Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
Start Date
7/29/2024
Completion Date
10/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
FOCuSEd Integrated Intervention
Enhanced Usual Care
Conditions
Locations
Boise VA Medical Center
Boise, Idaho 83702
United States
Jesse Brown VA Medical Center
Chicago, Illinois 60612
United States
Minneapolis VA Health Care System
Minneapolis, Minnesota 55417
United States
VA Puget Sound Health Care System
Seattle, Washington 98108
United States
Mann-Grandstaff VA Medical Center
Spokane, Washington 99205
United States