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 Abandoned Acid? Understanding Adherence to Bisphosphonate Medications for the Prevention of Osteoporosis among Older Women: A Qualitative Longitudinal Study Intramyocardial injection of autologous bone marrow mononuclear cells for patients with chronic ischemic heart disease and left ventricular dysfunction (First Mononuclear Cells injected in the US [FOCUS]): Rationale and design. Improving adherence to cardiovascular disease medications with information technology. Strategies to improve adherence with medications in chronic, ‘silent’ diseases representing high cardiovascular risk A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Increasing the Detection and Response to Adherence Problems with Cardiovascular Medication in Primary Care through Computerized Drug Management Systems: A Randomized Controlled Trial Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE): rationale and design of a randomised controlled trial of a cardiovascular preventive polypill-based strategy in India and Europe Self-reported medication adherence and cardiovascular events in patients with stable coronary heart disease: the heart and soul study. Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) – study protocol for a randomized controlled trial Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Novel Mobile Phone-Based Intervention: Study Design of a Randomized Controlled Trial Design Considerations in Development of a Mobile Health Intervention Program: The TEXT ME and TEXTMEDS Experience
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 Background There is significant morbidity and mortality caused by the complications of osteoporosis , for which ageing is the greatest epidemiological risk factor . Preventive medications to delay osteoporosis are available , but little is known about motivators to adhere to these in the context of a symptomless condition with evidence based on screening results . Aim To describe key perceptions that influence older women 's adherence and persistence with prescribed medication when identified to be at a higher than average risk of fracture . Design of Study A longitudinal qualitative study embedded within a multi-centre trial exploring the effectiveness of screening for prevention of fractures . Setting Primary care , Norfolk . United Kingdom Methods Thirty older women aged 70–85 years of age who were offered preventive medication for osteoporosis and agreed to undertake two interviews  at 6 and 24 months post-first prescription . Results There were no overall predictors of adherence which varied markedly over time . Participants ' perceptions and motivations to persist with medication were influenced by six core themes : underst and ing adherence and non-adherence , motivations and self-care , appraising and prioritising risk , anticipating and managing side effects , problems of underst and ing , and decision making around medication . Those engaged with supportive professionals could better tolerate and overcome barriers such as side-effects . Conclusions Many issues are raised following screening in a cohort of women who have not previously sought advice about their bone health . Adherence to preventive medication for osteoporosis is complex and multifaceted . Individual participant underst and ing , choice , risk and perceived need all interact to produce unpredictable patterns of usage and acceptability . There are clear implication s for practice and health professionals should not assume adherence in any older women prescribed medication for the prevention of osteoporosis . The beliefs and motivations of participants and their healthcare providers regarding the need to establish acceptable medication regimes is key to promoting and sustaining adherence BACKGROUND The increasing worldwide prevalence of coronary artery disease ( CAD ) continues to challenge the medical community . Management options include medical and revascularization therapy . Despite advances in these methods , CAD is a leading cause of recurrent ischemia and heart failure , posing significant morbidity and mortality risks along with increasing health costs in a large patient population worldwide . TRIAL DESIGN The Cardiovascular Cell Therapy Research Network ( CCTRN ) was established by the National Institutes of Health to investigate the role of cell therapy in the treatment of chronic cardiovascular disease . FOCUS is a CCTRN- design ed r and omized , phase II , placebo-controlled clinical trial that will assess the effect of autologous bone marrow mononuclear cells delivered transendocardially to patients with left ventricular ( LV ) dysfunction and symptomatic heart failure or angina . All patients need to have limiting ischemia by reversible ischemia on single-photon emission computed tomography assessment . RESULTS After thoughtful consideration of both statistical and clinical principles , we will recruit 87 patients ( 58 cell treated and 29 placebo )  to receive either bone marrow-derived stem cells or placebo .  