Maddison Ralph, Stewart Ralph, Doughty Rob, Scott Tony, Kerr Andrew, Benatar Jocelyne, Whittaker Robyn, Rawstorn Jonathan C, Rolleston Anna, Jiang Yannan, Estabrooks Paul, Sullivan Rachel Karen, Bartley Hannah, Pfaeffli Dale Leila
Institute for Physical Activity and Nutrition, Deakin University, Geelong, VIC, Australia.
Department of Cardiology, Auckland District Health Board, Auckland, New Zealand.
Trials. 2018 Jan 25;19(1):70. doi: 10.1186/s13063-018-2468-z.
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.
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.
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.
Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426 . Registered retrospectively on 1 April 2016.
心脏康复（CR）是当代冠心病患者管理的重要组成部分，包括急性冠状动脉综合征（ACS）后的康复。CR通常包括教育和支持，以帮助ACS患者改变生活方式并预防后续事件。尽管有诸多益处，但传统CR项目的参与率较低。移动技术（移动健康）的应用为改善CR支持的覆盖范围、可及性和提供方式提供了潜力。我们旨在确定短信干预（Text4Heart II）在ACS患者常规护理基础上，改善药物依从性和生活方式改变的有效性和成本效益。第二个目标是使用RE-AIM框架，为Text4Heart II在新西兰医疗服务体系中的潜在实施提供信息。
Text4Heart II是一项双臂、平行对照、优效性随机对照试验，在新西兰奥克兰的两家大型都市医院进行。330名参与者将被随机分为两组，一组接受为期24周基于理论和证据的个性化短信项目，以支持自我管理，同时接受常规CR；另一组仅接受常规CR（对照组）。在6个月和12个月时评估结果。主要结局是通过配药记录测量的6个月时参与者的药物依从率。次要结局包括12个月时的药物依从性、使用综合健康行为评分测量的参与者坚持自我报告的健康行为（体育活动、水果和蔬菜摄入、适度饮酒和吸烟状况）的比例、自我报告的药物依从性、心血管危险因素（血脂、血压）、6个月和12个月时的再入院情况及相关住院事件。还将进行成本效益分析。使用RE-AIM框架，我们将确定干预措施的采用情况和可持续性。
Text4Heart II试验将确定短信干预在6个月和12个月时改善药物依从性和生活方式行为的有效性。通过使用RE-AIM框架，该试验将提供急需的数据，并深入了解Text4Heart II的潜在实施情况。该试验解决了先前移动健康试验的许多局限性/批评；它基于我们的Text4Heart试点试验，样本量充足，有足够的时间引发行为改变，且随访评估（6个月和12个月）足够长，以确定干预措施的持续效果。
澳大利亚新西兰临床试验注册中心，编号：ACTRN12616000422426。于2016年4月1日追溯注册。
