Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06390345

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

Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2025-09-11

400

Participants Needed

5

Research Sites

217 weeks

Total Duration

On this page

Sponsors

S

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • COPD defined by airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry
  • At least 10 pack years history of tobacco use
  • Self-reported clinician diagnosis of OSA or presence of OSA on research HSAT
  • Body Mass Index (BMI) of 25 kg/m2 or higher
  • Symptoms of dyspnea with MMRC score of 1 or more
Not Eligible

You will not qualify if you...

  • Weight change greater than 15 pounds in the prior 3 months
  • Current active weight loss treatment including commercial programs, behavioral health or wellness programs, prescription weight loss medication in last 3 months, or scheduled bariatric surgery
  • Severe illness from any cause
  • Diagnosis of bulimia or history of purging behavior
  • Active enrollment in pulmonary rehabilitation
  • Safety or adherence concerns due to severe physical or mental health issues or life expectancy less than 12 months, including unstable cardiac arrhythmias, recent myocardial infarction or COPD exacerbation, poorly controlled angina, significant musculoskeletal issues, or need for supplemental oxygen 5 liters per minute or more at rest or exertion
  • Pregnant, lactating, or planning pregnancy during the study
  • Participation in other intervention studies
  • Prisoner status
  • Unable to complete surveys in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Boise VA Medical Center

Boise, Idaho, United States, 83702

Actively Recruiting

2

Jesse Brown VA Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

3

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States, 55417

Actively Recruiting

4

VA Puget Sound Health Care System

Seattle, Washington, United States, 98108

Actively Recruiting

5

Mann-Grandstaff VA Medical Center

Spokane, Washington, United States, 99205

Actively Recruiting

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Research Team

B

Brianna Moss

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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