EPIC 项目（使慢性阻塞性肺病患者实现独立）：一项针对老年慢性阻塞性肺病患者及其家庭照顾者的电话、老年病学-姑息治疗护士辅导的混合有效性-实施试点随机对照试验的研究方案。
Project EPIC (Empowering People to Independence in COPD): Study protocol for a hybrid effectiveness-implementation pilot randomized controlled trial of telephonic, geriatrics-palliative care nurse-coaching in older adults with COPD and their family caregivers.
机构信息
School of Nursing, University of Alabama at Birmingham, Birmingham, AL, United States of America.
School of Nursing, University of Alabama at Birmingham, Birmingham, AL, United States of America; Center for Palliative and Supportive Care, University of Alabama at Birmingham, Birmingham, AL, United States of America.
出版信息
Contemp Clin Trials. 2024 May;140:107487. doi: 10.1016/j.cct.2024.107487. Epub 2024 Mar 6.
BACKGROUND
EPIC (Empowering People to Independence in COPD) is a geriatric-palliative care telephonic, nurse coach intervention informed by Baltes' Theory of Successful Aging and adapted from the ENABLE (Educate, Nurture, Advise, Before Life Ends) intervention. EPIC, focused on improving independence, mobility, well-being, and COPD symptoms, has undergone formative and summative evaluation for adults with COPD.
METHODS
The primary study aim is to assess the refined EPIC intervention's feasibility and acceptability via a pilot hybrid effectiveness-implementation randomized control trial in community-dwelling older adults with moderate to severe COPD and their family caregivers. The secondary aim is to explore the impact of EPIC on patient and caregiver outcomes. Older adults with COPD and their family caregivers (target N = 60 dyads) will be randomized to EPIC (intervention) or usual COPD care (control). EPIC includes six patient and four family caregiver weekly, telephone-based nurse coach sessions using a manualized curriculum (Charting Your Course), plus three monthly follow-up calls. Feasibility will be measured as completion of EPIC intervention and trial components (e.g., recruitment, retention, data collection). Acceptability will be evaluated using satisfaction surveys and post-study feedback interviews. A blinded data collector will assess exploratory outcomes (e.g., Life-Space mobility, quality of life, caregiver burden, emotional symptoms, loneliness, cognitive impairment, functional status, healthcare utilization) at baseline, 12, and 24 weeks.
DISCUSSION
This intervention fills a gap in addressing the geriatrics and palliative care needs and equity for adults with COPD and their family caregivers.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05040386.
背景
EPIC（使慢性阻塞性肺疾病患者独立）是一项基于 Baltes 成功老龄化理论并改编自 ENABLE（教育、培育、建议、生命结束前）干预的老年病学-姑息治疗电话、护士教练干预措施，专门用于改善独立性、流动性、幸福感和慢性阻塞性肺病症状。EPIC 已经对慢性阻塞性肺病患者进行了形成性和总结性评估。
方法
主要研究目的是通过一项针对社区居住的中重度慢性阻塞性肺病患者及其家庭照顾者的试点混合有效性-实施随机对照试验，评估经过改进的 EPIC 干预措施的可行性和可接受性。次要目的是探讨 EPIC 对患者和照顾者结果的影响。患有慢性阻塞性肺病的老年人及其家庭照顾者（目标 N=60 对）将被随机分配到 EPIC（干预）或常规慢性阻塞性肺病护理（对照）。EPIC 包括六次患者和四次家庭照顾者每周一次的电话护士教练课程，使用标准化课程（规划你的课程），外加三次每月随访电话。可行性将通过 EPIC 干预和试验组件的完成情况来衡量（例如，招募、保留、数据收集）。可接受性将通过满意度调查和研究后反馈访谈进行评估。一个盲目的数据收集器将在基线、12 周和 24 周评估探索性结果（例如，生活空间流动性、生活质量、照顾者负担、情绪症状、孤独感、认知障碍、功能状态、医疗保健利用）。
讨论
这项干预措施填补了满足慢性阻塞性肺病患者及其家庭照顾者的老年病学和姑息治疗需求和公平性的空白。
试验注册
ClinicalTrials.gov 标识符：NCT05040386。
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