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临床试验/NCT05040386
NCT05040386已完成不适用

Nurse Coach-Led Early Palliative Care for Older Adults With Chronic Obstructive Pulmonary Disease and Their Care Partners: The Project EPIC Pilot Randomized Controlled Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Intervention Feasibility

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in older Americans. COPD increases in frequency with age, and older adults with COPD often have significant unmet geriatrics-palliative care needs that results in reduced quality of life, high healthcare utilization, and care at the end of life that does not align with the values and wishes of patients and their care partners. Older adults with COPD could benefit from proactive geriatrics-palliative care before the end of life. However, no geriatrics-palliative care interventions have been systematically developed and tested in community-dwelling older adults with COPD and their care partners. As the number of older adults with COPD increases to levels unmatched by current palliative care workforce trends, innovative strategies are desperately needed to improve the delivery of geriatrics-palliative care in COPD before the end of life.

Project EPIC (Empowering People to Independence in COPD) is a multiphase study to refine and pilot test the EPIC telephonic nurse coaching intervention in older adults with COPD and their care partners. EPIC is informed by the ENABLE (Educate, Nurture, Advise Before Life Ends) early palliative care intervention that improved quality of life and mood for patients with advanced cancer and has been iteratively refined over decades and rigorous randomized controlled trial testing. In the intervention, palliative care-trained nurse coaches deliver the Charting Your Course Curriculum over the phone to patients (six sessions) and their care partners (four sessions), with activities and monthly telephone follow-up following a manualized curriculum. We conducted a formative evaluation in a diverse and multidisciplinary group of stakeholders to refine ENABLE for patients with COPD and pilot tested the potential feasibility of the refined intervention, EPIC, in patients and their care partners.

The current study summatively evaluates EPIC through a hybrid effectiveness-implementation pilot randomized controlled trial in dyads of community-dwelling older adults with moderate to very severe COPD and their care partners randomized to usual care (control) versus EPIC (intervention). The primary outcomes are intervention feasibility and acceptability. Secondary outcomes include Life-Space mobility, quality of life, cognitive impairment, functional status, palliative care uptake, and care partner burden.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Usual Care

Active Comparator

Patient participants randomized to this arm will receive the standard of care for COPD. Caregiver participants, if available, will be randomized to the same study arm as the patient participant.

干预措施: Usual Care (Other)

Intervention (EPIC)

Experimental

Participants randomized to this arm will receive the experimental treatment for COPD (i.e. EPIC). Caregiver participants, if available, will be randomized to the same study arm as the patient participant.

干预措施: EPIC (Empower People to Independence in COPD) (Behavioral)

结局指标

主要结局

Intervention Feasibility

时间窗: 6 months

In participants randomized to the intervention arm, we will measure the mean (SD) number of core EPIC patient and caregiver telephonic nurse coaching sessions out of a possible 10 and 8 sessions completed, respectively.

Survey Feasibility

时间窗: 6 months

Survey completion rates will be measured and presented as the count of patient and caregiver participants who completed 100% of all available survey sets across the study.

Intervention Acceptability Score

时间窗: 6 months

Mean (SD) score on a scale of 1 being very poor and 10 being excellent for the EPIC intervention as rated by patient and caregiver participants randomized to the intervention group.

Count of Acceptability Qualitative Interviews

时间窗: 6 months

Count of patient and caregiver participants completing the follow-up semi-structured, in-depth interviews.

次要结局

  • UAB Life Space Assessment(6 months)
  • Chronic Respiratory Questionnaire (CRQ)(6 months)
  • PROMIS Global Health 10(6 months)
  • Montgomery Borgatta Caregiver Burden(6 months)
  • Hospital Anxiety and Depression Scale (HADS)(6 months)
  • Modified Telephone Interview for Cognitive Status (mTICS)(6 months)
  • Katz Index of Activities of Daily Living(6 months)
  • Lawton Instrumental Activities of Daily Living(6 months)
  • Advance Directive Completion(6 months)
  • De Jon Gierveld Loneliness Scale(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anand Iyer

Associate Professor

University of Alabama at Birmingham

研究点 (2)

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