were computer generated by the study statistician and used to ensure ongoing balanced enrollment across the 4 groups . The research assistants were blinded to block size , and patient r and omization sequences were maintained by the study statistician in a separate office from the clinics . At completion of the baseline interview , a research assistant opened an envelope and disclosed the patient 's r and omization status . Participants were reimbursed $ 25 for the baseline visit and for each of the 4 subsequent 6-month BP measurement visits ( $ 125 total ) . Usual Care Patients assigned to usual care received hypertension care from their primary care provider . They were not provided home BP monitors and did not have access to the nurse-administered behavioral intervention . They underwent the same 6-month outcome assessment measurements as the other groups . Tailored Behavioral Self-management Intervention Patient factors targeted in the behavioral intervention included perceived risk for hypertension , memory , literacy , social support , patients ' relationships with their health care providers , and side effects of antihypertension medication . In addition , the intervention focused on improving  adherence to the Dietary Approaches to Stop Hypertension ( DASH ) dietary pattern  ( 811 ) ,  weight loss  ( 12 , 13 ) ,  reduced sodium intake  ( 13 , 14 ) ,  regular moderate-intensity physical activity  ( 15 , 16 ) ,  smoking cessation  , and moderation of alcohol intake  ( 17 ) . The intervention was delivered by 1 nurse during bimonthly telephone calls . All information was presented in an easily understood format with a FleschKincaid readability score of less than 9th grade ( 18 ) . Each encounter included a core group of modules potentially implemented during each call ( for example , medication and side effects ) plus additional modules activated at specific intervals ( for example , diet and social support ) ( 19 ) . Home BP Monitoring Intervention Patients assigned to home BP monitoring received an Omron HEM 773AC arm monitor ( OMRON Healthcare , Bannockburn , Illinois ) if arm circumference was 17 inches or less or an Omron HEM 637 wrist monitor if arm circumference was greater than 17 inches and wrist circumference was less than 8.5 inches . Two research assistants trained patients in proper use of the home BP devices . At each 6-month assessment , patients were retrained if their BP assessment procedure was incorrect . Patients were asked to measure their BP 3 times weekly on 3 separate days , at the same time of day , and record their values in a log . Patients were asked to mail their logs in every 2 months by using study -provided , preaddressed , stamped envelopes . Combined Intervention Patients assigned to the combined intervention received a home BP monitor , training on its use , and the behavioral self-management intervention . The nurse did not examine home BP values and did not use the home BP values to adjust the intervention . Outcomes and Measurements Baseline Measurement Patient demographic information and diagnosis of diabetes were obtained from patients during a face-to-face baseline interview . Inadequate income was assessed by asking patients to report whether they had enough money to pay bills only by cutting back on things or had difficulty paying bills ( 20 ) . Health literacy was evaluated as a dichotomous variable ( 7 ) . Body weight abstract ed from the medical record and self-reported height were used to calculate body mass index . Study Outcomes : BP Control and Systolic and Diastolic BP The primary outcome was the proportion of participants with adequate BP control at each study time point ( baseline and 6 , 12 , 18 , and 24 months ) . Blood pressure control was defined as systolic BP less than 140 mm Hg and diastolic BP less than 90 mm Hg for patients without diabetes , and systolic BP less than 130 mm Hg and diastolic BP less than 80 mm Hg for patients with diabetes ( 21 ) . Secondary outcomes were systolic and diastolic BP at each time point over 24 months . At each time point , a research assistant who was blinded to the patient 's group assignment obtained 2 BP measurements with a digital sphygmomanometer ( BPTRU Automated Non-invasive BP monitor , Model BPM-100 , BpTRU Medical Devices Headquarters , Coquitlam , British Columbia , Canada ) ; the first was obtained after patients were BACKGROUND Previous studies have demonstrated that multidisciplinary pre-dialysis education and team care may slow the decline in renal function for chronic kidney disease ( CKD ) . Our study compared clinical outcomes of CKD patients between multidisciplinary care ( MDC ) and usual care in Taiwan . METHODS In this 3-year prospect i ve cohort study from 2008 to 2010 , we recruited 1056 CKD subjects , aged 20 - 80 years , from five hospitals , who received either MDC or usual care , had an estimated glomerular filtration rate ( eGFR ) < 60 mL/min , were matched one to one with the propensity score including gender , age , eGFR and co-morbidity diseases . The MDC team was under-cared based on NKF K/DOQI clinical practice guidelines and the Taiwanese pre-end-stage renal disease ( ESRD ) care program . The incidence of progression to ESRD ( initiation of dialysis ) and mortality was compared between two groups . We also monitored blood pressure control , the rate of renal function decline , lipid profile , hematocrit and mineral bone disease control .  