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

Study acronym: FOCuSEd
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 2 versions Re-verified since Sep 4, 2025, no change to tracked fieldsv6-v7
  2. Minor Eligibility criteria revisedv5
  3. Minor Site details revised at 5 of 5 sitesv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 3, 2024 to Jul 29, 2024
    • Site details revised at 5 of 5 sites
    • Eligibility criteria shortened, about 4 words
    v3
  5. Notable Start date: May 1, 2024 to Jul 3, 2024
    • Primary endpoint revised
    • Secondary endpoints revised (24)
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06390345
Lead Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)
Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea, Overweight and Obesity
Related terms Obesity, Overweight, Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov