Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial
Scott G Thomas,
Heather Ross,
Bourne Lewis Auguste,
Christopher T Chan,
Ayub Akbari,
Robert P Nolan,
Emily Seto,
Juan Duero Posada,
Michael McDonald,
Robert Maunder,
George Tomlinson,
Valeria E Rac,
Michael Farkouh,
Ella Huszti,
Janusz Kaczorowski,
Stephanie Ong,
Rachel Grace Peiris,
Stephanie Poon,
Jillianne Code,
Jeremy Kobulnik,
JoAnne Arcand,
Steven Grover,
Anne Simard,
Brad Pope,
Marc Bains,
Carmen McIntyre,
Chris Torbay,
Fatima Syed
Affiliations
Scott G Thomas
Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada
Heather Ross
Division of Cardiology, University Health Network, Toronto, Ontario, Canada
Bourne Lewis Auguste
Division of Nephrology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada
Christopher T Chan
Division of Nephrology, University Health Network, Toronto, Ontario, Canada
Ayub Akbari
Division of Nephrology, Ottawa Hospital, Ottawa, Ontario, Canada
Robert P Nolan
Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
Emily Seto
Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada
Juan Duero Posada
Division of Cardiology, University Health Network, Toronto, Ontario, Canada
Michael McDonald
Division of Cardiology, University Health Network, Toronto, Ontario, Canada
Robert Maunder
Department of Psychiatry, Sinai Health System, Toronto, Ontario, Canada
George Tomlinson
Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada
Valeria E Rac
Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada
Michael Farkouh
Division of Cardiology, University Health Network, Toronto, Ontario, Canada
Ella Huszti
Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada
Janusz Kaczorowski
Department of Family and Emergency Medicine, University of Montreal Faculty of Medicine, Montreal, Quebec, Canada
Stephanie Ong
Division of Nephrology, University Health Network, Toronto, Ontario, Canada
Rachel Grace Peiris
Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
Stephanie Poon
Division of Cardiology, University Health Network, Toronto, Ontario, Canada
Jillianne Code
Department of Curriculum and Pedagogy, University of British Columbia, Vancouver, British Columbia, Canada
Jeremy Kobulnik
Division of Cardiology, University Health Network, Toronto, Ontario, Canada
JoAnne Arcand
Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, Ontario, Canada
Steven Grover
Department of Medicine, McGill University, Montreal, Quebec, Canada
Anne Simard
Program for Health System and Technology Evaluation, Ted Rogers Centre for Heart Research, University Health Network, Toronto, Ontario, Canada
Brad Pope
Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
Marc Bains
HeartLife Foundation, Vancouver, British Columbia, Canada
Carmen McIntyre
Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
Chris Torbay
Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
Fatima Syed
Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada
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
