Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lung Fibrosis
- Sponsor
- Mayo Clinic
- Enrollment
- 460
- Locations
- 4
- Primary Endpoint
- King's Brief Interstitial Lung Disease (K- BILD)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Detailed 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.
Investigators
Teng Moua
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion 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
Outcomes
Primary Outcomes
King's Brief Interstitial Lung Disease (K- BILD)
Time Frame: 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
Time Frame: Baseline, end of intervention (3 months), and 3 months post-intervention
Mean number of steps as measured by Actigraph monitor over 5-7 days
Secondary Outcomes
- 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)