Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 460
- 试验地点
- 4
- 主要终点
- King's Brief Interstitial Lung Disease (K- BILD)
研究概览
简要总结
The purpose of this clinical trial is to determine the impact of a home-based pulmonary rehabilitation program with health coaching on patient-reported respiratory-related quality of life and physical activity, as compared to usual care in patients with fibrotic interstitial lung disease.
详细描述
The fibrotic interstitial lung diseases (f-ILD) are a group of progressive and debilitating lung diseases sharing characteristics of lung scarring on imaging and restricted breathing on pulmonary function testing (PFT). Symptoms include shortness of breath, cough, and fatigue, eventually leading to deconditioning and poor quality of life. While medical therapies are available for slowing or stopping the loss of lung function, only pulmonary rehabilitation (PR) has shown a positive impact on patient-reported shortness of breath and physical activity. Unfortunately, PR may not be widely available to all patients, and some patients may become too ill to participate in traditional center-based programs.
A primary hypothesis is that modifying the content, delivery, and setting for PR in patients with f-ILD to improve access or ease of use and supporting behavior change through a health coach will have a measurable and sustained positive impact on patient well-being and quality of life as compared to no participation or non-use.
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
- 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
- •IInclusion Criteria:
- •F-ILD diagnosis, any disease subtype, active or prior medical treatment
- •>10% fibrosis on CT imaging
- •mMRC dyspnea score >1
- •All racial or ethnic categories, including non-English speakers (professional translators will be engaged to support screening, enrollment, and study participation)
排除标准
- •Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
- •Cognitive impairment or inability to understand and follow instructions
- •Traditional center-based PR completed within 3 months of initial study recruitment
- •Transition to hospice or end-of-life care at the time of screening
- •Acute exacerbation at the time of screening
结局指标
主要结局
King's Brief Interstitial Lung Disease (K- BILD)
时间窗: Baseline, end of intervention (3 months), and 3 months post-intervention
Respiratory-related quality of life questionnaire
Physical activity as measured by change in mean number of steps per day
时间窗: Baseline, end of intervention (3 months), and 3 months post-intervention
Mean number of steps as measured by Actigraph monitor over 5-7 days
次要结局
- Modified Medical Research Council (mMRC)(Baseline, end of intervention (3 months), and 3 months post-intervention)
- Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire(Baseline, end of intervention (3 months), and 3 months post-intervention)
- FACIT Fatigue Scale(Baseline, end of intervention (3 months), and 3 months post-intervention)
- Leicester Cough Questionnaire (LCQ)(Baseline, end of intervention (3 months), and 3 months post-intervention)