The CF Wellness Program to Treat Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Proportion of cognitive behavioral therapy (CBT) sessions completed
研究概览
简要总结
This research is being done to learn more ways to treat non-respiratory symptoms in people with CF including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.
详细描述
This study aims to test the acceptability, feasibility and preliminary efficacy of a tailored intervention known as the CF Wellness Program (CFWP) to treat clinically elevated fatigue in adults with CF. This is a pre-post pilot intervention study of the CF-Wellness Program. This study is needed because fatigue negatively affects health-related quality of life and has been identified by those with CF as a symptom that needs to be addressed. The study will include approximately 50 participants and the intervention will last approximately 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •≥18 years old
- •Documentation of CF diagnosis in the medical record
- •If prescribed a modulator (i.e., ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, & elexacaftor/tezacaftor/ivacaftor), have been on treatment for at least 4 weeks
- •If prescribed medicine for psychiatric purpose, must be on treatment for at least 8 weeks
- •Has access to a smartphone, tablet, and/or computer with access to internet
- •Ability to understand/read/speak English
- •Receives CF care at a participating CF Center
- •Has a score of >4 on the Fatigue Severity Scale
- •Not likely to start and/or change modulator treatments during the intervention period
排除标准
- •Receiving antibiotic treatment for a pulmonary exacerbation 14 days prior to the screening or expected to start within 14 days after screening visit
- •Is pregnant or less than 6 months postpartum (self-reported)
- •Is currently participating in another interventional trial
- •Contraindication for aerobic exercise (determined by treating physician including cardiovascular, pulmonary and/or musculoskeletal contraindications)
- •Forced Expiratory Volume in 1 second percent predicted (FEV1pp) is <25% within last year
- •Planning to transfer care to a non-participating CF Center before the post-intervention visit could be completed
- •Will not be available to complete CF-Wellness sessions in a timely fashion (e.g., will be on extended travel)
- •Has already participated in the CF Wellness Program
结局指标
主要结局
Proportion of cognitive behavioral therapy (CBT) sessions completed
时间窗: At approximately 13 weeks post intervention
Mean of the number of completed cognitive behavioral therapy (CBT) sessions divided by the number of sessions expected per participant.
Proportion enrolled in the CF Wellness Program (CFWP)
时间窗: Day 0
Number of participants enrolled into the CFWP Intervention among those eligible.
Proportion of weeks participant synced the fitness tracker watch to the Smartphone app
时间窗: At approximately 13 weeks post intervention
This will be measured as the mean of the number of syncs completed divided by the number expected per participant. The fitness tracker watch with smartphone app data will be used to assess the proportion of weeks participant synced the fitness tracker watch to the Smartphone app.
次要结局
- Mean change in fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue ( FACIT-F) Scale(Day 1 to approximately 13 weeks post intervention)
- Change in exercise capacity as assessed by the 1 Minute Sit to Stand Test (1MSTST) test and Fitness tracker watch(Day 1 to approximately 13 weeks post intervention)
- Acceptability of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients(At approximately 13 weeks post intervention)
- Qualitative interview as assessed by thematic analysis(At approximately 13 weeks post intervention)
- Change self-reported sleep disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)(Day 1 to approximately 13 weeks post intervention)
- Change in self-reported anxiety as assessed by the General Anxiety Disorder - 7 (GAD7) scale(Day 1 to approximately 13 weeks post intervention)
- Feasibility of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients(At approximately 13 weeks post intervention)
- Change in self-reported depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)(Day 1 to approximately 13 weeks post intervention)
- Change in self-reported pain as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity scale(Day 1 to approximately 13 weeks post intervention)