Background and Significance: Nearly 50% of the estimated 24 million Americans with chronic obstructive pulmonary disease (COPD) also have obstructive sleep apnea (OSA). When combined, these conditions reinforce shortness of breath, reduce exercise ability, and impair quality of life. Excess weight worsens these symptoms, impairing patients’ ability to breathe, exercise, and perform usual activities. Unfortunately, few patients receive effective services to help them lose weight. One reason for this is the competing demands that limit capacity for weight loss counseling and referral by primary care providers. We need to find additional resources and strategies to help clinicians aid patients in their efforts to lose weight and improve their health.
Our research team developed a remotely delivered, self-directed lifestyle intervention that improved shortness of breath, exercise ability, quality of life, and helped patients with COPD lose weight. But these changes were small, suggesting it is necessary to provide additional support. In this study, we will combine the life-style intervention with telehealth-delivered pulmonary rehabilitation, which provides supervised exercise along with COPD education and skills to help patients cope with shortness of breath. Combining these two programs may help patients have less symptoms and improve their ability to exercise. However, many patients may also need medication to help them lose weight. Research to date suggests that combining these approaches into one intervention may be the best way for patients with COPD and OSA to lose weight, feel better, and be able to do more. As we design and test this telehealth intervention, we want to make sure that it works for all patients, including those that are older or live in rural areas.
The overall goals of our study are:
Aim 1: Test the effectiveness of a telehealth-delivered lifestyle and structured exercise intervention that incorporates a stepped-care approach to improve patient-centered outcomes among overweight and obese patients with COPD and OSA.
Aim 2: Examine heterogeneity in effectiveness of the intervention among populations at risk of poor access to healthcare (e.g., patients who are elderly, those dwelling in rural communities).
Aim 3: Evaluate implementation of our telehealth-delivered lifestyle and exercise intervention using outcomes defined by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework.
Study Description: We will evaluate our telehealth intervention among patients with COPD, OSA and excess weight. We will include patients receiving primary care at five Department of Veterans Affairs (VA) medical centers. We will recruit 400 patients with COPD and OSA, a BMI ≥ 25 kg/m2, and shortness of breath. We will aim to over-recruit women and minorities to ensure that we have enough participation from these groups. We will randomize patients to our intervention or “enhanced” usual care. Participants randomized to the intervention will receive an integrated self-directed, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity exercise.
For the first 3 months, the program will include:
- Twelve weekly videos on healthy eating and exercise.
- Goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal.
- Lifestyle coaching.
- Three supervised tele-pulmonary rehabilitation sessions and an additional 60-75 minutes of gradually increasing exercise per week.
At the end of 3 months, we will prescribe Semaglutide for participants with a BMI of ≥ 27 kg/m2 not achieving a goal of 5% weight loss. In the post-core period (months 4-12), participants will have as-needed access to the lifestyle coach. Participants in the “enhanced” usual care group will be referred to MOVE! (VA’s weight loss management program) and pulmonary rehabilitation. Follow-up will occur at virtual visits at 3- and 12-months post-randomization. Our primary outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary outcomes will include other measures of quality of life (including sleep-related impairment), sleep disturbance, measures of COPD and OSA severity, depression, social support, weight loss and cardiovascular risk. We will also assess the reach, uptake, and implementation of the intervention. We will work with Patient Investigators, the COPD Foundation, payors, and VA national leaders to perform this study. The results will provide information to health systems and patients about how well the intervention works to improve the lives and health of patients with OSA, COPD and excess weight.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.