Myocardial perfusion , LV contractile performance , and maximal oxygen consumption are the primary outcome measures . CONCLUSIONS The design ed clinical trial will provide a sound assessment of the effect of autologous bone marrow mononuclear cells in improving blood flow and contractile function of the heart . The target population is patients with CAD and LV dysfunction with limiting angina or symptomatic heat failure . Patient safety is a central concern of the CCTRN , and patients will be followed for at least 5 years OBJECTIVES Evaluate the utility of 2 electronic medical record (EMR)-linked , automated phone reminder interventions for improving adherence to cardiovascular disease medications . STUDY DESIGN A 1-year , parallel arm , pragmatic clinical trial in which 21,752 adults were r and omized to receive either usual care ( UC ) or 1 of 2 interventions in the form of interactive voice recognition calls-regular ( IVR ) or enhanced ( IVR+ ) . The interventions used automated phone reminders to increase adherence to cardiovascular disease medications . The primary outcome was medication adherence ; blood pressure and lipid levels were secondary outcomes . METHODS The study took place in 3 large health maintenance organizations . We enrolled participants who were 40 years or older , had diabetes mellitus or atherosclerotic cardiovascular disease , and were suboptimally adherent .  IVR participants received automated phone calls when they were due or overdue for a refill . IVR+ participants received these phone calls , plus personalized reminder letters , live outreach calls , EMR-based feedback to their primary care providers , and additional mailed material s. RESULTS Both interventions significantly increased adherence to statins and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEIs/ARBs ) compared with UC ( 1.6 to 3.7 percentage points ) . Adherence to ACEIs/ARBs was also significantly higher for IVR+ relative to IVR participants . These differences persisted across subgroups . Among statin users , IVR+ participants had significantly lower low-density lipoprotein ( LDL ) levels at follow-up compared with UC ( Δ = -1.5 ; 95 % CI , -2.7 to -0.2 mg/dL ) ; this effect was seen mainly in those with baseline LDL levels ≥ 100 mg/dL ( Δ = -3.6 ; 95 % CI , -5.9 to -1.3 mg/dL ) . CONCLUSIONS Technology-based tools , in conjunction with an EMR , can improve adherence to chronic disease medications and measured cardiovascular disease risk factors Given the burden of illness related to diabetes , hypertension and dyslipidemia , it is very important to achieve glycemic control , optimal blood pressure and low-density lipoprotein cholesterol ( LDL-C ) in order to avoid severe long-term complications . Patients ’ adherence with , and persistence to , the treatment regimen is a critical factor in achieving this goal . Medication taking behavior in these chronic , nonsymptomatic ( ‘ silent ’ ) diseases is generally low , although a wide range of results have been reported . The literature has shown that nonadherence to medications is a multidimensional phenomenon ; relating factors can be grouped into the following categories : health system related , social/economic , condition-related , therapy-related and patient-related factors . Although several interventions exist to improve patients ’ medication-taking behavior , none appear to be clearly superior to others . The key steps to improve adherence are to identify individual barriers and to develop patient-specific self-management plans to overcome them ( called ‘ patient-centric ’ approach ) . When developing intervention strategies one should always remember that ‘ one size does not fit all ’ . Well design ed ( but not r and omized ) , observational studies ( for example , patient registries ) may be required with sufficient follow-up periods and multiple adherence measurements in order to advance the field OBJECTIVE Numerous mobile health ( mHealth ) interventions are being developed to aid in management of complex chronic medical conditions . However , the acceptance of mHealth programs by low-income , bilingual population s has not yet been evaluated . The Trial to Examine Text-based mHealth for  Emergency department patients with Diabetes ( TExT-MED ) program is a text message-based mHealth program design ed specifically for re source -poor patients with diabetes . We conducted a prospect i ve proof-of-concept trial to assess satisfaction and preliminary effectiveness of the TExT-MED program . RESEARCH DESIGN AND METHODS A consecutive sample of adult patients in the emergency department with diabetes and a text message-capable mobile phone was enrolled in the TExT-MED program .  Participants received three text messages daily for 3 weeks in English or Spanish in the following domains : educational/motivational , medication reminders , healthy living challenges , diabetes trivia , and links to free diabetes management tools . RESULTS Twenty-three patients with diabetes ( median hemoglobin A1c , 8.9 % ) were enrolled in TExT-MED .  In the week before TExT-MED , 56.5 % of subjects reported eating fruits/vegetables daily versus 83 % after , 43.5 % reported exercising before versus 74 % after , and 74 % reported performing foot checks before versus 85 % after . Self-efficacy , measured by the Diabetes Empowerment Scale-Short Form , improved from 3.9 to 4.2 . Scores on the Morisky Medication Adherence Scale improved more dramatically from 3.5 to 4.75 . Ninety percent of participants indicated they would like to continue the program , and 100 % would recommend the program to family or friends . CONCLUSIONS This pilot trial of the TExT-MED program demonstrated increased healthy behaviors , improved diabetes self-efficacy and medication adherence , and received excellent satisfaction scores in re source -poor , inner city patients with diabetes Background . Adherence with antihypertensive and lipid-lowering therapy is poor , result ing in an almost 2-fold increase in hospitalization . Treatment side effects , cost , and complexity are common reasons for nonadherence , and physicians are often unaware of these potentially modifiable problems . Objective . To determine if a cardiovascular medication tracking and nonadherence alert system , incorporated into a computerized health record system , would increase drug profile review by primary care physicians , increase the likelihood of therapy change , and improve adherence with antihypertensive and lipid-lowering drugs . Methods . There were 2293 primary care patients prescribed lipid-lowering or antihypertensive drugs who were r and omized to the adherence tracking and alert system or active medication list alone  to determine if the intervention increased drug profile review , changes in cardiovascular drug treatment , and refill adherence in the first 6 months . An intention to treat analysis was conducted using generalized estimating equations to account for clustering within physician . Results . Overall , medication adherence was below 80 % for 36.3 % of patients using lipid-lowering drugs and 40.8 % of patients using antihypertensives at the start of the trial . There was a significant increase in drug profile review in the intervention compared to the control group ( 44.5 % v. 35.5 % ; P < 0.001 ) , a nonsignificant increase in drug discontinuations due to side effects ( 2.3 % v. 2.0 % ; P = 0.61 ) , and a reduction in therapy increases ( 28.5 % v. 29.1 % ; P = 0.86 ) . There was no significant change in refill adherence after 6 months of follow-up . Conclusion . An adherence tracking and alert system increases drug review but not therapy changes or adherence in prevalent users of cardiovascular drug treatment . Targeting incident users where adverse treatment effects are more common and combining adherence tracking and alert tools with motivational interventions provided by multidisciplinary primary care teams may improve the effectiveness of the intervention The use of preventive medications in people at high risk of cardiovascular disease is conceptually straightforward , yet in practice the adoption of such measures is disappointingly low , plus there is wide international variation in preventive therapies . Several barriers might explain this shortfall and variation , but the simplicity and economy of a polypill-based strategy might overcome some barriers . The ‘ Use of a Multidrug Pill In Reducing cardiovascular Events ’ ( UMPIRE ) trial assesses whether a polypill strategy ( by combining aspirin , a statin and two blood pressure lowering agents ) would improve adherence to guideline -indicated therapies and would lower both blood pressure and cholesterol , in people with established cardiovascular disease . UMPIRE , running in India and three European countries ( Engl and , Irel and and the Netherl and s ) , is an open , r and omised , controlled trial design ed to include 1000 participants in India and 1000 in Europe , with a followup of 12–24 months . Participants were r and omised to one of two versions of the polypill or relegated to usual care . The primary study outcomes were the self-reported use of aspirin , a statin and at least two blood pressure lowering agents ; as well as changes in blood pressure and cholesterol . Secondary outcomes included : any cardiovascular events , reasons for stopping medications , serious adverse events and perceived changes in quality of life . Interpretation of the study data will be enhanced by health , economic and process-related evaluations . UMPIRE is registered with the European Clinical Trials data base , as EudraCT : 2009 - 016278 - 34 and the Clinical Trials Registry , India as CTRI/2010/091/000250 . The trial was