Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 306
- 试验地点
- 4
- 主要终点
- Change Chronic Respiratory Questionnaire Physical and Emotional (CRQ-SAS) summary scores
研究概览
简要总结
The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years of age or older
- •Physician-diagnosed COPD
- •Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10
- •mMRC score>=1
- •English Speaking
排除标准
- •Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
- •Cognitive impairment or inability to understand and follow instructions.
- •Patients with no COPD symptom burden, no breathlessness (mMRC score 0), as based on our previous studies they usually perceive no benefit from PR and do not have compliance with PR.
- •Traditional center-based PR was completed within 3 months of initial study recruitment.
- •Transition to hospice or end-of-life care at the time of screening.
- •Acute exacerbation at the time of screening.
研究组 & 干预措施
Treatment Group
Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.
干预措施: Pulmonary rehabilitation program (Behavioral)
Waitlist Control
Subjects randomized to the waitlist control (usual care) arm will be offered the home-based pulmonary rehabilitation intervention after completing the 12-week control period.
干预措施: Pulmonary rehabilitation program (Behavioral)
结局指标
主要结局
Change Chronic Respiratory Questionnaire Physical and Emotional (CRQ-SAS) summary scores
时间窗: Baseline, 3 months
The Chronic Respiratory Disease Questionnaire is a 20 item questionnaire assessing the quality of life for patients with chronic obstructive pulmonary disease (COPD). The CRQ covers four domains: dyspnea, fatigue, emotional function, and mastery. Questions are scored on a 7-point Likert scale, with 1 representing 'All of the time' and 7 representing 'None of the time'. Higher scores indicate better outcomes.
次要结局
未报告次要终点
研究者
Roberto P. Benzo
Principal Investigator
Mayo Clinic