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

NCT06390345 | Recruiting DMC

• 2 other identifiers: 1766415TE-2022C3-30598
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• The SF-12 PCS

  The SF-12 PCS (Short Form-12, Physical Component Score) is a health-related quality of life measure that assesses general physical functioning and well-being. SF-12 PCS scores range from 0-100 with higher scores indicating better general physical health.

  1 year

Secondary Outcomes (24)

• PROMIS Sleep-related impairment

  1 year

• PROMIS Sleep-related impairment

  3 months

• SF-12 PCS

  3 months

• SF-12 MCS

  3 months

• SF-12 MCS

  1 year

Study Arms (2)

FOCuSEd Intervention

ACTIVE COMPARATOR

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

Other: FOCuSEd Integrated Intervention

Usual Care- Enhanced

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care

Interventions

FOCuSEd Integrated Intervention OTHER

Participants randomized to the intervention will receive an integrated telehealth-delivered, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity physical exercise. This intervention will include a "core curriculum" during the first 3 months that includes: 1) a 12-session video based program; 2) goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal; 3) lifestyle coaching; and 4) three tele-pulmonary rehab sessions and an additional 60-75 minutes of gradually increasing self-directed exercise per week. At the end of 3 months, we will offer to enter a recommendation for weight loss medications to intervention participants with a BMI of ≥ 27 kg/m2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach.

FOCuSEd Intervention

Enhanced Usual Care OTHER

Participants in the "enhanced" usual care group will be referred to MOVE! (VA's weight loss management program) and pulmonary rehabilitation in coordination with their primary care provider.

Usual Care- Enhanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Boise VA Medical Center

Boise, Idaho, 83702, United States

RECRUITING

Jesse Brown VA Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

RECRUITING

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

Mann-Grandstaff VA Medical Center

Spokane, Washington, 99205, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Overweight; Obesity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Central Study Contacts

Brianna Moss

CONTACT

206.277.4166; brianna.moss@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: data will be available after 2029 for at least 6 years.

Locations

US (5)