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Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial.
Peiris, Rachel Grace; Ross, Heather; Chan, Christopher T; Poon, Stephanie; Auguste, Bourne Lewis; Rac, Valeria E; Farkouh, Michael; McDonald, Michael; Kaczorowski, Janusz; Code, Jillianne; Duero Posada, Juan; Ong, Stephanie; Kobulnik, Jeremy; Tomlinson, George; Huszti, Ella; Arcand, JoAnne; Thomas, Scott G; Akbari, Ayub; Maunder, Robert; Grover, Steven; Seto, Emily; Simard, Anne; Pope, Brad; Bains, Marc; McIntyre, Carmen; Torbay, Chris; Syed, Fatima; Nolan, Robert P.
  • Peiris RG; Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
  • Ross H; Institute of Medical Science, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.
  • Chan CT; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.
  • Poon S; Division of Cardiology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.
  • Auguste BL; Division of Nephrology, University Health Network, Toronto, Ontario, Canada.
  • Rac VE; Division of Nephrology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.
  • Farkouh M; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.
  • McDonald M; Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
  • Kaczorowski J; Division of Nephrology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.
  • Code J; Division of Nephrology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
  • Duero Posada J; Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.
  • Ong S; Program for Health System and Technology Evaluation, Ted Rogers Centre for Heart Research, University Health Network, Toronto, Ontario, Canada.
  • Kobulnik J; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.
  • Tomlinson G; Peter Munk Centre of Excellence in Multinational Clinical Trials, University Health Network, Toronto, Ontario, Canada.
  • Huszti E; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.
  • Arcand J; Department of Family and Emergency Medicine, University of Montreal Faculty of Medicine, Montreal, Quebec, Canada.
  • Thomas SG; Department of Curriculum and Pedagogy, University of British Columbia, Vancouver, British Columbia, Canada.
  • Akbari A; HeartLife Foundation, Vancouver, British Columbia, Canada.
  • Maunder R; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.
  • Grover S; Division of Nephrology, University Health Network, Toronto, Ontario, Canada.
  • Seto E; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
  • Simard A; Division of Cardiology, University Health Network, Toronto, Ontario, Canada.
  • Pope B; Division of Cardiology, Sinai Health System, Toronto, Ontario, Canada.
  • Bains M; Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada.
  • McIntyre C; Division of Biostatistics, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.
  • Torbay C; Institute of Health Policy, Management, and Evaluation, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.
  • Syed F; Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada.
  • Nolan RP; Faculty of Health Sciences, University of Ontario Institute of Technology, Oshawa, Ontario, Canada.
BMJ Open ; 12(9): e059635, 2022 Sep 05.
Article in English | MEDLINE | ID: covidwho-2020040
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 11 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Heart Diseases / Heart Failure Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2022 Document Type: Article Affiliation country: Bmjopen-2021-059635

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Heart Diseases / Heart Failure Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMJ Open Year: 2022 Document Type: Article Affiliation country: Bmjopen-2021-059635