ODYSSEE-vCHAT Mental Health Study: A Virtual Community Promoting Health Literacy, Self-Care, and Peer Support for Heart Failure and Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 215
- 试验地点
- 4
- 主要终点
- Self-reported overall mental health
研究概览
简要总结
INTRODUCTION
Psychological distress and reduced quality of life are prevalent in patients with chronic heart failure (CHF) and advanced chronic kidney disease (CKD). In addition, persons with CHF or CKD live with increased risk of primary or secondary complications associated with COVID-19, including mortality. International task force committees report that medical therapy combined with counselling for CHF and CKD self-care optimizes clinical outcomes. Digital health initiatives present an effective solution in light of the recent issue of declining patient attendance in essential outpatient appointments due to the increased risk of COVID-19 exposure.
HYPOTHESES
At study completion (up to 16 months), it is hypothesized that there will be a significant increase from baseline in the proportion of participants with clinically improved or sustained positive mental health. Additionally, greater engagement with the ODYSSEE-vCHAT program is expected to be linked with improved self-reported health- and wellbeing-related outcomes at months 4 and 8 and study completion (up to 16 months).
RECRUITMENT
Patients with CHF or CKD who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, The Ottawa Hospital, and the community. Accrual of the sample (N = 215) occurred over a 14-month period.
DESIGN
This is a single group, open label, pre-post study with assessments at baseline, months 4 and 8, and study completion (up to 16 months). ODYSSEE-vCHAT contacted subjects each week inviting them to participate or partake in digital counselling resources, chatrooms, and presentations with group discussions. Participation in supplemental mental health programs was monitored by self-report.
ANALYSES
A binomial logistic regression will evaluate if there is a greater proportion of participants with positive mental health at study completion. This analysis will assess if the proportion of participants with positive mental health at study completion (up to 16 months) is independently associated with ODYSSEE-vCHAT engagement (login minutes). General linear models will test secondary outcomes, adjusting for baseline assessments and potential covariates. Significance in all tests will be p < 0.05, 2-sided. Any unplanned analyses will be adjusted for using the Bonferroni procedure.
详细描述
BACKGROUND
Mental health needs are pronounced for individuals with CHF or advanced CKD. Clinically significant symptoms of depression and anxiety are prevalent in 22% and 33% of outpatients with CHF, respectively, and 26% and 12-52% of outpatients with CKD, respectively. Two psychosocial factors are known to compound the disease burden experienced by persons with these chronic progressive conditions: Diminished social support and isolation. These factors compromise patients' psychological wellbeing and quality of life, while contributing to caregiver burden or stress. Additionally, persons with CHF or CKD experience an increased risk of exposure to COVID-19 and associated mortality. The impact of the pandemic on mental health includes greater symptoms of anxiety, mood disturbance, social isolation due to social distancing, disruption to sleep or eating patterns, impaired concentration due to stress, and use of drugs or alcohol.
A digital program of social network support that is integrated with automated counselling is central to this proposal. This approach has demonstrated a potential to improve psychological wellbeing and quality of life while reducing social isolation, increase patient engagement with digital programs, and sustain preventive self-care for mental health with positive role modelling, information sharing, and structured presentations. Home-based digital health programs are changing practice standards for outpatient medical care. This development is consistent with task force guidelines for infection prevention and control that advocate for the development of virtual outpatient programs. Digital health initiatives are also well-suited to effectively address the recent problem that patients are declining to attend essential outpatient appointments due to fear of COVID-19 exposure.
The present study will generate novel insights on how to optimize the efficacy and usability of a scalable, evidence-based digital program where social network technology and automated counselling are used synergistically to promote mental health for persons at increased risk for COVID-19.
RATIONALE
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
Self-reported overall mental health
时间窗: Baseline and study completion (up to 16 months)
The primary goal of the study is to evaluate whether engagement with ODYSSEE-vCHAT significantly changes from baseline the proportion of participants with clinically improved or sustained positive mental health (defined as a "minimally important increase" of at least 3.8 points or a score of at least 65 on the MCS) at study completion.
次要结局
- Self-reported engagement in goal-directed activities for living well(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported depression(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported loneliness(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported psychological wellbeing(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported CKD health-related quality of life(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported adherence to self-care behaviours (CHF only)(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported social support(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported anxiety(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported CHF health-related quality of life(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported active involvement in medical care(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported alcohol, nicotine, and cannabis use(Baseline, months 4 and 8, and study completion (up to 16 months))
- Engagement with self-care resources(Baseline, months 4 and 8, and study completion (up to 16 months))
- Self-reported physical functioning(Baseline, months 4 and 8, and study completion (up to 16 months))
研究者
Robert Nolan
Senior Scientist
University Health Network, Toronto