Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease
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About
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.
Full description
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.
Enrollment
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Inclusion and exclusion criteria
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)
Exclusion Criteria:
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
460 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Johanna Hoult, MS
Data sourced from clinicaltrials.gov
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