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Cardiovascular medicine
Protocol
Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial
  1. Rachel Grace Peiris1,2,
  2. Heather Ross3,4,
  3. Christopher T Chan5,6,
  4. Stephanie Poon3,7,
  5. Bourne Lewis Auguste6,8,
  6. Valeria E Rac9,10,
  7. Michael Farkouh3,11,
  8. Michael McDonald3,
  9. Janusz Kaczorowski12,
  10. Jillianne Code13,14,
  11. Juan Duero Posada3,
  12. Stephanie Ong5,15,
  13. Jeremy Kobulnik3,16,
  14. George Tomlinson17,18,
  15. Ella Huszti9,17,
  16. JoAnne Arcand19,20,
  17. Scott G Thomas21,
  18. Ayub Akbari22,23,
  19. Robert Maunder24,25,
  20. Steven Grover26,27,
  21. Emily Seto9,28,
  22. Anne Simard10,
  23. Brad Pope1,
  24. Marc Bains14,
  25. Carmen McIntyre1,
  26. Chris Torbay1,
  27. Fatima Syed1,2,
  28. Robert P Nolan1,2,25
  1. 1Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
  2. 2Institute of Medical Science, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
  3. 3Division of Cardiology, University Health Network, Toronto, Ontario, Canada
  4. 4Division of Cardiology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
  5. 5Division of Nephrology, University Health Network, Toronto, Ontario, Canada
  6. 6Division of Nephrology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
  7. 7Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  8. 8Division of Nephrology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  9. 9Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada
  10. 10Program for Health System and Technology Evaluation, Ted Rogers Centre for Heart Research, University Health Network, Toronto, Ontario, Canada
  11. 11Peter Munk Centre of Excellence in Multinational Clinical Trials, University Health Network, Toronto, Ontario, Canada
  12. 12Department of Family and Emergency Medicine, University of Montreal Faculty of Medicine, Montreal, Quebec, Canada
  13. 13Department of Curriculum and Pedagogy, University of British Columbia, Vancouver, British Columbia, Canada
  14. 14HeartLife Foundation, Vancouver, British Columbia, Canada
  15. 15Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada
  16. 16Division of Cardiology, Sinai Health System, Toronto, Ontario, Canada
  17. 17Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada
  18. 18Division of Biostatistics, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada
  19. 19Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, Ontario, Canada
  20. 20Department of Nutritional Sciences, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
  21. 21Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada
  22. 22Division of Nephrology, Ottawa Hospital, Ottawa, Ontario, Canada
  23. 23Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  24. 24Department of Psychiatry, Sinai Health System, Toronto, Ontario, Canada
  25. 25Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
  26. 26Department of Medicine, McGill University, Montreal, Quebec, Canada
  27. 27Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada
  28. 28Centre for Global eHealth Innovation, University Health Network, Toronto, Ontario, Canada
  1. Correspondence to Dr Robert P Nolan; Rob.Nolan{at}uhnresearch.ca

Abstract

Introduction Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE–vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self–care materials, and health-related quality of life.

Methods and analysis Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes.

Ethics and dissemination The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care.

Trial registration number NCT04966104

  • Heart failure
  • Quality in health care
  • Telemedicine
  • World Wide Web technology
  • Clinical trials
http://creativecommons.org/licenses/by-nc/4.0/

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-2021-059635

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    Footnotes

    • Contributors All authors have contributed to the writing of this paper and the review of its contents.

    • Funding This work is supported by the Canadian Institutes of Health Research (CIHR; PJT173222). The CIHR is not involved in the study design, the collection, management, analysis, or interpretation of data, the writing of reports, or the decision to submit reports for publication. Tel: (613) 954-1968. E-mail: support-soutien@cihr-irsc.gc.ca.

    • Competing interests None declared.

    • Patient and public involvement Patients representatives are involved in the conduct and oversight of this research. Refer to the Methods and Discussion sections for further details.

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

    • Citation Peiris R G, Ross H, Chan C T, et al. Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial. BMJ Open 2022;0:e059635. doi:10.1136/bmjopen-2021-059635

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.