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MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol
  1. Karla Santo1,2,
  2. Clara K Chow1,2,3,
  3. Aravinda Thiagalingam2,3,4,
  4. Kris Rogers6,
  5. John Chalmers2,7,
  6. Julie Redfern1,2
  1. 1 Cardiovascular Division, The George Institute for Global Health, Sydney, Australia
  2. 2 Sydney Medical School, University of Sydney, Sydney, Australia
  3. 3 Department of Cardiology, Westmead Hospital, Sydney, Australia
  4. 4 Cardio-respiratory Division, Westmead Institute for Medical Research, Sydney, Australia
  5. 6 Statistics Division, The George Institute for Global Health, Sydney, Australia
  6. 7 Professorial Unit, The George Institute for Global Health, Sydney, Australia
  1. Correspondence to Dr Karla Santo; ksanto{at}georgeinstitute.org.au

Abstract

Introduction The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence.

Methods and analysis Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps.

Ethics and dissemination Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums.

Trial registration number ACTRN12616000661471; Pre-results

  • Medication adherence
  • medication compliance
  • mobile phone
  • smartphone
  • apps
  • applications
  • mHealth
  • eHealth
  • coronary heart disease
  • randomised controlled trial

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/

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Footnotes

  • Contributors KS, CKC, JC and JR conceived the original concept of the study and the interventions. KS and KR performed the sample size calculations and will lead analysis of the results. KS, CKC and AT are supporting patient recruitment. KS drafted the protocol. All authors contributed to the scientific design of the study and the protocol development, are involved in the implementation of the project and have read and approved the final manuscript.

  • Funding This study is supported by a Vanguard Grant (ID101464) funded by the National Heart Foundation of Australia. KS is funded by a University of Sydney International Postgraduate Research Scholarship. CKC is funded by a Career Development Fellowship cofunded by National Health and Medical Research Council (NHMRC) and National Heart Foundation (APP1105447). JC is a chief investigator on NHMRC programme grant (ID1052555). JR is funded by a Career Development and Future Leader Fellowship cofunded by the NHMRC and the National Heart Foundation (APP1061793).

  • Competing interests None declared.

  • Ethics approval The study was approved by Western Sydney Local Health Network Human Research Ethics Committee (AU RED HREC/1/WMEAD/3).

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

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