scholarly journals Text4Heart II; Improving medication adherence in people with heart disease: A randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Ralph Maddison ◽  
Yannan Jiang ◽  
Ralph Stewart ◽  
Tony Scott ◽  
Andrew Kerr ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Heart Disease ◽  
New Zealand ◽  
Medication Adherence ◽  
Usual Care ◽  
Text Messaging ◽  
Controlled Trial ◽  
Health Technologies ◽  
Coronary Syndrome ◽  
Randomized Controlled

BACKGROUND Mobile health technologies offer potential to improve reach and delivery of interventions to promote long-term secondary prevention of coronary heart disease (CHD). OBJECTIVE To determine the effectiveness of a text-messaging intervention (Text4HeartII) to improve adherence to medication and lifestyle change over and above usual care in people with CHD. METHODS A two-arm, parallel, randomized controlled trial conducted in New Zealand. Participants with a recent acute coronary syndrome were randomised to receive usual cardiac services alone (control n=153) or a 24-week text message programme to support self-management plus usual cardiac services (n=153). The primary outcome was adherence with medication at 24-weeks, defined as medication possession ratio (MPR) of 80% or more for aspirin, statin and anti-hypertensive therapy. Secondary outcomes included MPR at 52-weeks, self-reported medication adherence, and adherence with healthy lifestyle behaviours at 24- and 52-weeks. RESULTS National hospitalization and pharmacy dispensing records were available for all participants; 282 (92%) completed 24-weeks questionnaire and 291 (95%) completed 52-weeks questionnaire. Adherence with 3 medication classes was greater in the control compared to the intervention group, respectively both at 24-weeks (105(69%) versus 87(57%) OR 0.60, 95%CI 0.38 to 0.96, p=0.03), and 52 weeks (104(68%) vs 83(53%) OR 0.56, 95%CI 0.35 to 0.89, p=0.01). Self-reported medication adherence score showed the same trend at 52 weeks (mean difference 0.3, 95%CI 0.01 to 0.59, p=0.04). Self-reported adherence with health related behaviours were similar between groups. CONCLUSIONS Text4HeartII did not improve dispensed medication, or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies, and highlights that the benefits of text interventions may depend on the context in which they are used. CLINICALTRIAL Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426

scholarly journals The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Jo L Byrne ◽  
Helen M Dallosso ◽  
Stephen Rogers ◽  
Laura J Gray ◽  
Ghazala Waheed ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Primary Prevention ◽  
Text Messaging ◽  
Controlled Trial ◽  
Improve Medication Adherence ◽  
Randomized Controlled ◽  
Prevention Of Cardiovascular Disease

BACKGROUND Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. OBJECTIVE This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. METHODS This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. RESULTS We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. CONCLUSIONS This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11289

scholarly journals Using a Mobile Health Intervention (DOT Selfie) With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: Protocol for a Randomized Controlled Trial

10.2196/18029 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e18029
Author(s):  
Juliet Nabbuye Sekandi ◽  
Nicole Amara Onuoha ◽  
Esther Buregyeya ◽  
Sarah Zalwango ◽  
Patrick Evans Kaggwa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Usual Care ◽  
Treatment Adherence ◽  
Mobile Health ◽  
Controlled Trial ◽  
Directly Observed Therapy ◽  
Randomized Controlled ◽  
Mdr Tb ◽  
Adherence Monitoring

Background The World Health Organization’s End TB Strategy envisions a world free of tuberculosis (TB)—free of deaths, disease, and suffering due to TB—by 2035. Nonadherence reduces cure rates, prolongs infectiousness, and contributes to the emergence of multidrug-resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex, and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard; however, it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT. Objective The study aims to evaluate the effectiveness of using video directly observed therapy (VDOT) plus incentives to improve medication adherence in TB treatment versus usual-care DOT in an African context. Methods The DOT Selfie study is an open-label, randomized controlled trial (RCT) with 2 parallel groups, in which 144 adult patients with TB aged 18-65 years will be randomly assigned to receive the usual-care DOT monitoring or VDOT as the intervention. The intervention will consist of a smartphone app, a weekly internet subscription, translated text message reminders, and incentives for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing their daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patients. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone–based “social bundle” incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow prespecified protocol measures to re-establish medication adherence. The primary endpoint is the adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups. Results This study was funded in 2019. Enrollment began in July and is expected to be completed by November 2020. Data collection and follow-up are expected to be completed by June 2021. Results from the analyses based on the primary endpoint are expected to be submitted for publication by December 2021. Conclusions This random control trial will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile health (mHealth) tools, coupled with incentives to motivate TB medication adherence. If successful, VDOT will apply to other low-income settings and a range of chronic diseases with lifelong treatment, such as HIV/AIDs. Trial Registration ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689 International Registered Report Identifier (IRRID) DERR1-10.2196/18029

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