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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Idaho
Boise VA Medical Center
RECRUITING
Boise
Illinois
Jesse Brown VA Medical Center
RECRUITING
Chicago
Minnesota
Minneapolis VA Health Care System
RECRUITING
Minneapolis
Washington
VA Puget Sound Health Care System
RECRUITING
Seattle
Mann-Grandstaff VA Medical Center
RECRUITING
Spokane
Contact Information
Primary
Brianna Moss
brianna.moss@va.gov
206.277.4166
Time Frame
Start Date: 2024-07-29
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 400
Treatments
Active_comparator: FOCuSEd Intervention
Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.
Active_comparator: Usual Care- Enhanced
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.
Sponsors
Leads: Seattle Institute for Biomedical and Clinical Research
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov