Chronic Obstructive Pulmonary Disease, Obstructive Sleep Apnea, Overweight and Obesity
Conditions
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.
Interventions
OTHERFOCuSEd Integrated Intervention
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.
OTHEREnhanced Usual Care
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.
Sponsors
Seattle Institute for Biomedical and Clinical Research
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The SF-12 PCS | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Sleep-related impairment | 1 year | 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. |
| SF-12 PCS | 3 months | 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. |
| SF-12 MCS | 3 months | 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. |
| PROMIS Sleep Disturbance | 3 months | 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. |
| COPD exacerbation or death | 3 months | Proportion of patients with COPD exacerbation or Death (composite outcome) \[ Time Frame: 3 months after randomization \] |
| COPD Assessment Test (CAT) | 3 months | The COPD Assessment Test (CAT) ranges from a minimum of 0 to 40, with higher score comprising a worse outcome. |
| Weight Loss | 3 months | Total (kg) |
| Clinically Significant Weight Loss | 3 months | 5% weight loss met |
| Cardiovascular risk score | 3 months | 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. |
| Social Support | 3 months | Social Support for diet and exercise scales |
| Depression | 3 months | PHQ-8 Depression scale |
| Strength and endurance | 3 months | 30 second chair stand |
| OSA Severity | 1 Year | Home-Sleep Apnea Testing: Respiratory Event Index |
Countries
United States
Contacts
CONTACTBrianna Moss
Outcome results
None listed