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

Last updated: September 4, 2025
Sponsor: Seattle Institute for Biomedical and Clinical Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Obesity

Diabetes Prevention

Treatment

Enhanced Usual Care

FOCuSEd Integrated Intervention

Clinical Study ID

NCT06390345
1766415
TE-2022C3-30598
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) onpost-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

Exclusion Criteria:

  • Self-report of weight change >15 lbs. during prior 3 months

  • Current active weight loss treatment, including: 1) research-based commercial weightloss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2)other weight loss or related behavioral health or wellness programs led by trainedpersonnel (professional or lay) in the local community; 3) prescription weight lossmedication 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 orlife expectancy < 12 months. These include but may not be limited to: unstablecardiac arrhythmias, active or recent (within one month) myocardial infarction,active or recent (within one month) COPD exacerbation, angina not well-controlledwith medication, significant musculoskeletal comorbidities or physical infirmitiesthat preclude participation in an exercise program, and the need for supplementaloxygen ≥ 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

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Enhanced Usual Care
Phase:
Study Start date:
July 29, 2024
Estimated Completion Date:
October 01, 2028

Connect with a study center

  • Boise VA Medical Center

    Boise, Idaho 83702
    United States

    Site Not Available

  • Boise VA Medical Center

    Boise 5586437, Idaho 5596512 83702
    United States

    Active - Recruiting

  • Jesse Brown VA Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Jesse Brown VA Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Minneapolis VA Health Care System

    Minneapolis 5037649, Minnesota 5037779 55417
    United States

    Active - Recruiting

  • VA Puget Sound Health Care System

    Seattle, Washington 98108
    United States

    Site Not Available

  • Mann-Grandstaff VA Medical Center

    Spokane, Washington 99205
    United States

    Site Not Available

  • VA Puget Sound Health Care System

    Seattle 5809844, Washington 5815135 98108
    United States

    Active - Recruiting

  • Mann-Grandstaff VA Medical Center

    Spokane 5811696, Washington 5815135 99205
    United States

    Active - Recruiting

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