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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Ralph Maddison, Ralph Stewart, Rob Doughty, Tony Scott, Andrew Kerr, Jocelyne Benatar, Robyn Whittaker, Jonathan C. Rawstorn, Anna Rolleston, Yannan Jiang, Paul Estabrooks, Rachel Karen Sullivan, Hannah Bartley, Leila Pfaeffli Dale
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2468-z) contains supplementary material, which is available to authorized users.

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: ACTRN12616000422​426. Registered retrospectively on 1 April 2016. 
Zusatzmaterial
Additional file 1: SPIRIT Checklist. (DOC 120 kb)
13063_2018_2468_MOESM1_ESM.doc
Literatur
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