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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Summary

We will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with COPD and OSA. We will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. We 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, we 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. Our 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, we will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06390345
Study type Interventional
Source Seattle Institute for Biomedical and Clinical Research
Contact Brianna Moss
Phone 206.277.4166
Email brianna.moss@va.gov
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date October 1, 2028
View Details
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