part of the ‘ Single Pill Against Cardiovascular Events ( SPACE ) ’ collaboration , which encompasses the ‘ IMProving Adherence using Combination Therapy ( IMPACT ) ’ and ‘ Kanyini Guidelines Adherence with the Polypill ( Kanyini-GAP ) ’ trials BACKGROUND Nonadherence to physician treatment recommendations is an increasingly recognized cause of adverse outcomes and increased health care costs , particularly among patients with cardiovascular disease . Whether patient self-report can provide an accurate assessment of medication adherence in out patients with stable coronary heart disease is unknown . METHODS We prospect ively evaluated the risk of cardiovascular events associated with self-reported medication nonadherence in 1015 out patients with established coronary heart disease from the Heart and Soul Study . We asked participants a single question : " In the past month , how often did you take your medications as the doctor prescribed ? " Nonadherence was defined as taking medications as prescribed 75 % of the time or less . Cardiovascular events ( coronary heart disease death , myocardial infa rct ion , or stroke ) were identified by review of medical records during 3.9 years of follow-up . We used Cox proportional hazards analysis to determine the risk of adverse cardiovascular events associated with self-reported medication nonadherence . RESULTS Of the 1015 participants , 83 ( 8.2 % ) reported nonadherence to their medications , and 146 ( 14.4 % ) developed cardiovascular events . Nonadherent participants were more likely than adherent participants to develop cardiovascular events during 3.9 years of follow-up ( 22.9 % vs 13.8 % , P = .03 ) . Self-reported nonadherence remained independently predictive of adverse cardiovascular events after adjusting for baseline cardiac disease severity , traditional risk factors , and depressive symptoms ( hazards ratio , 2.3 ; 95 % confidence interval , 1.3 - 4.3 ; P = .006 ) . CONCLUSIONS In out patients with stable coronary heart disease , self-reported medication nonadherence is associated with a greater than 2-fold increased rate of subsequent cardiovascular events . A single question about medication adherence may be a simple and effective method to identify patients at higher risk for adverse cardiovascular events Background Vascular disease , manifesting as myocardial infa rct ion and stroke , is a major cause of morbidity and mortality , especially in low- and middle-income countries . Current estimates are that only one in six patients have good adherence to medications and very few have sufficient health literacy . Our aim is to explore the effectiveness and acceptability of Prescription Interactive Voice Response ( IVR ) Talking Prescriptions ( Talking Rx ) and SMS reminders in increasing medication adherence and health literacy in Pakistani patients with vascular disease . Methods This is a r and omized , controlled , single center trial . Adult participants , with access to a cell phone and a history of vascular disease , taking multiple risk-modifying medications ( inclusive of anti-platelets and statins ) will be selected from cerebrovascular and cardiovascular clinics . They will be r and omized in a 1:1 ratio via a block design to the intervention or the control arm with both groups having access to a helpline number to address their queries in addition to st and ard of care as per institutional guidelines . Participants in the intervention group will also have access to Interactive Voice Response ( IVR ) technology tailored to their respective prescriptions in the native language ( Urdu ) and will have the ability to hear information about their medication dosage , correct use , side effects , mechanism of action and how and why they should use their medication , as many times as they like . Participants in the intervention arm will also receive scheduled SMS messages reminding them to take their medications . The primary outcome measure will be the comparison of the difference in adherence to anti-platelet and statin medication between baseline and at 3-month follow-up in each group measured by the Morisky Medication Adherence Scale . To ascertain the impact of our intervention on health literacy , we will also compare a local content-vali date d and modified version of Test of Health Literacy in Adults ( TOFHLA ) between the intervention and the control arm . We estimate that a sample size of 86 participants in each arm will be able to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 % . Accounting for an attrition rate of 15 % , we plan to enroll 100 participants in each arm ( total study population = 200 ) . We hypothesize that a linguistically tailored health IT intervention based on IVR and SMS will be associated with an improvement in adherence ( to anti-platelet and lipid-lowering medications ) and an improvement in health literacy in Pakistani patients with vascular disease . Discussion This innovative study will provide early data for the feasibility of the use of IT based prescriptions in an lower middle incorme country setting with limited numeracy and literacy skills . Trial registration Clinical Trials.gov : NCT02354040 − 2 February Background The widespread and increasing use of oral anti-cancer medications has been ushered in by a rapidly increasing underst and ing of cancer pathophysiology . Furthermore , their popular ease of administration and potential cost savings has highlighted their central position in the health care system as a whole . These facts have heightened appreciation of the unique challenges associated with the use of oral anti-cancer medications ; especially in the long-term use of these medications and the associated side effects that may impede optimal adherence to their use . Therefore , we developed ChemOtheRapy Assistant , CORA , a personalized mobile phone – based self-management application to help cancer patients on oral anti-cancer medications . Objective Our objective is to evaluate the effect of CORA on adherence to oral anti-cancer medications and other clinical ly relevant outcomes in the management of patients with renal and prostate cancer . Methods The study will be implemented as a 2-parallel group r and omized controlled trial in 104 patients with renal or prostate cancer on oral anti-cancer medications over a 3-month study period . The intervention group will use CORA in addition to usual care for self-management while the control group will continue care as usual .  Medication adherence will be measured objective ly by a Medication Event Monitoring System device and is defined as the percentage of prescribed doses taken . We will also assess the effect of the intervention on cancer-related symptoms measured by the MD And erson Symptom Inventory and unplanned hospital utilizations . Other outcomes that will be measured at study start , midpoint , and endpoint are health-related quality of life , cancer-related fatigue , and anxiety . Group differences in medication adherence will be examined by t tests or by non-parametric Mann-Whitney tests if the data are not normally distributed . Logistic regression will be used to identify potential predictors of adherence . Results We expect to have results for this study before the end of 2016 . Conclusions This novel mobile phone – enabled , multimodal self-management and educational intervention could lead to improvements in clinical outcomes and serve as a foundation for future mHealth research in improving outcomes for patients on oral anti-cancer medications Background Mobile health ( mHealth ) has huge potential to deliver preventative health services . However , there is paucity of literature on theoretical constructs , technical , practical , and regulatory considerations that enable delivery of such services . Objectives The objective of this study was to outline the key considerations in the development of a text message-based mHealth program ; thus providing broad recommendations and guidance to future research ers design ing similar programs . Methods We describe the key considerations in design ing the intervention with respect to functionality , technical infrastructure , data management , software components , regulatory requirements , and operationalization . We also illustrate some of the potential issues and decision points utilizing our experience of developing text message ( short message service , SMS ) management systems to support 2 large r and omized controlled trials : TEXT messages to improve MEDication adherence & Secondary prevention ( TEXTMEDS ) and Tobacco , EXercise and dieT MEssages ( TEXT ME  ) . Results The steps identified in the development process were : ( 1 ) background research and development of the text message bank based on scientific evidence and disease-specific guidelines , ( 2 ) pilot testing with target audience and incorporating feedback , ( 3 ) software-hardware customization to enable delivery of complex personalized programs using prespecified algorithms , and ( 4 ) legal and regulatory considerations . Additional considerations in developing text message management systems include : balancing the use of customized versus preexisting software systems , the level of automation versus need for human inputs , monitoring , ensuring data security , interface flexibility , and the ability for upscaling . Conclusions A merging of expertise in clinical and behavioral sciences , health and research data management systems , software engineering , and mobile phone regulatory requirements is essential to develop a platform to deliver and manage support programs to hundreds of participants simultaneously as in TEXT ME and TEXTMEDS trials . This research provides broad principles that may assist other research ers in developing mHealth programs
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 .