Promoting Activity After COPD Exacerbations, Aim 2 (PACE2)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in mean daily step counts
研究概览
简要总结
This randomized controlled pilot study involving patients with chronic obstructive pulmonary disease (COPD) recently discharged from the hospital will evaluate the feasibility and efficacy of a home-based mobile-health supported physical activity promotion program.
详细描述
Deconditioning is common in patients with chronic obstructive pulmonary disease (COPD) and has been associated with poor outcomes (e.g. difficulty breathing). Pulmonary rehabilitation (PR) initiated shortly after hospital discharge following a COPD exacerbation has been shown to improve some of these outcomes. However, for many patients, access to PR programs is limited due to environmental, physical, and psycho-social reasons. Home-based physical activity promotion, combined with education and social support, could help to overcome some barriers to access and have been shown to be effective in populations with mild to moderate COPD. However, home-based interventions have not been tested in patients recovering from COPD exacerbations, a group for whom solutions to safely promote physical activity are urgently needed. In PACE2 up to 64 adult participants with a physician diagnosis of COPD will be enrolled and randomized to one of two groups: physical activity promotion intervention or enhanced usual care. Participants will be enrolled while hospitalized and randomization will occur approximately 7 days after hospital discharge. All participants will be provided self-management educational materials and community resources both prior to hospital discharge and during a home visit shortly after hospital discharge. For the participants randomized to the intervention group, physical activity promotion will start following randomization and continue for 12 weeks. These participants will also receive a personalized plan to attend pulmonary rehabilitation, a guideline-recommended program for patients with COPD recovering from exacerbations. The primary endpoint will be the change in physical activity (mean daily step counts over 1 week) over time using repeated measures over the 12 weeks of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Allocation sequence will be concealed
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
- •Age 18 years or older;
- •Physician diagnosis of COPD;
- •Hospitalized as an inpatient, 23-hour observation, or clinical decision unit
- •Admitting respiratory conditions sensitive to the Centers for Medicare and Medicaid Services Hospital Readmission Reduction Program as listed below:
- •COPD exacerbation
- •Asthma/COPD overlap
- •Decompensated heart failure
- •Pneumonia
- •Chronic Airway Disease
排除标准
- •Physical inability to participate in a walking program;
- •Oxygen saturation <90% by pulse oximetry refractory to supplemental oxygen, or in a patient unable or unwilling to use supplemental oxygen;
- •Fall in the previous 6 months;
- •Resting electrocardiogram (ECG) with new ST changes or tachyarrhythmia;
- •Planned discharge home to hospice or to long term care facility/skilled nursing facility;
- •Life expectancy <3 months;
- •Medical contraindication to participating in a physical activity promotion program as determined by the inpatient treating clinician;
- •Unable to communicate in English;
- •Unable or declines to provide informed consent.
研究组 & 干预措施
PACE2 Intervention
All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity. In addition, participants randomized to the PACE2 intervention will receive written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.
干预措施: PACE2 Intervention (Other)
Enhanced Usual Care
All participants will receive usual healthcare as per their treating medical team and carry a pedometer for recording of physical activity.
结局指标
主要结局
Change in mean daily step counts
时间窗: 12 weeks
change in mean daily step counts (averaged over 1 week) over time using repeated measures over the 12 weeks of the study.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression(12 weeks)
- PROMIS Fatigue(12 weeks)
- PROMIS Emotional Distress - Anxiety(12 weeks)
- PROMIS Physical function(12 weeks)
研究者
Jerry Krishnan
Professor
University of Illinois at Chicago