HEART: heart exercise and remote technologies: A randomized controlled trial study protocol A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders Rationale and design of the Medication adherence Improvement Support App For Engagement-Blood Pressure (MedISAFE-BP) trial. mHealth intervention to support asthma self-management in adolescents: the ADAPT study Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care. A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol The effectiveness of daily SMS reminders in pharmaceutical care of older adults on improving patients’ adherence to antihypertensive medication (SPPA): study protocol for a randomized controlled trial Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial Medication Adherence and the Risk of Cardiovascular Mortality and Hospitalization Among Patients With Newly Prescribed Antihypertensive Medications
Background Cardiovascular disease ( CVD ) is the leading cause of death worldwide . Cardiac rehabilitation ( CR ) is aim ed at improving health behaviors to slow or reverse the progression of CVD disease . Exercise is a central element of CR . Technologies such as mobile phones and the Internet ( mHealth ) offer potential to overcome many of the psychological , physical , and geographical barriers that have been associated with lack of participation in exercise-based CR . We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD . This paper outlines the rationale and methods of the trial . Methods A single-blinded parallel two-arm r and omized controlled trial is being conducted . A total of 170 people will be r and omized at 1:1 ratio either to receive a  mHealth CR program  or usual care .  Participants are identified by CR nurses from two metropolitan hospitals in Auckl and , New Zeal and through outpatient clinics and existing data bases . Consenting participants are contacted to attend a baseline assessment . The intervention consists of a theory-based , personalized , automated package of text and video message components via participants ' mobile phones and the Internet to increase exercise behavior , delivered over six months . The control group will continue with usual CR . Data collection occurs at baseline and 24 weeks ( post-intervention ) . The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks . Secondary outcomes include post-intervention measures on self-reported physical activity ( IPAQ ) , cardiovascular risk factors ( systolic blood pressure , weight , and waist to hip ratio ) , health related quality of life ( SF-36 ) , and cost-effectiveness . Discussion This manuscript presents the protocol for a r and omized controlled trial of a mHealth exercise-based CR program . Results of this trial will provide much needed information about physical and psychological well-being , and cost-effectiveness of an automated telecommunication intervention . If effective , this intervention has enormous potential to improve the delivery of CR and could easily be scaled up to be delivered nationally ( and internationally ) in a very short time , enhancing the translational aspect of this research . It also has potential to extend to comprehensive CR ( nutrition advice , smoking cessation , medication adherence).Trial Registration Background Nonadherence to prescribed medication regimens is a substantial barrier to the pharmacological management of alcohol use disorders . The availability of low-cost , sustainable interventions that maximize medication adherence would likely lead to improved treatment outcomes . Mobile health ( mHealth ) technologies are increasingly being adopted as a method of delivering behavioral health interventions and represent a promising tool for adherence interventions . We are evaluating a cell-phone – based intervention called AGATE that seeks to enhance adherence with regular text-messaging . Methods / Design A r and omized controlled effectiveness trial in the context of an eight-week open label naltrexone efficacy trial delivered in a naturalistic clinical setting . Treatment-seeking heavy drinkers ( N = 105 ) are currently being recruited and r and omly assigned to the AGATE intervention or a control condition .  Daily measures of alcohol use and medication side effects are being recorded via cell phone in both conditions . Additionally , participants r and omized to the AGATE condition receive medication reminders via SMS text message according to a schedule that adjusts according to their level of adherence . Discussion Results from this trial will provide initial information about the feasibility and efficacy of mHealth interventions for improving adherence to alcohol pharmacotherapies . Trial Registration NCT01349985 BACKGROUND Hypertension is a major contributor to the health and economic burden imposed by stroke , heart disease , and renal insufficiency . Antihypertensives can prevent many of the harmful effects of elevated blood pressure , but medication nonadherence is a known barrier to the effectiveness of these treatments . Smartphone-based applications that remind patients to take their medications , provide education , and allow for social interactions between individuals with similar health concerns have been widely advocated as a strategy to improve adherence but have not been subject to rigorous testing . METHODS / DESIGN The MedISAFE-BP study is a prospect i ve , r and omized control trial design ed to evaluate the impact on blood pressure and medication adherence of an mhealth application ( Medisafe ) .  