Katz Amy J, Chang Pei-Shiu, Gao Sujuan, Apostolova Liana G, Passey Richard T, Yang Ziyi, Ceniza Dane, Lu Yvonne
Indiana University School of Nursing, Department of Science of Nursing Care, 600 Barnhill Drive, Indianapolis, IN 46202, USA.
Indiana University School of Nursing, Bloomington Campus, Department of Community & Health Systems, 2631 E Discovery Parkway, Bloomington, IN 47408, USA.
Contemp Clin Trials. 2025 Apr;151:107836. doi: 10.1016/j.cct.2025.107836. Epub 2025 Feb 8.
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.
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.
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).
The DEMA results will inform care for the broader PwCI and CG population in community and home-based settings.
近三分之一的美国老年人存在认知障碍（轻度认知障碍或主观认知衰退）。认知障碍对老年人、照料者以及社会有着非同寻常的影响。认知障碍患者及其主要照料者的生活满意度不断下降是一个普遍存在的问题。然而，关于基于优势的积极健康方法以及对认知障碍患者及其照料者的支持性护理的研究却很匮乏。
促进有意义活动再参与（PRIMA）研究是一项随机对照试验，旨在测试有意义活动每日参与（DEMA）干预对认知障碍患者及其照料者的疗效。主要目的是测试随着时间推移，DEMA在提高认知障碍患者及其照料者生活满意度方面的疗效。第二个目的是评估该干预如何随着时间推移改善活动表现、减轻认知障碍患者及其照料者的抑郁症状和焦虑，并减轻照料者负担。第三个目的是探索该治疗方法在有（或无）抑郁症状（基线时患者健康问卷（PHQ）-9≥5）的认知障碍患者亚样本中随着时间推移改善健康结局的疗效。
研究人群由认知障碍患者及其照料者组成的二元组构成。认知障碍患者必须年满60岁且患有认知障碍。总共200个认知障碍患者-照料者二元组将被随机分配到DEMA组或注意力控制组。结局评估在9个月内进行（基线、干预后10天、3个月和6个月）。
DEMA的结果将为社区和家庭环境中更广泛的认知障碍患者及其照料者群体的护理提供信息。
