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

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

The EvalUation of goal-diRected activities to prOmote well-beIng and heAlth (EUROIA) scale: Psychometric evaluation with Confirmatory Factor Analysis

“…The recruitment period for this study began October 25 th , 2021 and ended on January 16 th , 2023. Baseline assessment data were obtained from (i) a single group, open label, pre-post study [ 37 ] and (ii) a double-arm, parallel group, randomized controlled trial [ 38 ]. The sample estimate for the ODYSSEE-vCHAT study accounted for changes in the Mental Component Score from the 36-Item Short Form questionnaire over a period of 3 to 12 months, while the sample estimate for the ODYSSEE-vCHAT trial was based on change over 12 months in a composite index of all-cause mortality and hospitalization.…”

“…No financial incentives were offered. Participants were referred from participating clinics at the University Health Network (UHN; primary site), Mount Sinai Hospital, and Sunnybrook Hospital in Toronto, Canada [ 37 , 38 ]. Assessment data for the present investigation were obtained from baseline assessments.…”

“…The ODYSSEE-vCHAT study [ 37 ] and trial [ 38 ] were conducted according to principles of the Declaration of Helsinki [ 40 ]. All procedures were reviewed and approved by the ethics board of each participating site (UHN: 20–5960 and 20–6005; Sunnybrook: 5117 and 3787; Mount Sinai: 21-022-E and 21-0057-E).…”