RESULTS Participants were prone to be male ( 64.8 % ) with a mean age of 65.1 years and 33.1 months of mean follow-up . The MDC group had higher prescription rates of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker ( ACEI/ARB ) , phosphate binder , vitamin D3 , uric acid lower agents and erythropoietin-stimulating therapy and better control in secondary hyperparathyroidism . The decline of renal function in advanced stage CKD IV and V was also slower in the MDC group ( -5.1 versus -7.3 mL/min , P = 0.01 ) . The use of temporary dialysis catheter was higher in the usual care group , and CKD patients under MDC intervention exhibited a greater willingness to choose peritoneal dialysis modality . A Cox regression revealed that the MDC group was associated with a 40 % reduction in the risk of hospitalization due to infection , and a 51 % reduction in patient mortality , but a 68 % increase in the risk of initiation dialysis when compared with the usual care group . CONCLUSIONS MDC patients were found to have more effective medication prescription according to K/DOQI guidelines and slower renal function declines in advanced/late-stage CKD . After MDC intervention , CKD patients had a better survival rate and were more likely to initiate renal replacement therapy ( RRT ) instead of mortality M eeting the complex needs of patients with chronic illness or impairment is the single greatest challenge facing organized medical practice . Usual care is not doing the job ; dozens of surveys and audits have revealed that sizable proportions of chronically ill patients are not receiving effective therapy , have poor disease con- trol , and are unhappy with their care ( 1 ) . Results of r and omized trials also show that effective disease management programs can achieve substantially better outcomes than usual care , the control intervention . These trials , along with the ideas and efforts for improvement discussed in this issue , show that we can improve care and outcomes . As the articles suggest , these improvements will not come easily . If we are to improve care for most patients with chronic illness , the evidence strongly suggests that we reshape our ambulatory care systems for this purpose . Pri- mary care practice was largely design ed to provide ready access and care to patients with acute , varied problems , with an emphasis on triage and patient flow ; short appointments ; diagnosis and treatment of symptoms and signs ; reliance on laborato- ry investigations and prescriptions ; brief , didactic patient education ; and patient- initiated follow-up . Patients and families struggling with chronic illness have differ- ent needs , and these needs are unlikely to be met by an acute care organization and culture . They require planned , regular interactions with their caregivers , with a focus on function and prevention of exacerbations and complications . This interac- tion includes systematic assessment s , attention to treatment guidelines , and behav- iorally sophisticated support for the patient 's role as self-manager . These interactions must be linked through time by clinical ly relevant information systems and continu- ing follow-up initiated by the medical practice . Comprehensive System Background Despite evidence that optimal care for diabetes can result in reduced complications and improved economic outcomes , such care is often not achieved . The Vermont Diabetes Information System ( VDIS ) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes . Purpose To develop and evaluate a regional decision support system for patients with diabetes . Methods R and omized trial of an information system with clustering at the practice level . Ten percent r and om sub sample of patients selected for a home interview . Subject and setting includes 10 hospitals , 121 primary care providers , and 7348 patients in 55 Vermont and New York primary care practice s. Results We report on the study design and baseline characteristics of the population . Patients have a mean age of 63 years and a mean glycosolated hemoglobin A1C of 7.1 % . Sixty percent of the population has excellent glycemic control ( A1C , 7 % ) ; 45 % have excellent