Telehealth Lifestyle and Exercise Program for Overweight Adults With COPD and Sleep Apnea

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have both COPD and sleep apnea, are overweight or obese, and are treated at a VA medical center. It tests a telehealth lifestyle and exercise program.

Age

18 years or older

Sex

All sexes can join

Disease stage

COPD with airflow blockage on a breathing test (FEV1/FVC < 0.70) after a bronchodilator, plus obstructive sleep apnea (OSA). Some shortness of breath is needed (MMRC score of ≥1).

Earlier treatment

People in a weight loss program, on prescription weight loss medication within the last 3 months, or scheduled for bariatric surgery cannot join. People currently in pulmonary rehabilitation cannot join.

Biomarker or test result

Smoking history of at least 10 pack years. BMI of 25 kg/m2 or more. OSA that the person reports a clinician diagnosed, or that a research home sleep test finds.

Main reasons for not taking part

• Weight change of more than 15 lbs (7 kg). in the last 3 months
• Severe illness from any cause
• Bulimia or a history of purging
• Recent heart attack or COPD flare-up (within one month), or unstable heart rhythm
• Pregnant, breastfeeding, or planning pregnancy during the study

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• FOCuSEd InterventionExisting treatment, for comparison

  Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.

  Treatment: FOCuSEd Integrated Intervention

• Usual Care- EnhancedExisting treatment, for comparison

  For participants in 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.

  Treatment: Enhanced Usual Care