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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jul 29, 2024

Status verified

Sep 2025

Primary completion

Jul 1, 2028

Completion

Oct 1, 2028

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

The SF-12 PCS [ Time Frame: 1 year ]

Central Contacts

• Brianna Moss
  206.277.4166
  [email protected]

Locations (5)

Find similar trials in Boise, ID

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