Pilot Study of Rehabilitation in Safety-net Settings for Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change from Baseline 6 Minute Walk Test at End of Intervention
研究概览
简要总结
This study will examine COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group and home exercise, education, and social support can improve symptoms and increase physical activity in participants with COPD who receive care within a 'safety-net' healthcare system (e.g. County Hospital). Half of the participants will also receive an adherence strategy targeted at addressing unmet social needs, while the other half will undergo the intervention without the adherence strategy.
详细描述
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.
COPD Wellness, a 10-week low-intensity pulmonary rehabilitation program consisting of group and home exercise, education, and social support, was developed to address this gap. This intervention is targeted at patients with moderate to severe COPD (GOLD Class B-D) who receive care through a safety-net health system. To be impactful, risk factors for low adherence include both disease severity and socio-environmental factors, must be addressed. As merely having a pulmonary rehabilitation program will not automatically lead to improved outcomes.
As part of this study, an adherence strategy targeted at addressing unmet social needs to improve health will also be implemented. A Health Advocates program that links social needs screening with a tiered referral and linkage process to appropriate resources will be tested to see if adherence to COPD Wellness (exercise intervention) improves by addressing competing non-medical stressors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The principal investigator and outcome assessor will be masked to when the participant completes the intervention and to whether or not they received the Health Advocates adherence strategy.
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Are greater than or equal to 40 years
- •Diagnosis: COPD Gold Stage Class B-D (symptomatic disease), COPD/Asthma overlap with symptoms
- •Language: English
- •Care Center: ZSFG, Community Health Center clinics, Federally Qualified Health Centers
- •Availability: Able to participate in a 10-week, weekly course at the weekly scheduled time (can defer x 1)
排除标准
- •Planning to move out of the area within the next year
- •Eligible for and desire to go to full intensity pulmonary rehabilitation. Participant has Medicare Part A and B OR have San Francisco Health Plan. For those that met these criteria, we will assist with referral to program
- •Resides in any kind of long-term care facilities that is NOT Laguna Honda or the Mental Health Rehabilitation Facility
- •Has a diagnosis of interstitial lung disease, pulmonary fibrosis, or cystic fibrosis
- •Active, chronic lung infection, such as tuberculosis
- •A history of a pulmonary embolism in the year (12 months) prior to recruitment
- •History of a myocardial infarction in the year (12 months) prior to recruitment
- •In the 12 weeks prior to recruitment, has had history of unstable heart disease (including valve disease), heart failure, or uncontrolled irregular heart beat
- •Potential participants who have had the following will be re-assess for eligibility 6 weeks after the initial assessment:
- •A pulmonary exacerbation or worsening of COPD/Asthma symptoms in the past 6 weeks
- •History of an upper respiratory infection in the past 6 weeks
- •History of an eye, chest, or abdominal surgery within the past 6 weeks
研究组 & 干预措施
COPD Wellness With Health Advocate
This arm will be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD with an additional assignment of a health advocate to address unmet social needs as an adherence strategy.
干预措施: COPD Wellness (Behavioral)
COPD Wellness With Health Advocate
This arm will be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD with an additional assignment of a health advocate to address unmet social needs as an adherence strategy.
干预措施: Health Advocate (Behavioral)
COPD Wellness
This arm will only be given low-intensity pulmonary rehabilitation, COPD Wellness, for individuals with moderate-to-severe COPD.
干预措施: COPD Wellness (Behavioral)
结局指标
主要结局
Change from Baseline 6 Minute Walk Test at End of Intervention
时间窗: End of Intervention, an average of 4 months
Standardized test to measure distance walked in 6 minutes
Change from Baseline COPD Assessment Test (CAT) at End of Intervention
时间窗: End of Intervention, an average of 4 months
Questionnaire assessing COPD symptoms and quality of life
次要结局
- Change from baseline D-12 evaluation at end of intervention(End of Intervention, an average of 4 months)
- Change in baseline Patient Health Questionnaire (PHQ-)8 at End of Intervention(End of Intervention, an average of 4 months)
- Adherence(Assessed during 10-week COPD Wellness Intervention)
- Change in baseline Smoking status at end of intervention(End of Intervention, an average of 4 months)
- Change from Baseline 6 Minute Walk Test at 12 months(Baseline and 12 months)
- Change from Baseline number of exacerbations of COPD at End of Intervention(End of Intervention, an average of 4 months)
- Change from Baseline number of exacerbations of COPD at 12 months(12 months)
- Change from Baseline COPD Assessment Test (CAT) at 12 months(Baseline, 12 months)
- Change in baseline Smoking status at 12 months(12 months)
- Change from baseline D-12 evaluation at 12 months(12 months)