Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 387
- 试验地点
- 6
- 主要终点
- Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US, disproportionately affects low socioeconomic communities. While few interventions effectively modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable exception. However, implementation of this resource-intensive program in real-life settings, and in particular, for underserved communities, has proven to be challenging. Safety-net centers that serve primarily under-insured populations lack financial resources to provide pulmonary rehabilitation.
The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.
详细描述
The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The masked research coordinator will administer questionnaires and conduct clinical assessments at all study visits. Condition assignment will remain masked through data analysis and interpretation from study investigators and any team members involved in the data analysis. Furthermore, the COPD Wellness Coach leading weekly sessions, in addition to the research coordinator collecting endpoint measurements, will be masked to participant group status.
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Willingness to participate in the COPD Wellness program
- •40 to 90 years old
- •English or Spanish speaking
- •Physician-diagnosed COPD
- •Spirometry-confirmed FEV1/FVC ratio <= 0.7 and FEV1% predicted <80% based on GLI-O prediction equation
- •COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy
- •Currently prescribed COPD medication(s)
- •Ability to exercise with lower extremities
- •No COPD exacerbations for ≥ 6 weeks
- •Currently receiving care within SFHN
- •Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC)
排除标准
- •Pregnancy
- •Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating
- •Unstable cardiovascular disease (includes recent [<6 months] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure)
- •Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist)
- •Transmittable pulmonary infection (tuberculosis, COVID19)
- •Participated in pulmonary rehabilitation in the past 12-months
- •COPD exacerbation in the past 6 weeks
- •Activities restrictions that limit one's ability to engage in moderate physical activity
- •Other diagnosis or condition that carry a prognosis of death within the next year
结局指标
主要结局
Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit
时间窗: 3-month (End of intervention) visit
Standardized validated test to measure distance walked in 6 minutes
次要结局
- Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention(Baseline, 6-month, and 9-month visit following end-of-intervention)
- Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit(Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit)
- Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit(Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit)
- Health System Adoption of intervention for patients referred(Baseline, 24-months after study implementation)
- Intervention Adherence at End-of-intervention (3 month)(Assessed during 10-week COPD Wellness Intervention)
- Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up(Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit)
- Health System Proportion of patients referred to the intervention(Baseline, 24-months after study implementation)
- Healthy System Maintenance of intervention from start of study to end of study activities(Baseline, Year 3 of study period (end of study activities))