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

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Diabetes and endocrinology
Protocol
Text messaging support for patients with diabetes or coronary artery disease (SupportMe): protocol for a pragmatic randomised controlled trial
  1. Ngai Wah Cheung1,2,3,
  2. Julie Redfern2,3,
  3. Aravinda Thiagalingam3,4,
  4. Tien-Ming Hng5,
  5. Sheikh Mohammed Shariful Islam6,
  6. Rabbia Haider1,
  7. Sonia Faruquie1,
  8. Clara Chow2,3,4
  9. On behalf of the SupportMe investigators
    1. 1 Diabetes & Endocrinology, University of Sydney, Westmead, New South Wales, Australia
    2. 2 Westmead Applied Research Centre, University of Sydney, Westmead, New South Wales, Australia
    3. 3 Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia
    4. 4 Cardiology Department, Westmead Hospital, Westmead, New South Wales, Australia
    5. 5 Diabetes & Endocrinology, Blacktown Mount Druitt Hospital, Blacktown, New South Wales, Australia
    6. 6 The George Institute for Global Health, Sydney, New South Wales, Australia
    1. Correspondence to Professor Ngai Wah Cheung; wah.cheung{at}sydney.edu.au

    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.

    • general diabetes
    • coronary heart disease
    • clinical trials
    • telemedicine

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

    https://doi.org/10.1136/bmjopen-2018-025923

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      Footnotes

      • Contributors CC, NWC, SMSI, JR and AT conceived the original study concept. All authors contributed to the design of the study, protocol development, its implementation and drafting of the manuscript.

      • Funding This study is funded by the Translational Research Grants Scheme of NSW Health. JR is funded by a National Health and Medical Research Council (NHMRC) Career Development Fellowship (APP1143538). CC is funded by a Career Development Fellowship cofunded by the NHMRC and National Heart Foundation (APP1105447). SMSI is funded by The George Institute for Global Health Post Doctorate Research Fellowship and has received funding from High Blood Pressure Research Foundation of Australia. RH is funded by a Westmead Hospital Jerry Koutts Scholarship.

      • Competing interests None declared.

      • Ethics approval The study has been approved by the Western Sydney Local Health District Human Research Ethics Committee.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Collaborators The SupportMe Investigators: David Burgess, Bridie Carr, N Wah Cheung, Jin Gun Cho, Clara K Chow, Michael Crampton, Sonia Faruquie, Cate Ferry, Rabbia Haider, Alison Hayes, Tien-Ming Hng, Sheikh Mohammed Shariful Islam, Stephen Leeder, Simon Raadsma, Julie Redfern, Chris Rissel and Aravinda Thiagalingam.

      • Patient consent for publication Not required.