Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial

Abstract

BackgroundCardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand.MethodsText4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention.DiscussionThe Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention.Trial registrationAustralian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426. Registered retrospectively on 1 April 2016. Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2468-z) contains supplementary material, which is available to authorized users.

Effects of mobile text messaging on breast cancer and breast self‐examination (BSE) knowledge, BSE self‐efficacy, and BSE frequency: a randomised controlled trial

“…Due to the absence of similar work, a comparison of these findings with previous research is not possible. Nevertheless, this pattern of influence did not support previous work where sending health information via text messages did not only improve the knowledge, skills, compliance, adherence and attitudes among individuals but also with their selfefficacy (19,(26)(27)(28)(29)(30)(31)(32). Again, it could be possible that factors like the SMS timing, frequency, content of the text message and even the number of text messages could have affected the outcomes of this study.…”

“…International studies have demonstrated that mobile text messaging can be an effective tool to enhance an individual's knowledge on disease, disease prevention and management, health screening methods, and healthpromoting and preventive behaviours (16,(26)(27)(29)(30)(31)(32)35). This study found that breast CA and BSE knowledge among women can be enhanced through the use of mobile text messaging.…”

“…Behavioural factors pertain to the actual BSE performance which will be measured in terms of frequency. A vast number of empirical studies utilising mobile technology had been conducted using the social cognitive theory as a theoretical underpinning (20)(21)(22)(23)(24)(25)(26)(27)(28)(29).…”

“…Although the exact mechanism on how text messaging causes behavioural change is unclear; it is believed that sending short message service (SMS) reminders prompts individuals and enhances their prospective memory, thus facilitating behavioural changes (19). Success has been seen in enhancing health-promoting behaviours such as increasing immunisations uptake, promotion of healthy behaviours such as intake of vitamin C, monitoring healthful behaviours in children and promotion of sexual health among young adults (23)(24)(25)(26)(27)(28)(29)(30)(31)(32). International studies have also shown that mobile text messaging can be an effective tool in the management of various diseases and conditions (e.g.…”

Use of Interventions to Overcome Medication Non-Adherence

“…With the advancement of technology, electronic reminder system (pager, telephone, and audio-visual devices) are being used to proactively deliver reminders. Behaviour of patients can be influenced by mobile phones due to its ease of use, worldwide acceptance and instant information transmitting capabilities (Maddison et al, 2018). These systems if united with alternate behavioural strategies could solve the problems of non-adherence largely.…”