mHealth Cognitive Training Intervention Pilot for Older Chinese Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Feasibility as Measured by the status of study accrual
研究概览
简要总结
The purpose of this study is to develop and pilot test a mHealth intervention for cognitive training that is culturally and linguistically relevant to older Chinese Americans
详细描述
This is an NIH Stage 1 pilot randomized controlled trial. The purpose of this trial is to evaluate the feasibility, acceptability, and obtain preliminary effect sizes on outcomes of a cognitive training intervention. The cognitive training intervention will be app-based and will be co-developed with older Chinese Americans and adult children to ensure it is culturally and linguistically relevant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identify as Chinese
- •are age 60 or older
- •are fluent in written and spoken Chinese and/or English
- •have the visual capacity to read a smartphone or a tablet screen and have the auditory capacity to understand normal speech
- •have no self-reported diagnosis of ADRD or cognitive impairment, and are capable of making an informed consent
排除标准
- •Individuals are excluded if they are bed-ridden
- •receiving chemotherapy for malignancy
- •have other life-threatening illnesses
结局指标
主要结局
Feasibility as Measured by the status of study accrual
时间窗: Approximately 6 months
Meeting the recruitment goal of 30 eligible participants in 6 months (Yes/No)
Feasibility as Measured by Adherence to Measurement Strategies at week 12
时间窗: 12 weeks
The proportion of participants completing the 12-week assessments in both arms
Change in Global cognition as a composite measure of Mini-Mental State Examination(MMSE), Digit Span Test, verbal fluency, and the Trail Making Test
时间窗: Baseline, 8 weeks, 12 weeks
A z-score of each test will be calculated and the average z-score that ranges from -1 to 1 will be used to measure global cognition, with higher score indicated better cognitive function
Feasibility as Measured by Study Adherence
时间窗: 12 weeks
The proportion of participants in the intervention arm who successfully completing all intervention sessions
Feasibility as Measured by Adherence to Measurement Strategies at week 8
时间窗: 8 weeks
The proportion of participants completing the 8-week assessments in both arms
Days of App use as Measured by the percentage of days that participants use the app
时间窗: Over the course of the intervention, 12 weeks
The percentage of days that participants use the app for participants in the intervention arm over the course of study participation, with higher proportion indicated more days engaged in cognitive training
Acceptability as Measured by the Client Satisfaction Questionnaire
时间窗: 12 weeks
The Client Satisfaction Questionnaire (CSQ) ranges from 8 to 32, with scores over the 80% suggested adequate acceptability
Duration of cognitive training as Measured by the average time to complete a cognitive exercise
时间窗: Over the course of the intervention, 12 weeks
The average time in minutes to complete a cognitive exercise for participants in the intervention arm over the course of study participation, with longer duration indicated longer training
次要结局
- Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale-Anxiety Subscale(Baseline, 8 weeks, 12 weeks)
- Change in Loneliness as Measured by the University of California, Los Angeles three item Loneliness Scale(Baseline, 8 weeks, 12 weeks)
- Change in Physical Functioning as Measured by the Activities of Daily Living and Instrumental Activities of Daily Living Scale(Baseline, 8 weeks, 12 weeks)
- Change in Depressive Symptoms as Measured by the Patient Health Questionnaire-9(Baseline, 8 weeks, 12 weeks)
- Change in Quality of Life as Measured by the World Health Organization Quality of Life Instrument- Abbreviated Version (WHOQOL-BREF)(Baseline, 8 weeks, 12 weeks)