Text messaging support for patients with diabetes or coronary artery disease (SupportMe): protocol for a pragmatic randomised controlled trial

Abstract

Introduction: Low-cost interventions providing self-management support are needed for people with coronary artery disease (CAD) and diabetes. Mobile phone text messaging provides a potential vehicle for this. The SupportMe Trial aims to assess the feasibility of embedding a text messaging programme into routine clinical practice and will determine if this improves cardiovascular risk factor and diabetes control among patients with CAD or type 2 diabetes.

Methods and analysis: SupportMe is a randomised controlled trial to be conducted within the framework of a health district-wide integrated care programme for people with CAD or type 2 diabetes mellitus. One thousand subjects will be recruited, with at least 500 in each group. Intervention subjects will receive four text messages a week for 6 months, which provide advice, motivation, information and support for disease management and healthy behaviour. The primary outcome is systolic blood pressure at 6 months. Secondary outcomes include body mass index, waist circumference, low-density lipoprotein cholesterol, physical activity levels, dietary intake, quality of life, mood and smoking cessation, and for subjects with diabetes, glycosylated haemoglobin and fasting serum glucose. A process and economic evaluation will also be conducted.

Ethics and dissemination: The study has been approved by the Western Sydney Local Health District Human Research Ethics Committee (AU RED HREC/16/WMEAD/331). Results will be disseminated via the scientific forums including peer-reviewed publications and presentations at national and international conferences.

Trial registration number: ACTRN12616001689460.

Keywords: clinical trials; coronary heart disease; general diabetes; telemedicine.

Figure 1

Study flow diagram. CAD, coronary artery disease; CV, cardiovascular.