Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- The SF-12 PCS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •Unable to complete surveys in English
研究组 & 干预措施
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.
干预措施: FOCuSEd Integrated Intervention (Other)
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.
干预措施: Enhanced Usual Care (Other)
结局指标
主要结局
The SF-12 PCS
时间窗: 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.
次要结局
- PROMIS Sleep-related impairment(3 months)
- SF-12 PCS(3 months)
- Cardiovascular risk score(1 year)
- Weight Loss(1 year)
- Strength and endurance(1 year)
- SF-12 MCS(1 year)
- Social Support(1 year)
- Depression(1 year)
- PROMIS Sleep Disturbance(1 year)
- COPD exacerbation or death(1 year)
- COPD Assessment Test (CAT)(1 year)
- OSA Severity(1 Year)
- Clinically Significant Weight Loss(1 year)