Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 230
- 试验地点
- 5
- 主要终点
- Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain
研究概览
简要总结
To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health coaching sessions via phone call over a 12-16 week period. This will be compared to a usual care group the receives pre-transplant care and education alone.
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
- None
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
- •Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington
排除标准
- •Under 18 years old
- •Non-English speaking, nonverbal, or extremely hard of hearing
研究组 & 干预措施
Health Coaching
Patient will work with a health coach to improve self-management skills, and receive usual pre-transplant education.
干预措施: Health Coaching (Behavioral)
Control
Patients will receive usual pre-transplant education.
结局指标
主要结局
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain
时间窗: Baseline, 12-16 Week Follow-up
Participants will complete questions comprising the CRQ Mastery subdomain (7,10,13, and 19) of a 20-item Chronic Respiratory Questionnaire (CRQ) at baseline and after the 12-week intervention. CRQ Mastery subscores measure self-management abilities and range from 1 to 7, with higher scores indicating higher self-efficacy. The minimum clinically important difference is 0.5.
Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Emotional Function Subdomain
时间窗: Baseline, 12-16 Week Follow-up
Participants will complete questions comprising the CRQ Emotional Function subdomain (6,9,12,14,16,18, and 20) of a 20-item Chronic Respiratory Questionnaire (CRQ) at baseline and after the 12-week intervention (or 12-16 weeks from baseline). CRQ Emotional Function subscores measure emotional health and range from 1 to 7, with higher scores indicating better emotional health. The minimum clinically important difference is 0.5.
次要结局
- Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews(12-16 Week Follow-up)
- Post-Transplant Quality of Life Chronic Respiratory Disease Questionnaire (CRQ) Composite(Post-Transplant Follow-up, on Average 1 Year)
研究者
Cassie C. Kennedy, M.D.
Associate Professor of Medicine
Mayo Clinic