移动远程医疗干预以支持阿尔茨海默病及相关痴呆症患者的护理伙伴（I-CARE 2）：一项随机有效性临床试验方案

Mobile Telehealth Intervention to Support Care Partners of Patients With Alzheimer Disease and Related Dementias (I-CARE 2): Protocol for a Randomized Effectiveness Clinical Trial.

作者信息

Hill Jordan R, Gardner Bailey, Rodriguez Miriam J, Golzarri-Arroyo Lilian, Zoh Roger S, Boustani Zayn, Burnell Jacqueline, Jordan Evan J, Boustani Malaz A, Holden Richard J

机构信息

Department of Health & Wellness Design, School of Public Health - Bloomington, Indiana University, Bloomington, United States.

Department of Epidemiology and Biostatistics, School of Public Health - Bloomington, Indiana University, Bloomington, United States.

出版信息

JMIR Res Protoc. 2025 Sep 3;14:e73387. doi: 10.2196/73387.

DOI:10.2196/73387

PMID:40902155

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12444222/

Abstract

BACKGROUND

Nearly all individuals with Alzheimer disease and related dementias (ADRD) experience behavioral and psychological symptoms of dementia (BPSD), which include symptoms such as agitation, wandering, delusions, and hallucinations. Care partners (a person, often a family member, who provides care and support to someone with ADRD) struggle to manage BPSD, making symptom management a critical focus of intervention research. Our team has developed a mobile telehealth intervention (Brain CareNotes) to help care partners manage BPSD.

OBJECTIVE

This paper outlines a protocol for a randomized controlled trial of 160 care partners of patients with ADRD to test the effect of Brain CareNotes on care partner burden and patients' BPSD.

METHODS

Participants will be recruited from partner health systems in Indiana, United States, by word of mouth, and through community outreach efforts. They will be randomly assigned to use either the Brain CareNotes mobile app intervention-which helps care partners manage BPSD through the support of a care coach, written and visual materials on developing care skills, and BPSD measurement and tracking-or an education-only mobile app control for 12 months. Data will be collected over the phone at baseline, 6 months, and 12 months. Primary outcomes assessed for this trial are (1) care partner burden and (2) patients' BPSD. Secondary and exploratory outcomes assessed include care partner depressive symptoms, patient and care partner acute care use, intervention usability and acceptability, and intervention use. The trial will also collect patient and care partner demographics and measure care partner self-efficacy, care partner social support, patients' ADRD severity, and patients' functional abilities.

RESULTS

As of March 2025, we have enrolled 159 participants, and 42 have successfully completed the study.

CONCLUSIONS

Brain CareNotes is a unique mobile app intervention to support care partners in managing BPSD. Due to the scalability of mobile health interventions, if Brain CareNotes is shown to be effective in reducing caregiver burden and patients' BPSD, it has the potential for widespread adoption to support many ADRD care partners.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/73387.

摘要

背景

几乎所有患有阿尔茨海默病及相关痴呆症（ADRD）的个体都会经历痴呆的行为和心理症状（BPSD），这些症状包括激动、徘徊、妄想和幻觉等。护理伙伴（通常是家庭成员，为患有ADRD的人提供护理和支持）在管理BPSD方面面临困难，因此症状管理成为干预研究的关键重点。我们的团队开发了一种移动远程医疗干预措施（Brain CareNotes），以帮助护理伙伴管理BPSD。

目的

本文概述了一项针对160名ADRD患者护理伙伴的随机对照试验方案，以测试Brain CareNotes对护理伙伴负担和患者BPSD的影响。

方法

参与者将通过口碑宣传以及社区推广活动，从美国印第安纳州的合作医疗系统中招募。他们将被随机分配使用Brain CareNotes移动应用程序干预措施（通过护理指导的支持、关于护理技能培养的书面和视觉材料以及BPSD测量与跟踪，帮助护理伙伴管理BPSD）或仅用于教育的移动应用程序对照组，为期12个月。在基线、6个月和12个月时通过电话收集数据。本试验评估的主要结局为：（1）护理伙伴负担；（2）患者的BPSD。评估的次要和探索性结局包括护理伙伴的抑郁症状、患者和护理伙伴的急性护理使用情况、干预的可用性和可接受性以及干预的使用情况。该试验还将收集患者和护理伙伴的人口统计学信息，并测量护理伙伴的自我效能感、护理伙伴的社会支持、患者的ADRD严重程度以及患者的功能能力。