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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
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.
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.
Boise VA Medical Center
Boise, Idaho, United States
RECRUITINGJesse Brown VA Medical Center
Chicago, Illinois, United States
RECRUITINGMinneapolis VA Health Care System
Minneapolis, Minnesota, United States
RECRUITINGVA Puget Sound Health Care System
Seattle, Washington, United States
RECRUITINGMann-Grandstaff VA Medical Center
Spokane, Washington, United States
RECRUITINGThe 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.
Time frame: 1 year
PROMIS Sleep-related impairment
The Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment, which is a worse outcome.
Time frame: 1 year
PROMIS Sleep-related impairment
The Patient Reported Outcomes Measurement Information System (PROMIS) -Sleep Related Impairment Survey. The minimum value for PROMIS Sleep Related Impairment is a T-score of 30.0, the maximum is a T-score of 80.1, and a greater value indicates greater sleep related impairment, which is a worse outcome.
Time frame: 3 months
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.
Time frame: 3 months
SF-12 MCS
The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health.
Time frame: 3 months
SF-12 MCS
The SF-12 MCS (Short Form-12, Mental Component Score) is a health-related quality of life measure that assesses general mental health status. SF-12 MCS scores range from 0-100 with higher scores indicating better general physical health.
Time frame: 1 year
PROMIS Sleep Disturbance
The Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance, which is a worse outcome.
Time frame: 3 months
PROMIS Sleep Disturbance
The Patient Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Survey. The minimum value for PROMIS Sleep Disturbance is a T-score of 28.9, the maximum is a T-score of 76.5, and a greater value indicates greater sleep disturbance, which is a worse outcome.
Time frame: 1 year
COPD exacerbation or death
Proportion of patients with COPD exacerbation or Death (composite outcome) \[ Time Frame: 3 months after randomization \]
Time frame: 3 months
COPD exacerbation or death
Proportion of patients with COPD exacerbation or Death (composite outcome) \[ Time Frame: 12 months after randomization \]
Time frame: 1 year
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.
Time frame: 3 months
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome.
Time frame: 1 year
Weight Loss
Total (kg)
Time frame: 3 months
Weight Loss
Total (kg)
Time frame: 1 year
Clinically Significant Weight Loss
5% weight loss met
Time frame: 3 months
Clinically Significant Weight Loss
5% weight loss met
Time frame: 1 year
Cardiovascular risk score
Non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease, which is a worse outcome.
Time frame: 3 months
Cardiovascular risk score
Non-laboratory Framingham algorithm. The minimum value in this risk score is -2, the maximum is 32, and a higher value indicates greater risk of cardiovascular disease, which is a worse outcome.
Time frame: 1 year
Social Support
Social Support for diet and exercise scales
Time frame: 3 months
Social Support
Social Support for diet and exercise scales
Time frame: 1 year
Depression
PHQ-8 Depression scale
Time frame: 3 months
Depression
PHQ-8 Depression scale
Time frame: 1 year
Strength and endurance
30 second chair stand
Time frame: 3 months
Strength and endurance
30 second chair stand
Time frame: 1 year
OSA Severity
Home-Sleep Apnea Testing: Respiratory Event Index
Time frame: 1 Year
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