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. 2018 Jan 25;19(1):70.
doi: 10.1186/s13063-018-2468-z.

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

Ralph Maddison  1 , Ralph Stewart  2 , Rob Doughty  3 , Tony Scott  4 , Andrew Kerr  5 , Jocelyne Benatar  2 , Robyn Whittaker  6 , Jonathan C Rawstorn  7 , Anna Rolleston  8 , Yannan Jiang  6 , Paul Estabrooks  9 , Rachel Karen Sullivan  10 , Hannah Bartley  6 , Leila Pfaeffli Dale  11
Affiliations

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

Ralph Maddison et al. Trials. .

Abstract

Background: Cardiac 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.

Methods: Text4Heart 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.

Discussion: The 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 registration: Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426 . Registered retrospectively on 1 April 2016.

Keywords: Cardiovascular disease; Risk factors; Self-management; Text messaging.

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Conflict of interest statement

Ethics approval and consent to participate

Text4Heart II received ethical approval from the New Zealand Health and Disability Ethics Committee, Northern A (15/NTA/205); internal approval was also granted by the Auckland and Waitemata District Health Board Research Review Committees. All participants will provide written or verbal consent as described above.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrollment, interventions, and assessments (Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure)
See this image and copyright information in PMC

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