ODYSSEE-vCHAT Pilot Trial: a Virtual Community Promoting Health Literacy, Self-Care, and Peer Support for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization
研究概览
简要总结
INTRODUCTION
Psychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes.
HYPOTHESES
At trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion.
RECRUITMENT
HF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months.
DESIGN
ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments.
ANALYSIS
Separate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p < 0.05, 2-sided.
详细描述
BACKGROUND
HF is a progressive clinical syndrome in which the heart is unable to pump oxygenated blood to meet the body's metabolic demands during exercise or at rest. At 55 years, the lifetime risk for HF is 29% for women and 33% for men. HF is a major cause of psychological distress and reduced quality of life. The 1-year rehospitalization rate is 40%. The 5-year mortality rate is 45% and 60% for women and men, respectively.
The incidence of cardiovascular mortality decreases with incremental adherence to self-care. Improvement in HF self-care also predicts greater quality of life at 12 months. However, in the absence of intervention, only 9-36% of HF patients have moderate to high adherence to these behaviours. Barriers to self-care include poor health literacy and social isolation, which are present in 39% and 25% of HF patients, respectively. These barriers are associated with depressed mood and low motivation, both of which increase the risk for poor clinical outcomes.
Home-based telehealth programs such as the present ODYSSEE-vCHAT digital initiative are changing practice standards for outpatient medical care. A telehealth program of social network support that is integrated with automated digital counselling is central to this proposal. This approach has demonstrated potential to improve overall wellbeing and sustain positive behavioural changes through information sharing, structured presentations, and role modelling.
RATIONALE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
An independent statistician logged on to a secure program (managed by the UHN THETA institute) that used randomly permuted blocks to assign subjects to ODYSSEE-vCHAT or the control group. To reduce the chance of patient allocation being predictable, we followed the convention whereby the block sizes and the fraction of each block size were known only by an independent statistician. We tested this algorithm with staff at THETA prior to subject recruitment. Our team of investigators remained blinded to ensure impartiality in decisions about procedures and analyses.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization
时间窗: Trial completion (median = 8.5 months, range = 2 to 15 months)
The primary goal of the trial is to evaluate whether use of ODYSSEE-vCHAT versus eUC reduces the risk for a composite index of incident all-cause mortality, all-cause ED visits, and HF-related hospitalization. This data will be collected using the Ontario population-based databases at the Institute for the Clinical Evaluative Sciences (ICES). Data for patients will be linked to ICES databases via Ontario Health Insurance Plan (OHIP) number, first and last name, and date of birth using deterministic/probabilistic linkage (patient unique IKN number).
次要结局
- Incidence of all-cause mortality(Trial completion (median = 8.5 months, range = 2 to 15 months))
- Incidence of all-cause ED visits(Trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported health-related quality of life(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported depression(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported anxiety(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Incidence of HF-related hospitalization(Trial completion (median = 8.5 months, range = 2 to 15 months))
- Engagement with HF self-care resources(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Adherence to heart failure self-care behaviours(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported engagement in activities for living well(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported overall mental health(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported loneliness(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported perceived social support(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported alcohol, nicotine, and cannabis use(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported psychological wellbeing(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported involvement in medical care(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported health literacy(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))
- Self-reported physical wellbeing(Months 4, 8, and 12 and trial completion (median = 8.5 months, range = 2 to 15 months))