Four hundred thirteen patients with uncontrolled hypertension have been enrolled and r and omized in a 1:1 fashion to usual care or to the use of the Medisafe mhealth platform  . Patients will be followed up for 12 weeks and the trial 's co- primary outcomes will be change in systolic blood pressure and self-reported medication adherence . DISCUSSION The MedISAFE-BP trial is the first study to rigorously evaluate an mhealth application 's effect on blood pressure and medication adherence . The results will inform the potential effectiveness of this simple system in improving cardiovascular disease risk factors and clinical outcomes Purpose Poor medication adherence in adolescents with asthma results in poorly controlled disease and increased morbidity . The aim of the ADolescent Adherence Patient Tool ( ADAPT ) study is to develop an mHealth intervention to support self-management and to evaluate the effectiveness in improving medication adherence and asthma control . Intervention The ADAPT intervention consists of an interactive smartphone application ( app ) connected to a desktop application for health care providers , in this study , the community pharmacist . The app contains several functions to improve adherence as follows : 1 ) a question naire function to rate asthma symptoms and monitor these over time ; 2 ) short movie clips with medication and disease information ; 3 ) a medication reminder ; 4 ) a chat function with peers ; and 5 ) a chat function with the pharmacist . The pharmacist receives data from the patient ’s app through the desktop application , which enables the pharmacist to send information and feedback to the patient . Study design The ADAPT intervention is tested in a community pharmacy-based cluster r and omized controlled trial in the Netherl and s , aim ing to include 352 adolescents with asthma . The main outcome is adherence , measured by patient ’s self-report and refill adherence calculated from pharmacy dispensing records . In addition , asthma control , illness perceptions , medication beliefs , and asthma-related quality of life are measured . Conclusion This study will provide in-depth knowledge on the effectiveness of an mHealth intervention to support asthma self-management in adolescents . These insights will also be useful for adolescents with other chronic diseases ABSTRACT Background : Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India . Innovative approaches such as clinical decision support ( CDS ) software could play a major role in improving the quality of hypertension/diabetes care in primary care setting s. Objective : To describe the steps and processes in the development of mWellcare , a complex intervention based on mobile health ( mHealth ) technology . Methods : The Medical Research Council framework was used to develop mWellcare in four steps : ( 1 ) identify gaps in usual care through literature review and health facility assessment s ; ( 2 ) identify the components of the intervention through discussion s and consultations with experts ; ( 3 ) develop intervention ( clinical algorithms and mHealth system ) ; and ( 4 ) evaluate acceptability and feasibility through pilot testing in five community health centers . Results : Lack of evidence -based , integrated , and systematic management of chronic conditions were major gaps identified . Experts in information technology , clinical fields , and public health professionals identified intervention components to address these gaps . Thereafter , clinical algorithm context ualized to primary care setting s were prepared and the mWellcare intervention was developed . During the 2-month pilot , 631 patients diagnosed with hypertension and /or diabetes were registered , with a follow-up rate of 36.2 % . The major barrier was resistance to follow mWellcare recommended patient workflow , and to overcome it , we emphasized onsite training and orientation program to cover all health care team member in each CHC . Conclusion : A pilot-tested mWellcare intervention is an mHealth system with important components , i.e. integrated management of chronic conditions , evidence -based CDS , longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit , which will be used by nurses at primary health care setting s in India . The effectiveness and cost-effectiveness of the intervention will be tested through a cluster r and omized trial ( trial registration number NCT02480062 ) Background Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities ( eg , hypertension , diabetes ) . These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients ’ physiological data . This technology is also relatively inexpensive , has an intuitive interface , and provides the capability for real-time personalized feedback to help motivate patient self-efficacy . Automated summary reports of patients ’ adherence and blood pressure can easily be uploaded to providers ’ networks helping reduce clinical inertia by reducing regimen alteration time . Objective The aim of this study was to assess the feasibility , acceptability , and preliminary outcomes of a prototype mobile health ( mHealth ) medication and blood pressure ( BP ) self-management system for kidney transplant patients with uncontrolled hypertension . Methods A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design . The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback . A 3-month proof-of-concept r and omized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray . Participants r and omized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging . Controls received st and ard of care and their adherence continued to be monitored with the medication tray reminders turned off . Providers received weekly summary reports of patient medication adherence and BP readings . Results Participation and retention rates were 41/55 ( 75 % ) and 31/34 ( 91 % ) , respectively . The prototype system appears to be safe , highly acceptable , and useful to patients and providers . Compared to the st and ard care control group ( SC ) , the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations . Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the st and ard care group ( 7 adjustments in 5 patients versus 3 adjustments in 3 patients ) during the 3-month trial based on the information provided in the weekly reports . Conclusions These data support the acceptability and feasibility of the prototype mHealth system . Further trials with larger sample sizes and additional biomarkers ( eg , whole blood medication levels ) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control  after kidney transplantation over longer time periods . Trial Registration Clinical trials.gov NCT01859273 ; http:// clinical trials.gov/ct2/show/NCT01859273 ( Archived by WebCite at http://www.webcitation.org/6IqfCa3A3 ) Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : BACKGROUND Cardiovascular disease ( CVD ) is the leading cause of death , and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zeal and . CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin , blood pressure lowering and lipid lowering therapies . However , prescribing and adherence rates are low and CVD events remain high . AIM To assess whether a medication strategy using a fixed dose combination pill ( ' polypill ' ) could improve prescribing and adherence to recommended medications , lower blood pressure and improve lipids compared with current care over 12 months . METHODS IMProving Adherence using Combination Therapy ( IMPACT ) is an open-label r and omised controlled trial comparing a once-daily polypill containing four preventive medications with usual care .  Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled , including 300 Māori . Participants are identified , enrolled and prescribed either the polypill or current medications at their usual primary health care practice , with medications ( including the polypill ) dispensed through local community pharmacies . The polypill contains 75 mg aspirin , 40 mg simvastatin , 10 mg lisinopril and either 12.5 mg hydrochlorothiazide or 50 mg atenolol . Primary outcomes are adherence to guidelines -recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months . Secondary outcomes include other lipids , medication dispensing , barriers to adherence , CVD and other serious adverse events , quality of life and prescriber acceptability . The trial is registered with the Australian New Zeal and Clinical Trial Registry ( ACTRN12606000067572 ) Introduction Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk . In this project , we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice . Consumer Navigation of Electronic Cardiovascular Tools ( CONNECT ) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Isl and er and non-indigenous adults , recruited through primary care , at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care . Methods and analysis R and omised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk . The trial will be augmented by formal economic and process evaluations to assess acceptability , equity and cost-effectiveness of the intervention . The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management . The programme is electronically integrated with the primary care provider 's software and will include interactive smart phone and Internet platforms . The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline -recommended blood pressure ( BP ) and cholesterol targets . Secondary outcomes include change in mean BP and fasting cholesterol levels , proportion meeting BP and cholesterol targets separately , self-efficacy , health literacy , self-reported point prevalence abstinence in smoking , body mass index and waist circumference , self-reported physical activity and self-reported medication adherence . Ethics and dissemination Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences Clinical Trials registration number ACTRN12613000715774 Background Despite a variety of efficient and cost-effective antihypertensive medication , hypertension remains a serious health and economic burden . High consumption of cardiovascular drugs in the Slovak Republic does result neither in better hypertension control nor in significant decrease in cardiovascular mortality . At the same time , Slovakia has alarmingly low patients ’ adherence to medication intake . Studies have shown the efficiency of short messaging service ( SMS ) reminders to improve patients ’ adherence and health outcomes at low costs . Since SMS is popular among Slovaks , this approach may be feasible also in Slovakia . The primary objective is to assess if daily SMS reminders of antihypertensive medication intake provided by pharmacists in addition to the st and ard pharmaceutical care increase the proportion of adherent older hypertensive ambulatory patients . Methods The SPPA trial is a pragmatic r and omized parallel group ( 1:1 ) trial in 300 older hypertensive patients carried out in community pharmacies in Slovakia . Trial pharmacies will be selected from all main regions of Slovakia . Trial intervention comprises daily personalized SMS reminders of medication intake embedded into usual pharmaceutical practice . The primary outcome is a combined adherence endpoint consisting of subjective self-reported medication adherence via the eight-item Morisky Medication Adherence Scale ( MMAS-8 ) and objective pill count rate . Secondary outcomes include : change in the MMAS-8 ; comparison of adherence rates using pill count ; change in systolic blood pressure ; and patient satisfaction . Also , direct treatment costs will be evaluated and a cost-effectiveness analysis will be carried out . Discussion The SPPA trial engages community pharmacists