Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Global Psychological Distress
研究概览
简要总结
This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and improve functional capacity. Half of the patients will receive CSTEX and half will receive the standard of care plus transplant education (SOC-ED).
详细描述
The study will aim to evaluate the effectiveness of the CSTEX intervention in (i) reducing distress and (ii) improving functional capacity. It is hypothesized that compared to SOC-ED, the CSTEX intervention will result in 1) greater reductions in global distress measured by an established psychometric test battery; and 2) greater improvements in functional capacity assessed by distance walked on a standard Six Minute Walk test (6MWT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Single or bilateral first lung transplant recipient; discharged from the hospital and at least 6 weeks post-transplant; completed post-transplant pulmonary rehabilitation within the past 18 months; on stable medication regimen; proficient in the English language
排除标准
- •Illness such as malignancies that are associated with a life-expectancy of < 12 months; current pregnancy; inability to read or to provide informed consent; multi-organ transplant recipient or repeat lung transplant.
结局指标
主要结局
Change in Global Psychological Distress
时间窗: Baseline to 12 weeks
A composite distress score will assess change from baseline to 12 weeks (post-intervention) and combine the following instruments: General Health Questionnaire, Perceived Stress Scale, Beck Depression Inventory-II, State Trait Anxiety Inventory, and PROMIS Anger. The composite distress score is the average of the participant's rank for change (from baseline to 12 weeks) on each of the 5 scales. A lower rank represents more improvement (decrease in global distress) and higher ranks represent less improvement (or worsening of distress). Scoring is based on the number of participants analyzed; in this case the possible score range is 1-180. The change value is calculated as T2 (12 weeks) - T1 (baseline).
次要结局
- Change in Functional Capacity(Baseline to 12 weeks)
- Change in Physical Activity(Baseline to 12 weeks)
- Change in Sleep Quality(Baseline to 12 weeks)
- Change in Quality of Life(Baseline to 12 weeks)
- Change in Frailty(Baseline to 12 weeks)
- Change in Problem-Focused Coping(Baseline to 12 weeks)
- Change in Self-Efficacy(Baseline to 12 weeks)
- Chronic Lung Allograft Dysfunction (CLAD) Free Survival(Up to 3 years post-treatment)
- Change in Emotion-Focused Coping(Baseline to 12 weeks)
- Change in Avoidant Coping(Baseline to 12 weeks)