Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial.

Rachel Grace Peiris, Heather Ross, Christopher T Chan, Stephanie Poon, Bourne Lewis Auguste, Valeria E Rac, Michael Farkouh, Michael McDonald, Janusz Kaczorowski, Jillianne Code, Juan Duero Posada, Stephanie Ong, Jeremy Kobulnik, George Tomlinson, Ella Huszti, JoAnne Arcand, Scott G Thomas, Ayub Akbari, Robert Maunder, Steven Grover, Emily Seto, Anne Simard, Brad Pope, Marc Bains, Carmen McIntyre, Chris Torbay, Fatima Syed, Robert P Nolan

Journal: BMJ open 2023;12(9):e059635

PMID: 36691152

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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.

Address: Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.; Institute of Medical Science, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.; Division of Cardiology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.; Division of Nephrology, University Health Network, Toronto, Ontario, Canada.; Division of Nephrology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.; Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.; Division of Nephrology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.; Division of Nephrology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.; Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.; Program for Health System and Technology Evaluation, Ted Rogers Centre for Heart Research, University Health Network, Toronto, Ontario, Canada.; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.; Peter Munk Centre of Excellence in Multinational Clinical Trials, University Health Network, Toronto, Ontario, Canada.; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.; Department of Family and Emergency Medicine, University of Montreal Faculty of Medicine, Montreal, Quebec, Canada.; Department of Curriculum and Pedagogy, University of British Columbia, Vancouver, British Columbia, Canada.; HeartLife Foundation, Vancouver, British Columbia, Canada.; Division of Nephrology, University Health Network, Toronto, Ontario, Canada.; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.; Division of Cardiology, Sinai Health System, Toronto, Ontario, Canada.; Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada.; Division of Biostatistics, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.; Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.; Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada.; Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, Ontario, Canada.; Department of Nutritional Sciences, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.; Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada.; Division of Nephrology, Ottawa Hospital, Ottawa, Ontario, Canada.; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.; Department of Psychiatry, Sinai Health System, Toronto, Ontario, Canada.; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.; Department of Medicine, McGill University, Montreal, Quebec, Canada.; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.; Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.; Centre for Global eHealth Innovation, University Health Network, Toronto, Ontario, Canada.; Program for Health System and Technology Evaluation, Ted Rogers Centre for Heart Research, University Health Network, Toronto, Ontario, Canada.; Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.; HeartLife Foundation, Vancouver, British Columbia, Canada.; Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada [email protected].; Institute of Medical Science, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.

DOI: 10.1136/bmjopen-2021-059635

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MeSH Terms: Humans, Quality of Life, Counseling, Heart Failure, Heart Diseases, Social Networking, Randomized Controlled Trials as Topic