and mobile health ( mHealth ) technologies via evidence -based pharmaceutical care to efficiently and cost-effectively addresses current main healthcare challenges : high prevalence of hypertension ; overconsumption of cardiovascular medicines ; low adherence to medication treatment ; and result ing uncontrolled blood pressure . The results may identify new possibilities and capacities in healthcare with low additional costs and high value to patients .Trial registration Clinical Trials.gov , NCT03105687 . Registered on 07 March 2017 Background Mobile technology has the potential to deliver behavior change interventions ( mHealth ) to reduce coronary heart disease ( CHD ) at modest cost . Previous studies have focused on single behaviors ; however , cardiac rehabilitation ( CR ) , a component of CHD self-management , needs to address multiple risk factors . Objective The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program ( Text4Heart ) to improve adherence to recommended lifestyle behaviors ( smoking cessation , physical activity , healthy diet , and nonharmful alcohol use ) in addition to usual care ( traditional CR ) . Methods A 2-arm , parallel , r and omized controlled trial was conducted in New Zeal and adults diagnosed with CHD . Participants were recruited in-hospital and were encouraged to attend center-based CR ( usual care control ) . In addition , the intervention group received a personalized 24-week mHealth program , framed in social cognitive theory , sent by fully automated daily short message service ( SMS ) text messages and a supporting website . The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score ( ≥3 ) at 3 and 6 months . Secondary outcomes included clinical outcomes , medication adherence score , self-efficacy , illness perceptions , and anxiety and /or depression at 6 months . Baseline and 6-month follow-up assessment s ( unblinded ) were conducted in person . Results Eligible patients ( N=123 ) recruited from 2 large metropolitan hospitals were r and omized to the intervention ( n=61 ) or the control ( n=62 ) group . Participants were predominantly male ( 100/123 , 81.3 % ) , New Zeal and European ( 73/123 , 59.3 % ) , with a mean age of 59.5 ( SD 11.1 ) years . A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months ( AOR 2.55 , 95 % CI 1.12 - 5.84 ; P=.03 ) , but not at 6 months ( AOR 1.93 , 95 % CI 0.83 - 4.53 ; P=.13 ) . The intervention group reported significantly greater medication adherence score ( mean difference : 0.58 , 95 % CI 0.19 - 0.97 ; P=.004 ) . The majority of intervention participants reported reading all their text messages ( 52/61 , 85 % ) . The number of visits to the website per person ranged from zero to 100 ( median 3 ) over the 6-month intervention period . Conclusions A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zeal and adults with CHD compared to usual care alone . The effect was not sustained to the end of the 6-month intervention . A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events . Trial Registration ACTRN 12613000901707 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=364758&is Review = true ( Archived by WebCite at http://www.webcitation.org/6c4qhcHKt The importance of adherence to antihypertensive treatments for the prevention of cardiovascular disease has not been well eluci date d. This study evaluated the effect of antihypertensive medication adherence on specific cardiovascular disease mortality ( ischemic heart disease [ IHD ] , cerebral hemorrhage , and cerebral infa rct ion ) . Our study used data from a 3 % sample cohort that was r and omly extracted from enrollees of Korean National Health Insurance . Study subjects were aged ≥20 years , were diagnosed with hypertension , and started newly prescribed antihypertensive medication in 2003 to 2004 . Adherence to antihypertensive medication was estimated as the cumulative medication adherence . Subjects were divided into good ( cumulative medication adherence , ≥80 % ) , intermediate ( cumulative medication adherence , 50%–80 % ) , and poor ( cumulative medication adherence , < 50 % ) adherence groups . We used time-dependent Cox proportional hazards models to evaluate the association between medication adherence and health outcomes . Among 33 728 eligible subjects , 670 ( 1.99 % )  died of coronary heart disease or stroke during follow-up . Patients with poor medication adherence had worse mortality from IHD ( hazard ratio , 1.64 ; 95 % confidence interval , 1.16–2.31 ; P for trend=0.005 ) , cerebral hemorrhage ( hazard ratio , 2.19 ; 95 % confidence interval , 1.28–3.77 ; P for trend=0.004 ) , and cerebral infa rct ion ( hazard ratio , 1.92 ; 95 % confidence interval , 1.25–2.96 ; P for trend=0.003 ) than those with good adherence . The estimated hazard ratios of hospitalization for cardiovascular disease were consistent with the mortality end point . Poor medication adherence was associated with higher mortality and a greater risk of hospitalization for specific cardiovascular diseases , emphasizing the importance of a monitoring system and strategies to improve medication adherence in clinical practice
Limitations of trials included small sample sizes , short duration of follow-up , self-reported outcomes , and insufficient assessment of unintended harms and financial implication s. Current evidence suggests that mHealth tools can improve medication adherence in patients with cardiovascular diseases .
Cardiovascular disease is a leading cause of morbidity and mortality worldwide , and a key barrier to improved outcomes is medication non-adherence .
The aim of this study is to review the role of mobile health ( mHealth ) tools for improving medication adherence in patients with cardiovascular disease .