Clinical trial NCT06390345: Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
Official title: Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Obstructive Sleep Apnea
Overweight and Obesity
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-04-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 ≥2

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

Primary outcomes:
measure: The SF-12 PCS
timeFrame: 1 year
Secondary outcomes:
measure: PROMIS Sleep-related impairment
timeFrame: 1 year
measure: PROMIS Sleep-related impairment
timeFrame: 3 months
measure: SF-12 PCS
timeFrame: 3 months
measure: SF-12 MCS
timeFrame: 3 months
measure: SF-12 MCS
timeFrame: 1 year
measure: PROMIS Sleep Disturbance
timeFrame: 3 months
measure: PROMIS Sleep Disturbance
timeFrame: 1 year
measure: COPD exacerbation or death
timeFrame: 3 months
measure: COPD exacerbation or death
timeFrame: 1 year
measure: COPD Assessment Test (CAT)
timeFrame: 3 months
measure: COPD Assessment Test (CAT)
timeFrame: 1 year
measure: Weight Loss
timeFrame: 3 months
measure: Weight Loss
timeFrame: 1 year
measure: Clinically Significant Weight Loss
timeFrame: 3 months
measure: Clinically Significant Weight Loss
timeFrame: 1 year
measure: Cardiovascular risk score
timeFrame: 3 months
measure: Cardiovascular risk score
timeFrame: 1 year
measure: Social Support
timeFrame: 3 months
measure: Social Support
timeFrame: 1 year
measure: Depression
timeFrame: 3 months
measure: Depression
timeFrame: 1 year
measure: Strength and endurance
timeFrame: 3 months
measure: Strength and endurance
timeFrame: 1 year
measure: OSA Severity
timeFrame: 1 Year
Other outcomes:
Locations:
city: Boise
country: United States
facility: Boise VA Medical Center
state: Idaho
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
city: Spokane
country: United States
facility: Mann-Grandstaff VA Medical Center
state: Washington
Study officials:
References: