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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a remote lifestyle and supervised exercise program improves quality of life compared with usual care with added referrals. It is for 400 adults who are overweight or obese and have both COPD, a lung disease that limits airflow, and OSA, which causes breathing to stop and start during sleep. Participants must receive primary care at one of five participating VA medical centers or their community clinics.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have COPD confirmed by a breathing test after taking medicine that opens the airways (FEV1/FVC below 0.70).
  • Have smoked at least 10 pack-years, such as 1 pack a day for 10 years.
  • Have sleep apnea diagnosed by a clinician, based on your report, or found on the study’s home sleep test.
  • Have a body mass index (BMI), a measure based on height and weight, of at least 25.
  • Have shortness of breath rated at least 1 on the study’s symptom scale.

Who can't join

  • Have gained or lost more than 15 pounds in the past 3 months.
  • Are in a weight loss program led by trained staff, have taken prescription weight loss medicine in the past 3 months, or have weight loss surgery scheduled.
  • Have a severe illness, or physical or mental health problems that make participation unsafe or hard to complete. This includes serious heart problems, a heart attack or COPD flare-up within the past month, problems that prevent exercise, needing oxygen at 5 or more liters per minute, or an expected lifespan under 12 months.
  • Have bulimia, an eating disorder, or a history of purging, such as making yourself vomit to control weight.
  • Are already in pulmonary rehabilitation, a supervised exercise and education program for lung disease, or another study testing a treatment or program.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Are a prisoner.
  • Cannot complete surveys in English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * COPD: Defined by presence of airflow obstruction (FEV1/FVC \< 0.70) on post-bronchodilator spirometry * ≥10 pack year history of tobacco use * Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT) * BMI ≥ 25 kg/m2 * Symptoms of dyspnea defined by MMRC score of ≥1 Exclusion Criteria: * Self-report of weight change \>15 lbs. during prior 3 months * Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery. * Severe illness from any cause * Diagnosis of bulimia or history of purging behavior * Active enrollment in pulmonary rehabilitation * Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy \< 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion. * Pregnant, lactating, or planning to become pregnant during the study period * Participation in other intervention studies. * Prisoner * Unable to complete surveys in English

Study sites (5)

ID

  • Boise VA Medical Center · Boise, ID 83702Brianna Moss · Study contact · brianna.moss@va.govPaula Carvalho, MD · Principal investigatorWilliam Weppner, MD · Principal investigatorMore trials in Boise

IL

  • Jesse Brown VA Medical Center · Chicago, IL 60612Brianna Moss · Study contact · brianna.moss@va.govMin Joo, MD · Principal investigatorStephanie LaBedz, MD · Principal investigatorMore trials in Chicago

MN

  • Minneapolis VA Health Care System · Minneapolis, MN 55417Brianna Moss · Study contact · brianna.moss@va.govCharles Billington, MD · Principal investigatorBenjamin Henkle, MD · Principal investigatorMore trials in Minneapolis

WA