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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based Pulmonary Rehabilitation with Health Coaching Group | Experimental | Twelve-week intervention with home-based pulmonary rehabilitation and health coaching. |
|
| Non-use Waitlist Control Observation Group | No Intervention | 12-week non-use usual care waitlist with transition to intervention group at the end of the observation period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Pulmonary Rehab | Behavioral | Participants are expected to engage in the home-based PR routine five to six days a week for the entire 12-week study period. The PR routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time is 24 minutes a day followed by a 4-minute mindful breathing meditation/cool down. Exercises may be modified or repeated according to baseline activity level and as conditioning improves. |
| Measure | Description | Time Frame |
|---|---|---|
| King's Brief Interstitial Lung Disease (K- BILD) | Respiratory-related quality of life questionnaire | Baseline, end of intervention (3 months), and 3 months post-intervention |
| Physical activity as measured by change in mean number of steps per day | Mean number of steps as measured by Actigraph monitor over 5-7 days | Baseline, end of intervention (3 months), and 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Medical Research Council (mMRC) | dyspnea scale | Baseline, end of intervention (3 months), and 3 months post-intervention |
| Living with Pulmonary Fibrosis (L-PF)-Symptoms and Impacts Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Utilization | Interval clinical status as reported or assessed in the medical record for clinic, urgent, emergency room visits, and hospitalizations, for all causes | Six months prior to enrollment, end of intervention (3 months), and 3 months post-intervention |
IInclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna Hoult, MS | Contact | 507-293-1989 | hoult.johanna@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Teng Moua | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Randomized waitlist control
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Respiratory-related quality of life questionnaire
| Baseline, end of intervention (3 months), and 3 months post-intervention |
| FACIT Fatigue Scale | Fatigue assessment questionnaire | Baseline, end of intervention (3 months), and 3 months post-intervention |
| Leicester Cough Questionnaire (LCQ) | Cough severity assessment questionnaire | Baseline, end of intervention (3 months), and 3 months post-intervention |
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |