A Pilot Study To Assess The Dynamic Difficulty Adjustment In Personalized Testing For Persons With MCI And Matched Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Number of test iterations until stable difficulty level is reached
研究概览
简要总结
The goal of this observational study is to evaluate the functionality and usability of Indivi mobile application-based cognitive activities in people with mild cognitive impairment/mild Alzheimer's disease (PwMCI/AD) and healthy controls (HC). This application uses a dynamic difficulty adjustment (DDA) system that customizes the level of the cognitive activities to each user.
The main questions it aims to answer are:
- Does the DDA system reach a stable difficulty level at the same rate for both PwMCI/AD and HC?
- Is the stable difficulty level reached by the DDA system different for PwMCI/AD compared to HC?
Researchers will also compare cognitive activities results and other aspects of the mobile application's performance to see if the application can validly distinguish between the two groups.
Participants will use the Indivi mobile application, with its embedded DDA system, for a 6-week period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is part of BU-ADRC cohort.
- •Participant is diagnosed with MCI, mild AD, or is classified as HC per BU-ADRC, with available required data for inclusion obtained less than 2 years before the inclusion.
- •Participant is between 50 and 90 years old, included.
- •Participant is able to use a smartphone.
- •Participant has sufficient knowledge of the English language.
- •Participant is able to and has an intention to follow the study procedures.
- •Informed Consent as documented by signature.
排除标准
- •Participant has any neurological condition that may be contributing to cognitive impairment (above and beyond that caused by the subject's MCI or AD).
- •Participant has psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures.
- •Participant has a history of stroke or seizures within the last 24 months.
- •Participant has a Geriatric Depression Scale (GDS) score ≥
- •Participant has a severe visual or hearing impairment that would interfere with capacity to perform cognitive assessments.
- •Known or suspected non-compliance.
研究组 & 干预措施
PwMCI/AD
Persons with Mild Cognitive Impairment or mild Alzheimer's Disease
HC
Healthy Controls
结局指标
主要结局
Number of test iterations until stable difficulty level is reached
时间窗: During the 6-week study period.
Stable difficulty level is defined as no increase in difficulty across 3 consecutive test iterations. Comparison will be made between PwMCI and HC.
Distribution of participants across assessment levels at steady-state difficulty
时间窗: During the 6-week study period
Steady-state difficulty is defined as no increase in difficulty across 3 consecutive test iterations. The outcome will describe the distribution pattern of participants across the available assessment levels at steady-state.
次要结局
未报告次要终点