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印第安纳州阿尔茨海默病姑息治疗卓越努力(IN-PEACE):在晚期痴呆患者中进行随机对照试验的方案。

Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia.

机构信息

Indiana University Center for Aging Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.

Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, USA; Center for Health Services Research, Regenstrief Institute, Inc, Indianapolis, IN, USA.

出版信息

Contemp Clin Trials. 2023 Jul;130:107217. doi: 10.1016/j.cct.2023.107217. Epub 2023 May 4.

DOI:10.1016/j.cct.2023.107217
PMID:37149000
Abstract

BACKGROUND

Dementia affects 6.5 million persons in the U.S., a number which is expected to double by 2060. More than half of persons with dementia die at home, creating an enormous burden for both patients and caregivers. However, there is a paucity of research on community-based palliative care interventions for advanced dementia.

OBJECTIVES

The Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE) study is a randomized trial to test the effectiveness of a collaborative predominantly telehealth home-based intervention for persons with advanced dementia residing in the community and their primary, informal caregivers. The primary aim is to determine if this palliative care focused supportive intervention is superior to usual care in reducing neuropsychiatric symptoms of dementia. Secondarily, intervention effects on other patient symptoms (e.g., pain), caregiver distress and depression, and emergency department (ED)/hospitalization events are examined.

METHODS

The study population consists of participant pairs comprising a person with dementia and their primary, informal caregiver. The person with dementia must be ≥65 years old, with a clinical diagnosis of moderate to severe dementia. A total of 201 demographically and socioeconomically diverse participant pairs have been randomized to the IN-PEACE care coordination intervention (n = 99) or usual care (n = 102). Outcome assessments are conducted at baseline, and quarterly for up to 2 years (3, 6, 9, 12, 15, 18, 21, and 24 months).

DISCUSSION

IN-PEACE results will inform care for the large number of individuals with advanced dementia residing in the community and enable informal caregivers to provide effective home-based care.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT03773757.

摘要

背景

痴呆影响了美国 650 万人,预计到 2060 年这一数字将翻一番。超过一半的痴呆症患者在家中死亡,给患者和护理人员带来了巨大的负担。然而,针对晚期痴呆症的基于社区的姑息治疗干预措施的研究却很少。

目的

印第安纳州阿尔茨海默病姑息治疗卓越努力(IN-PEACE)研究是一项随机试验,旨在测试针对居住在社区中的晚期痴呆症患者及其主要非专业护理人员的协作型主要基于远程医疗的家庭干预措施的有效性。主要目的是确定这种以姑息治疗为重点的支持性干预措施是否优于常规护理,以减轻痴呆症的神经精神症状。其次,还研究了干预措施对其他患者症状(例如疼痛)、护理人员的痛苦和抑郁以及急诊部(ED)/住院事件的影响。

方法

研究人群由患者和主要非专业护理人员组成的一对参与者组成。患者必须≥65 岁,有中度至重度痴呆的临床诊断。共有 201 名在人口统计学和社会经济学方面具有多样性的参与者对 IN-PEACE 护理协调干预(n=99)或常规护理(n=102)进行了随机分组。在基线时以及最多 2 年内每季度进行一次(3、6、9、12、15、18、21 和 24 个月)进行评估。

讨论

IN-PEACE 的结果将为居住在社区中的大量晚期痴呆症患者提供护理,并使非专业护理人员能够提供有效的家庭护理。

试验注册

clinicaltrials.gov 标识符:NCT03773757。

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Contemp Clin Trials. 2023 Jul;130:107217. doi: 10.1016/j.cct.2023.107217. Epub 2023 May 4.
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引用本文的文献

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Palliative Care Program for Community-Dwelling Individuals With Dementia and Caregivers: The IN-PEACE Randomized Clinical Trial.针对社区痴呆患者及其照料者的姑息治疗项目:IN-PEACE随机临床试验
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