Clinical trial NCT06751069: Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease
Official title: Home-based Pulmonary Rehabilitation and Health Coaching in Patients With Fibrotic Interstitial Lung Disease: A Prospective Pragmatic Randomized Waitlist-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Fibrosis
Lung Interstitial Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-12-27
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized waitlist control
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: King's Brief Interstitial Lung Disease (K- BILD)
timeFrame: Baseline, end of intervention (3 months), and 3 months post-intervention
measure: Physical activity as measured by change in mean number of steps per day
timeFrame: Baseline, end of intervention (3 months), and 3 months post-intervention
Secondary outcomes:
measure: Modified Medical Research Council (mMRC)
timeFrame: Baseline, end of intervention (3 months), and 3 months post-intervention
measure: Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire
timeFrame: Baseline, end of intervention (3 months), and 3 months post-intervention
measure: FACIT Fatigue Scale
timeFrame: Baseline, end of intervention (3 months), and 3 months post-intervention
measure: Leicester Cough Questionnaire (LCQ)
timeFrame: Baseline, end of intervention (3 months), and 3 months post-intervention
Other outcomes:
measure: Healthcare Utilization
timeFrame: Six months prior to enrollment, end of intervention (3 months), and 3 months post-intervention
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Teng Moua
role: PRINCIPAL_INVESTIGATOR
References: