Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

Recruiting now · Not applicable

Conditions studied: Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea, Overweight and Obesity

In brief

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.

Key facts

Study ID: NCT06390345
Run by: Seattle Institute for Biomedical and Clinical Research
People needed: 400
Starts: 2024-07-29
Expected to finish: 2028-10-01
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry
≥10 pack year history of tobacco use
Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)
BMI ≥ 25 kg/m2
Symptoms of dyspnea defined by MMRC score of ≥1

You may not qualify if…

Self-report of weight change >15 lbs. during prior 3 months
Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.
Severe illness from any cause
Diagnosis of bulimia or history of purging behavior
Active enrollment in pulmonary rehabilitation
Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy < 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.
Pregnant, lactating, or planning to become pregnant during the study period
Participation in other intervention studies.
Prisoner
Unable to complete surveys in English

Where it is running

Boise VA Medical Center — Boise, Idaho, United States (enrolling)
Jesse Brown VA Medical Center — Chicago, Illinois, United States (enrolling)
Minneapolis VA Health Care System — Minneapolis, Minnesota, United States (enrolling)
VA Puget Sound Health Care System — Seattle, Washington, United States (enrolling)
Mann-Grandstaff VA Medical Center — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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