RecruitingNot ApplicableNCT06390345

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

Sponsor

Seattle Institute for Biomedical and Clinical Research

Enrollment

400 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease Obstructive Sleep Apnea Overweight and Obesity

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a telehealth-based program combining lifestyle changes and exercise can improve breathing and daily function in people who have both COPD (a chronic lung disease) and sleep apnea (OSA) at the same time. **You may be eligible if...** - You have been diagnosed with COPD confirmed by a breathing test - You have a history of at least 10 pack-years of tobacco use - You have been told you have sleep apnea (or it is detected during the study) - Your BMI is 25 or higher (overweight or obese) - You experience shortness of breath with daily activities **You may NOT be eligible if...** - You have lost or gained more than 15 pounds in the past 3 months - You are currently in a weight loss program or taking weight loss medications - You are currently in pulmonary rehabilitation - You are pregnant or planning to become pregnant - You have an unstable heart condition, recent heart attack, or need high-flow oxygen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERFOCuSEd Integrated Intervention

Participants randomized to the intervention will receive an integrated telehealth-delivered, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity physical exercise. This intervention will include a "core curriculum" during the first 3 months that includes: 1) a 12-session video based program; 2) goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal; 3) lifestyle coaching; and 4) three tele-pulmonary rehab sessions and an additional 60-75 minutes of gradually increasing self-directed exercise per week. At the end of 3 months, we will offer to enter a recommendation for weight loss medications to intervention participants with a BMI of ≥ 27 kg/m2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach.

OTHEREnhanced Usual Care

Participants in the "enhanced" usual care group will be referred to MOVE! (VA's weight loss management program) and pulmonary rehabilitation in coordination with their primary care provider.