促进认知障碍患者及其护理人员参与有意义的日常活动：随机临床试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-08 DOI:10.1016/j.cct.2025.107836

Amy J. Katz , Pei-Shiu Chang , Sujuan Gao , Liana G. Apostolova , Richard T. Passey , Ziyi Yang , Dane Ceniza , Yvonne Lu

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引用次数: 0

摘要

背景：近三分之一的美国老年人有认知障碍（轻度认知障碍或主观认知能力下降）。认知障碍（CI）对老年人、护理人员（CG）和社会产生了巨大的影响。CI患者及其原发CG的生活满意度恶化是一个普遍存在的问题。然而，关于基于力量的积极健康方法和对PwCI及其CG的支持性护理的研究缺乏。目的：促进有意义活动的再参与（PRIMA）研究是一项随机对照试验，旨在测试日常有意义活动参与（DEMA）干预对PwCI及其cg的疗效。主要目的是测试DEMA在改善PwCI及其CGs生活满意度方面的功效。第二个目的是评估干预如何改善PwCI和CG的活动表现，减少抑郁症状和焦虑，并随着时间的推移减轻CG负担。第三个目的是探索治疗在有（和没有）抑郁症状的pwci亚样本中的疗效（患者健康问卷(PHQ)-9 ≥ 5基线），以改善健康结果。方法：研究人群由二联体、一个PwCI及其CG组成。PwCI必须是60岁 岁，并有CI。共有200名PwCI-CG组将被随机分配到DEMA组或注意对照组。结果评估在9个月内进行（基线，干预后10 天，3个月和6个月）。讨论：DEMA结果将为社区和家庭环境中更广泛的PwCI和CG人群的护理提供信息。

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Promoting daily engagement in meaningful activity (DEMA) for people with cognitive impairment and their caregivers: Protocol for a randomized clinical trial

Background

Nearly one-third of older American adults have cognitive impairment (mild cognitive impairment or subjective cognitive decline). Cognitive impairment (CI) has an extraordinary impact on older adults, caregivers (CG), and society. Deteriorating life satisfaction in persons with CI (PwCI) and their primary CG is a prevalent problem. However, there is a paucity of research on a strength-based, positive health approach, and supportive care for PwCI and their CG.

Objectives

The promoting re-engagement in meaningful activity (PRIMA) study is a randomized controlled trial to test the efficacy of the Daily Engagement in Meaningful Activity (DEMA) intervention for PwCI and their CGs. The primary aim is to test DEMA's efficacy for improving life satisfaction in PwCI and their CGs over time. The second aim evaluates how the intervention improves activity performance, decreases depressive symptoms and anxiety in PwCI and CGs, and reduces CG burden over time. The third aim is to explore the treatment's efficacy among a sub-sample of PwCIs with (and without) depressive symptoms (Patient Health Questionnaire (PHQ)-9 ≥ 5 at baseline) for improvement in health outcomes over time.

Methods

The study population consists of dyads, a PwCI and their CG. The PwCI must be 60 years old and have CI. A total of 200 PwCI-CG dyads will be randomized to the DEMA or attention control group. Outcome assessments are conducted over 9-months (baseline, 10 days-, 3- and 6- months post-intervention).

Discussion

The DEMA results will inform care for the broader PwCI and CG population in community and home-based settings.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.