lipid control ( serum LDL-cholesterol,100 mg /dL and serum triglycerides,400 mg/dL ) . Twenty-five percent have excellent blood pressure control ( , 130/80 mm Hg ) . These results compare favorably to recent national reports . However , only 8 % are in optimal control for all three of hyperglycemia , lipids and blood pressure . Conclusions Our experience to date indicates that a low cost decision support and information system based on the Chronic Care Model is feasible in primary care practice s that lack sophisticated electronic information systems . VDIS is well accepted by patients , providers and laboratory staff . If proven beneficial in a rigorous , r and omized , controlled evaluation , the intervention could be widely disseminated to practice s across America and the world with a substantial impact on the outcomes and costs of diabetes . It could also be adapted to other chronic conditions . We anticipate the results of the study will be available in 2006 AIMS The aim of this study was to test the feasibility and impact of an intervention consisting of self-monitored blood pressure , medicine review , a Digital Versatile Disc , and motivational interviewing telephone calls to help people with diabetes and kidney disease improve their blood pressure control and adherence to prescribed medications . BACKGROUND People with co-existing diabetes , kidney disease and hypertension require multiple medications to manage their health . About 50 % of people are non-adherent to their prescribed medications with non-adherence increasing in the presence of chronic conditions . DESIGN R and omized controlled trial . METHODS Patients aged ≥18 years with diabetes , chronic kidney disease and systolic hypertension were recruited from nephrology and diabetes out patients ' clinics of an Australian metropolitan hospital between 2008 - 2009 . Participants were r and omly allocated on a 1:1 basis to one of two groups in a r and omized controlled trial : the intervention delivered over 3 months ( n = 39 ) and usual care ( n = 41 ) , with follow-up at 3 , 6 and 9 months postintervention . People collecting data and assessing outcomes were blinded to group assignment . RESULTS Seventy-five participants completed the study . The intervention was acceptable and feasible for this cohort . There were no statistically significant differences between groups , although the mean systolic blood pressure reduction in the intervention group ( n = 36 ) was -6·9 mmHg 95 % CI ( -13·8 , -0·02 ) at 9 months postintervention . CONCLUSION The study was feasible and statistically significant differences may be determinable in a larger sample to overcome the variability between groups , paying attention to recommendations for further research . TRIAL REGISTRATION The trial was prospect ively registered with the Australian and New Zeal and Clinical Trials Register ( ACTRN12607000044426 ) BACKGROUND R and omized trials can show whether a treatment effect is statistically significant and can describe the size of the effect . There are , however , no vali date d methods available for establishing the clinical relevance of these outcomes . Recently , it was proposed that a st and ardized mean difference ( SMD ) of 0.50 be used as cutoff for clinical relevance in the treatment of depression . METHODS We explore what the effect size means and why the size of an effect has little bearing on its clinical relevance . We will also examine how the " minimally important difference , " as seen from the patient perspective , may be helpful in deciding where the cutoff for clinical relevance should be placed for a given condition . RESULTS Effect sizes in itself can not give an indication of the clinical relevance of an intervention because the outcome itself determines the clinical relevance and not only the size of the effects . The " minimal important difference " ( MID ) could be used as a starting point for pinpointing the cutoff for clinical relevance . A first , rough attempt to implement this approach for depression result ed in a tentative clinical relevance cutoff of SMD = 0.24 . Using this cutoff , psychotherapy , pharmacotherapy , and combined treatment have effect sizes above this cutoff . DISCUSSION Statistical outcomes can not be equated with clinical relevance . The " MID " may be used for pinpointing the cutoff for clinical relevance , but more work in this area is needed
Background Self-management support interventions may potentially delay kidney function decline and associated complications in patients with comorbid diabetes and chronic kidney disease .
However , the effectiveness of these interventions remains unclear .
We investigated the effectiveness of current self-management support interventions and their specific components and elements in improving patient outcomes .