Efficacy of a Technology-Based Multimodal Brain Health Intervention for Older African Americans: The SHARP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Daily Average Steps Recorded by Actigraphy Watch
研究概览
简要总结
This study tests the feasibility, acceptability, and efficacy of a multimodal intervention (walking, social engagement, and reminiscence), including the use of wearable digital biomarkers, for cognitively healthy and mildly cognitively impaired African Americans aged 65 and older.
详细描述
Cognitively healthy and mildly cognitively impaired participants engage in up to 8 weeks of baseline data collection and 4-16 weeks of triadic neighborhood walking using a group tablet device to access pre-programmed 1-mile routes. GPS (Global Positioning System)-triggered historical images of local Black culture and history along the route prompt conversational reminiscence about Portland, Oregon's historically Black neighborhoods. Digital biomarker technology (a continuously worn actigraph watch and an unobtrusive under-the-mattress sleep sensor) and weekly online surveys via a study Chromebook assess feasibility, acceptability, efficacy, and health outcomes. Intermittent discussions and check-ins with participants, and observational sessions will be used to elicit participant feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Self-reported or clinically diagnosed dementia
- •Significant disease of the central nervous system
- •Severely depressed (CES-D score > 16), significantly symptomatic psychiatric disorder
- •Advanced cardiovascular disease that would make walking difficult, including history of congestive heart failure
- •Unstable insulin-dependent diabetes mellitus, received diagnosis Type 1 Diabetes, started insulin within past 3 months, hospitalized for hypoglycemia within past 6 months.
结局指标
主要结局
Daily Average Steps Recorded by Actigraphy Watch
时间窗: 24 weeks
Daily steps are recorded on a continuously worn actigraphy watch (Withings), which measures 24-hour activity (gross motor activity).
Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor
时间窗: 24 weeks
Emfit QS under-the-mattress sleep sensor measured sleep-wake cycles per 24-hour period.
Weekly Health Update Survey Response Time
时间窗: 24 weeks
Participants completed a brief health update survey every week via their home computer or phone. Response time (the time it took each participant to complete the survey) was recorded in seconds.
Pittsburgh Sleep Quality Index
时间窗: 24 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire assessing sleep quality and sleep disturbances over a 1-month time period. The PQSI is composed of 19 query items, a combination of open-ended questions and Likert-type scales which are scored from 0 (no difficulty) to 3 (severe difficulty), and includes 7 sleep components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global score is calculated from the sum of scores for each of the seven components. Total scores range from 0 to 21, a higher score indicates more acute sleep disturbances.
Weekly Survey Completion Rate
时间窗: 24 Weeks
Healthy and mildly cognitively impaired participants completed a weekly online health update survey, receiving weekly reminders to complete it. Survey completion rates and completion times over the study's duration is another measure of cognitive change.
次要结局
未报告次要终点
研究者
Raina Croff
Co-Investigator
Oregon Health and Science University