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Cardiovascular medicine
Protocol
TEXT messages to improve MEDication adherence and Secondary prevention (TEXTMEDS) after acute coronary syndrome: a randomised clinical trial protocol
  1. Clara K Chow1,2,3,
  2. Aravinda Thiagalingam1,2,3,
  3. Karla Santo1,
  4. Cindy Kok1,3,
  5. Jay Thakkar1,2,3,
  6. Sandrine Stepien1,3,
  7. Laurent Billot1,3,
  8. Stephen Jan1,3,
  9. Rohina Joshi1,3,
  10. Graham S Hillis4,
  11. David Brieger1,5,
  12. Derek P Chew6,
  13. Karin Rådholm7,
  14. John J Atherton8,
  15. Ravinay Bhindi9,
  16. Nicholas Collins10,
  17. Steven Coverdale11,
  18. Christian Hamilton-Craig12,
  19. Nadarajah Kangaharan13,14,
  20. Andrew Maiorana15,
  21. Michelle McGrady16,
  22. Pratap Shetty17,
  23. Peter Thompson18,
  24. Anthony Rogers1,3,
  25. Julie Redfern1,2,3
  1. 1 Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia
  2. 2 Department of Cardiology, Westmead Hospital, Westmead, New South Wales, Australia
  3. 3 Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
  4. 4 Department of Cardiology, School of Medicine and Pharmacology, University of Western Australia, Royal Perth Hospital, Perth, WA, Australia
  5. 5 Department of Cardiology, Concord Repatriation General Hospital, Concord, NSW, Australia
  6. 6 Department of Cardiology, Flinders University, Adelaide, Australia
  7. 7 Division of Community Medicine, Primary Care, Department of Medicine and Health Sciences, Faculty of Health Sciences, Department of Local Care West, County Council of Östergötland, Linköping University, Linköping, Sweden
  8. 8 Department of Cardiology, Royal Brisbane and Women’s Hospital and University of Queensland School of Medicine, Brisbane, QLD, Australia
  9. 9 Department of Cardiology, Royal North Shore Hospital, St Leonards, NSW, Australia
  10. 10 Deaprtment of Cardiology, John Hunter Hospital, Newcastle, NSW, Australia
  11. 11 Department of Cardiology, Sunshine Coast University Hospital, Birtinya, QLD, Australia
  12. 12 Department of Cardiology, The Prince Charles Hospital and University of Queensland, Brisbane, QLD, Australia
  13. 13 Department of Cardiology, Royal Darwin Hospital, Darwin, NT, Australia
  14. 14 Department of Cardiology, Alice Springs Hospital, Alice Springs, NT, Australia
  15. 15 School of Physiotherapy and Exercise Science, Curtin University and Fiona Stanley Hospital, Perth, WA, Australia
  16. 16 Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia
  17. 17 Department of Cardiology, Wollongong Hospital, Wollongong, NSW, Australia
  18. 18 Department of Cardiology, Sir Charles Gairdner Hospital, Pert, WA, Australia
  1. Correspondence to Professor Clara K Chow; clara.chow{at}sydney.edu.au

Abstract

Background Identifying simple, low-cost and scalable means of supporting lifestyle change and medication adherence for patients following a cardiovascular (CV) event is important.

Objective The TEXTMEDS (TEXT messages to improve MEDication adherence and Secondary prevention) study aims to investigate whether a cardiac education and support programme sent via mobile phone text message improves medication adherence and risk factor levels in patients following an acute coronary syndrome (ACS).

Study design A single-blind, multicentre, randomised clinical trial of 1400 patients after an ACS with 12 months follow-up. The intervention group will receive multiple weekly text messages that provide information, motivation, support to adhere to medications, quit smoking (if relevant) and recommendations for healthy diet and exercise. The primary endpoint is the percentage of patients who are adherent to cardioprotective medications and the key secondary outcomes are mean systolic blood pressure (BP) and low-density lipoprotein cholesterol. Secondary outcomes will also include total cholesterol, mean diastolic BP, the percentage of participants who are adherent to each cardioprotective medication class, the percentage of participants who achieve target levels of CV risk factors, major vascular events, hospital readmissions and all-cause mortality. The study will be augmented by formal economic and process evaluations to assess acceptability, utility and cost-effectiveness.

Summary The study will provide multicentre randomised trial evidence of the effects of a text message-based programme on cardioprotective medication adherence and levels of CV risk factors.

Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health District Human Research Ethics Committee (HREC2012/12/4.1 (3648) AU RED HREC/13/WMEAD/15). Results will be disseminated via peer-reviewed publications and presentations at international conferences.

Trial registration number ACTRN12613000793718; Pre-results.

  • coronary heart disease
  • secondary prevention
  • text message
  • medication adherence
  • mhealth
  • cardiovascular risk factors

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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-019463

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    Footnotes

    • Contributors CKC had the original idea. JR, AT, DB, GSH, AR, SJ and DPC were involved in study design and protocol development. SS and LB contributed to the design of the statistical analysis approach. KS, CK, JT, RJ and KR, were involved in literature review and developing study instruments and materials. JJA, RB, NC, SC, CH-C, NK, AM, MMG, PS and PT are site PI involved in providing a critical review of the manuscript. All authors read and approved the final manuscript.

    • Funding This work is funded by a National Health and Medical Research Council (NHMRC) Project grant (ID APP1042290). CC is funded by a National Health and Medical Research Council of Australia Career Development Fellowship (APP1033478) co-funded by the Heart Foundation and a Sydney Medical School Foundation Chapman Fellowship. JR is funded by a Career Development and Future Leader Fellowship co-funded by the National Health and Medical Research Council and the National Heart Foundation (APP1061793). KS is funded by a University of Sydney International Postgraduate Scholarship. JT is funded by a University of Sydney Australian Postgraduate Award. SJ is funded by a NHMRC senior research fellowship (ID 1020430). RJ is funded by a Future Leader Fellowship funded by the National Heart Foundation (APP100484). KR is funded by a County Council of Östergötland international fellowship and the Swedish Medical Society. The organisations that supported this work (through peer-reviewed, educational research grants) had no role in study conception, data collection, analysis and interpretation, and writing of the manuscript.

    • Competing interests None declared.

    • Ethics approval Western Sydney Local Health District Human Research Ethics Committee.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.