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.
BMJ Open. 2022 Sep 5;12(9):e059635. doi: 10.1136/bmjopen-2021-059635.
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.
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.
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.
NCT04966104.
心力衰竭（HF）症状通过自我护理得到改善，尽管临床团队为这些行为提供了教育，但患者的依从性仍然很低。开放获取数字社区促进自我护理、同伴支持和健康素养（ODYSSEE-vCHAT）将自动数字咨询与社交网络支持相结合，以改善死亡率和发病率、自我护理材料的参与度以及与健康相关的生活质量。
通过互联网连接的个人计算机，将 162 名 HF 患者使用 ODYSSEE-vCHAT 与对照条件进行比较，为期 22 个月。主要结果是试验结束时全因死亡率、全因急诊就诊和 HF 相关住院的综合指数评分。次要结果包括复合指数的各个组成部分、自我护理材料的参与度以及患者报告的身体和心理社会健康、疾病管理、健康素养和物质使用的测量。患者从加拿大多伦多的三级保健医院招募，并按 1:1 的比例随机分配到试验的两个臂。在线评估在基线（t=0）、第 4、8 和 12 个月以及试验结束时进行。有序逻辑回归分析和广义线性模型将评估主要和次要结果。
该试验已获得大学健康网络研究伦理委员会（20-5960）、桑尼布鲁克医院（5117）和西奈山医院（21-022-E）的批准。符合条件的患者以当面或在线的方式获得知情同意。研究结果将与主要利益相关者和公众共享。结果将为在加拿大范围内开展 III 期试验以评估 ODYSSEE-vCHAT 改善临床结局和提高门诊护理标准的疗效做好准备。
NCT04966104。
