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Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

ABSTRACT: BACKGROUND:Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. OBJECTIVE:The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). METHODS:We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. RESULTS:Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. CONCLUSIONS:Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. TRIAL REGISTRATION:ClinicalTrials.gov NCT03022669.

SUBMITTER: Park LG

PROVIDER: S-EPMC5539386 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

Park Linda G LG Collins Eileen G EG Shim Janet K JK Whooley Mary A MA

JMIR research protocols 20170718 7

<h4>Background</h4>Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence.<h4>Objective</h4>The Mobile4Meds study seeks to determine whether text messaging or a ...[more]

PMID: 28720557

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Project description:Coronary heart disease (CHD) is the leading cause of cardiovascular mortality worldwide, yet implementation of evidence-based strategies for secondary prevention remains suboptimal.This study aimed to evaluate the feasibility, specifically the usability and acceptability, and estimate the preliminary effectiveness of a mobile health (mHealth) intervention targeting both physicians and patients to improve adherence to evidence-based medications and lifestyle modifications.We conducted a 12-week pre-post interventional pilot study at two sites in Shanghai and Hainan, China. Physicians used the app designed in this study to prescribe evidence-based medicines and record patient information. Eligible and consenting patients received automatic text messages or voice calls 4 to 5 times per week for 12 weeks on medication adherence and healthy behaviors. Interviews were conducted among 10 physicians and 24 patients at the two sites for their thoughts on medication adherence and feedback on the usability and acceptability. Questions on usability and acceptability were also asked in a patient follow-up survey. With regard to estimating effectiveness, the primary outcome was medication adherence (as estimated by the Morisky Green Levine Scale) at 12 weeks. Secondary outcomes included physical activity, smoking status, fruits and vegetables consumption, and facility visit frequency.Interview findings and patient survey showed the good usability and acceptability of the intervention. Among 190 patients who completed the intervention, there was a significant increase in medication adherence (odds ratio [OR] 1.80, 95% CI 1.14-2.85). The study also showed decrease of smokers' percentage (-5%, P=.05), increase of daily vegetables consumption frequency (+0.3/day, P=.01), and community health care center visit frequency (+3 in 3 months, P=.04). The following site-specific differences were noted: medication adherence appeared to increase in Hainan (OR 14.68, 95% CI 5.20-41.45) but not in Shanghai (OR 0.61, 95% CI 0.33-1.12).Our study demonstrated that the intervention was feasible in both a tertiary care center and an urban community health center in China. Preliminary results from pre-post comparison suggest the possibility that provider and patient-linked mHealth interventions may improve medication adherence and lifestyle modifications among CHD patients, especially in resource-scarce settings. Randomized controlled trials are needed to verify the findings.

Project description:BackgroundAlthough there is an increasing use of digital adherence technologies (DATs), such as real-time monitors and SMS reminders in tuberculosis medication adherence, suboptimal patient engagement with various DATs has been reported. Additionally, financial constraints can limit DAT's utility. The perceived usefulness and the design mechanisms of DATs linked to mobile money financial incentives for tuberculosis medication management remain unclear.ObjectiveThe aim of this study is to describe the perceived usefulness and design mechanisms for a DAT intervention called My Mobile Wallet, which is composed of real-time adherence monitors, SMS reminders, and mobile money incentives to support tuberculosis medication adherence in a low-income setting.MethodsThis study used mixed methods approaches among persons with tuberculosis recruited from the Tuberculosis Clinic in the Mbarara Regional Referral Hospital. We purposively sampled 21 persons with tuberculosis aged 18 years and older, who owned cell phones and were able to use SMS text messaging interventions. We also enrolled 9 participants who used DATs in our previous study. We used focus group discussions with the 30 participants to solicit perceptions about the initial version of the My Mobile Wallet intervention, and then iteratively refined subsequent versions of the intervention following a user-centered design approach until the beta version of the intervention that suited their needs was developed. Surveys eliciting information about participants' cell phone use and perceptions of the intervention were also administered. Content analysis was used to inductively analyze qualitative data to derive categories describing the perceived usefulness of the intervention, concerns, and design mechanisms. Stata (version 13; StataCorp) was used to analyze survey data.ResultsParticipants expressed the perceived usefulness of the My Mobile Wallet intervention in terms of being reminded to take medication, supported with transport to the clinic, and money to meet other tuberculosis medication-related costs, all of which were perceived to imply care, which could create a sense of connectedness to health care workers. This could consequently cause participants to develop a self-perceived need to prove their commitment to adherence to health care workers who care for them, thereby motivating medication adherence. For fear of unintended tuberculosis status disclosure, 20 (67%) participants suggested using SMS language that is confidential-not easily related to tuberculosis. To reduce the possibilities of using the money for other competing demands, 25 (83%) participants preferred sending the money 1-2 days before the appointment to limit the time lag between receiving the money and visiting the clinic.ConclusionsDATs complemented with mobile money financial incentives could potentially provide acceptable approaches to remind, support, and motivate patients to adhere to taking their tuberculosis medication.Trial registrationClinicalTrials.gov NCT05656287; https://clinicaltrials.gov/ct2/show/NCT05656287.

