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针对美国华裔老年人的联合设计的基于手机的认知训练:一项评估可行性和可接受性的试点随机对照试验方案

Co-Designed Mobile-Based Cognitive Training for Older Chinese Americans: Protocol for a Pilot Randomized Controlled Trial Assessing Feasibility and Acceptability.

作者信息

Xue Tingzhong, Wei Aybey Amy, Wu Bei, Sanders Camilla, McConnell Eleanor Schildwachter, Xu Hanzhang

机构信息

Elaine Marieb College of Nursing, University of Massachusetts Amherst, Amherst, MA, United States.

School of Nursing, Duke University, Durham, NC, United States.

出版信息

JMIR Res Protoc. 2025 Jul 21;14:e69303. doi: 10.2196/69303.

Abstract

BACKGROUND

Older Chinese Americans are at high risk of dementia, yet they often do not access culturally relevant services/programs to reduce their risks due to issues such as language barriers and transportation. BrainHQ is a mobile-based, effective cognitive training program that can potentially address these barriers and delay cognitive decline in older Chinese Americans.

OBJECTIVE

We aim to evaluate the feasibility and acceptability of a mobile-based cognitive training intervention co-designed by older Chinese Americans and their adult children.

METHODS

We applied an experience-based co-design approach that leverages existing cognitive training features and older Chinese Americans' prior knowledge, lived experiences, and social norms around dementia to co-develop a cognitive training intervention. We conducted an experience-based co-design workshop with Older Chinese Americans (n=10), and their adult children (n=4) to optimize the cultural and linguistic relevance of the cognitive training intervention. Participants used a journey map to brainstorm challenges they may experience when participating in the intervention. Then, the participants created prototypes of intervention components to address these challenges. Finally, we incorporated these prototypes into the co-designed intervention protocol. A total of 30 participants will be recruited into the intervention study and will be randomly assigned to the intervention or waitlist control group (2:1 ratio). The intervention group will complete the mobile-based cognitive training for between 10 and 15 minutes daily for 12 weeks. The primary outcomes are feasibility and acceptability. Global cognition, mental health, physical functioning, and quality of life will be assessed at baseline, 8, and 12 weeks.

RESULTS

This pilot trial received institutional review board approval (Pro00109934l) in November 2024. We enrolled the first participant in December 2024 and aim to complete enrollment by May 2025. We expect to complete all data collection by September 2025. We will analyze the data and report study findings by February 2026.

CONCLUSIONS

This study leverages partnerships with academic, industry, and community stakeholders and provides the groundwork for a large-scale randomized controlled trial to test the efficacy of a mobile-based cognitive training intervention for older Chinese Americans. The co-design workshop served as a feasible, innovative approach to engage with the participants and improve the study design. These findings will enhance the culturally tailored delivery of cognitive training to older Chinese Americans and provide insights for broader implementation, improving their engagement in dementia research.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05355870; https://clinicaltrials.gov/study/NCT05355870.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/69303.

摘要

背景

美国华裔老年人患痴呆症的风险很高,但由于语言障碍和交通等问题,他们往往无法获得与文化相关的服务/项目来降低风险。BrainHQ是一个基于移动设备的有效认知训练项目,有可能解决这些障碍并延缓美国华裔老年人的认知衰退。

目的

我们旨在评估由美国华裔老年人及其成年子女共同设计的基于移动设备的认知训练干预措施的可行性和可接受性。

方法

我们采用了基于经验的协同设计方法,利用现有的认知训练功能以及美国华裔老年人关于痴呆症的先验知识、生活经历和社会规范,共同开发一种认知训练干预措施。我们与10名美国华裔老年人及其4名成年子女举办了一次基于经验的协同设计研讨会,以优化认知训练干预措施在文化和语言方面的相关性。参与者使用旅程地图来头脑风暴他们在参与干预时可能遇到的挑战。然后,参与者创建干预组件的原型以应对这些挑战。最后,我们将这些原型纳入共同设计的干预方案中。总共将招募30名参与者参加干预研究,并将他们随机分配到干预组或等待名单对照组(比例为2:1)。干预组将每天完成10至15分钟的基于移动设备的认知训练,持续12周。主要结果是可行性和可接受性。将在基线、第8周和第12周评估整体认知、心理健康、身体功能和生活质量。

结果

这项试点试验于2024年11月获得机构审查委员会批准(Pro00109934l)。我们在2024年12月招募了第一名参与者,目标是在2025年5月前完成招募。我们预计在2025年9月前完成所有数据收集。我们将在2026年2月分析数据并报告研究结果。

结论

本研究利用了与学术、行业和社区利益相关者的合作关系,为一项大规模随机对照试验奠定了基础,以测试基于移动设备的认知训练干预措施对美国华裔老年人的疗效。协同设计研讨会是一种可行的创新方法,可让参与者参与进来并改进研究设计。这些发现将加强针对美国华裔老年人的文化定制认知训练,并为更广泛的实施提供见解,提高他们对痴呆症研究的参与度。

试验注册

ClinicalTrials.gov NCT05355870;https://clinicaltrials.gov/study/NCT05355870。

国际注册报告识别码(IRRID):PRR1-10.2196/69

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