Home-based pulmonary rehabilitation and health coaching for lung fibrosis patients
Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
This study tests whether a home-based rehab program with health coaching can help people with lung fibrosis feel better and be more active compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 4 sites (Scottsdale, Arizona and 3 other locations) |
| Trial ID | NCT06751069 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a home-based pulmonary rehabilitation program combined with health coaching on the quality of life and physical activity of patients suffering from fibrotic interstitial lung disease (f-ILD). The study compares this intervention to usual care, focusing on improving access to rehabilitation for patients who may not be able to participate in traditional center-based programs. The primary hypothesis is that this modified approach will lead to significant improvements in patient-reported outcomes related to respiratory health and overall well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with fibrotic interstitial lung disease who have a significant level of fibrosis and experience some degree of dyspnea.
Not a fit: Patients who are unable to walk due to orthopedic, neurologic, or cardiac limitations, or those in hospice care, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life and physical activity levels for patients with fibrotic interstitial lung disease.
How similar studies have performed: Other studies have shown positive outcomes with home-based pulmonary rehabilitation, suggesting that this approach may be effective for similar patient populations.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Scottsdale, Arizona and 3 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Teng Moua — Mayo Clinic
- Study coordinator: Johanna Hoult, MS
- Email: hoult.johanna@mayo.edu
- Phone: 507-293-1989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.