Improving health in patients with COPD and sleep apnea through telehealth lifestyle changes
Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
This study is testing a telehealth program to see if it can help overweight and obese veterans with COPD and sleep apnea improve their health through lifestyle changes and support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seattle Institute for Biomedical and Clinical Research Academic / other |
| Locations | 5 sites (Boise, Idaho and 4 other locations) |
| Trial ID | NCT06390345 on ClinicalTrials.gov |
What this trial studies
This study tests a telehealth intervention aimed at improving the health of overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). It involves a randomized trial where participants will receive either a multi-component telehealth intervention or enhanced usual care. The intervention includes a self-directed lifestyle program and supervised pulmonary rehabilitation, with a follow-up recommendation for weight management medications after three months. The study will take place across five Department of Veterans Affairs medical centers.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese patients with a diagnosis of COPD and OSA, aged 18 and older.
Not a fit: Patients who have recently undergone significant weight changes or are currently enrolled in weight loss treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to significant improvements in the health and quality of life for patients with COPD and OSA.
How similar studies have performed: Other studies have shown promise in using telehealth interventions for chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Boise, Idaho and 4 other locations
- Boise VA Medical Center — Boise, Idaho, United States (Recruiting)
- Jesse Brown VA Medical Center — Chicago, Illinois, United States (Recruiting)
- Minneapolis VA Health Care System — Minneapolis, Minnesota, United States (Recruiting)
- VA Puget Sound Health Care System — Seattle, Washington, United States (Recruiting)
- Mann-Grandstaff VA Medical Center — Spokane, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Brianna Moss
- Email: brianna.moss@va.gov
- Phone: 206.277.4166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.