Project description:BackgroundMedication nonadherence is a global public health challenge that results in suboptimal health outcomes and increases health care costs. Forgetting to take medicines is one of the most common reasons for unintentional medication nonadherence. Research findings indicate that voice-activated virtual home assistants, such as Amazon Echo and Google Home devices, may be useful in promoting medication adherence.ObjectiveThis study aims to create a medication adherence app (skill), MedBuddy, for Amazon Echo devices and measure the use, usability, and usefulness of this medication-taking reminder skill.MethodsA single-group, mixed methods, cohort feasibility study was conducted with women who took oral contraceptives (N=25). Participants were undergraduate students (age: mean 21.8 years, SD 6.2) at an urban university in the Southeast United States. Participants were given an Amazon Echo Dot with MedBuddy-a new medication reminder skill for Echo devices created by our team-attached to their study account, which they used for 60 days. Participants self-reported their baseline and poststudy medication adherence. MedBuddy use was objectively evaluated by tracking participants' interactions with MedBuddy through Amazon Alexa. The usability and usefulness of MedBuddy were evaluated through a poststudy interview in which participants responded to both quantitative and qualitative questions.ResultsParticipants' interactions with MedBuddy, as tracked through Amazon Alexa, only occurred on half of the study days (mean 50.97, SD 29.5). At study end, participants reported missing their medication less in the past 1 and 6 months compared with baseline (χ21=0.9 and χ21=0.4, respectively; McNemar test: P<.001 for both). However, there was no significant difference in participants' reported adherence to consistently taking medication within the same 2-hour time frame every day in the past 1 or 6 months at the end of the study compared with baseline (χ21=3.5 and χ21=0.4, respectively; McNemar test: P=.63 and P=.07, respectively). Overall feedback about usability was positive, and participants provided constructive feedback about the skill's features that could be improved. Participants' evaluation of MedBuddy's usefulness was overwhelmingly positive-most (15/23, 65%) said that they would continue using MedBuddy as a medication reminder if provided with the opportunity and that they would recommend it to others. MedBuddy features that participants enjoyed were an external prompt separate from their phone, the ability to hear the reminder prompt from a separate room, multiple reminders, and verbal responses to prompts.ConclusionsThe findings of this feasibility study indicate that the MedBuddy medication reminder skill may be useful in promoting medication adherence. However, the skill could benefit from further usability enhancements.

