Actively Recruiting
Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2025-09-11
400
Participants Needed
5
Research Sites
217 weeks
Total Duration
On this page
Sponsors
S
Seattle Institute for Biomedical and Clinical Research
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.
CONDITIONS
Official Title
Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- COPD defined by airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry
- At least 10 pack years history of tobacco use
- Self-reported clinician diagnosis of OSA or presence of OSA on research HSAT
- Body Mass Index (BMI) of 25 kg/m2 or higher
- Symptoms of dyspnea with MMRC score of 1 or more
You will not qualify if you...
- Weight change greater than 15 pounds in the prior 3 months
- Current active weight loss treatment including commercial programs, behavioral health or wellness programs, prescription weight loss medication in last 3 months, or scheduled bariatric surgery
- Severe illness from any cause
- Diagnosis of bulimia or history of purging behavior
- Active enrollment in pulmonary rehabilitation
- Safety or adherence concerns due to severe physical or mental health issues or life expectancy less than 12 months, including unstable cardiac arrhythmias, recent myocardial infarction or COPD exacerbation, poorly controlled angina, significant musculoskeletal issues, or need for supplemental oxygen 5 liters per minute or more at rest or exertion
- Pregnant, lactating, or planning pregnancy during the study
- Participation in other intervention studies
- Prisoner status
- Unable to complete surveys in English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Boise VA Medical Center
Boise, Idaho, United States, 83702
Actively Recruiting
2
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
4
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Actively Recruiting
5
Mann-Grandstaff VA Medical Center
Spokane, Washington, United States, 99205
Actively Recruiting
Research Team
B
Brianna Moss
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here