Project description:BackgroundAdherence rates of preventative medication for cardiovascular disease (CVD) have been reported as 57%, and approximately 9% of all CVD events in Europe are attributable to poor medication adherence. Mobile health technologies, particularly mobile apps, have the potential to improve medication adherence and clinical outcomes.ObjectiveThe objective of this study is to assess the effects of mobile health care apps on medication adherence and health-related outcomes in patients with CVD. This study also evaluates apps' functionality and usability and the involvement of health care professionals in their use.MethodsElectronic databases (MEDLINE [Ovid], PubMed Central, Cochrane Library, CINAHL Plus, PsycINFO [Ovid], Embase [Ovid], and Google Scholar) were searched for randomized controlled trials (RCTs) to investigate app-based interventions aimed at improving medication adherence in patients with CVD. RCTs published in English from inception to January 2020 were reviewed. The Cochrane risk of bias tool was used to assess the included studies. Meta-analysis was performed for clinical outcomes and medication adherence, with meta-regression analysis used to evaluate the impact of app intervention duration on medication adherence.ResultsThis study included 16 RCTs published within the last 6 years. In total, 12 RCTs reported medication adherence as the primary outcome, which is the most commonly self-reported adherence. The duration of the interventions ranged from 1 to 12 months, and sample sizes ranged from 24 to 412. Medication adherence rates showed statistically significant improvements in 9 RCTs when compared with the control, and meta-analysis of the 6 RCTs reporting continuous data showed a significant overall effect in favor of the app intervention (mean difference 0.90, 95% CI 0.03-1.78) with a high statistical heterogeneity (I2=93.32%). Moreover, 9 RCTs assessed clinical outcomes and reported an improvement in systolic blood pressure, diastolic blood pressure, total cholesterol, and low-density lipoprotein cholesterol levels in the intervention arm. Meta-analysis of these clinical outcomes from 6 RCTs favored app interventions, but none were significant. In the 7 trials evaluating app usability, all were found to be acceptable. There was a great variation in the app characteristics. A total of 10 RCTs involved health care professionals, mainly physicians and nurses, in the app-based interventions. The apps had mixed functionality: 2 used education, 7 delivered reminders, and 7 provided reminders in combination with educational support.ConclusionsApps tended to increase medication adherence, but interventions varied widely in design, content, and delivery. Apps have an acceptable degree of usability; yet the app characteristics conferring usability and effectiveness are ill-defined. Future large-scale studies should focus on identifying the essential active components of successful apps.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42019121385; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=121385.

Project description:BackgroundReporting of medication errors is one of the essential mechanisms to identify risky health care systems and practices that lead to medication errors. Unreported medication errors are a real issue; one of the identified causes is a burdensome medication error reporting system. An anonymous and user-friendly mobile app for reporting medication errors could be an alternative method of reporting medication error in busy health care settings.ObjectiveThe objective of this paper is to report usability testing of the Medication Error Reporting App (MERA), a mobile app for reporting medication errors anonymously.MethodsQuantitative and qualitative methods were employed involving 45 different testers (pharmacists, doctors, and nurses) from a large tertiary hospital in Malaysia. Quantitative data was retrieved using task performance and rating of MERA and qualitative data were retrieved through focus group discussions. Three sessions, with 15 testers each session, were conducted from January to March 2018.ResultsThe majority of testers were pharmacists (23/45, 51%), female (35/45, 78%), and the mean age was 36 (SD 9) years. A total of 135 complete reports were successfully submitted by the testers (three reports per tester) and 79.2% (107/135) of the reports were correct. There was significant improvement in mean System Usability Scale scores in each session of the development process (P<.001) and mean time to report medication errors using the app was not significantly different between each session (P=.70) with an overall mean time of 6.7 (SD 2.4) minutes. Testers found the app easy to use, but doctors and nurses were unfamiliar with terms used especially medication process at which error occurred and type of error. Although, testers agreed the app can be used in the future for reporting, they were apprehensive about security, validation, and abuse of feedback featured in the app.ConclusionsMERA can be used to report medication errors easily by various health care personnel and it has the capacity to provide feedback on reporting. However, education on medication error reporting should be provided to doctors and nurses in Malaysia and the security of the app needs to be established to boost reporting by this method.

Project description:INTRODUCTION:The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. METHODS AND ANALYSIS:Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. TRIAL REGISTRATION NUMBER:ACTRN12616000661471; Pre-results.

Project description:BackgroundAdherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.ObjectiveThe primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.MethodsThis study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations.ResultsPhase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.ConclusionsThis study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.Trial registrationClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128.International registered report identifier (irrid)DERR1-10.2196/15356.

Dataset Information

Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

Publications

Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

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