Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- concordance index
研究概览
简要总结
The present project is an evolution of the previous RIN 2019 study aimed at validating and standardizing the Uniform Data Set (UDS) for dementia, a battery of tests exploring various cognitive domains (memory, language, praxis, executive functions) and involving partial tablet-based computerization for data collection.
In the present study, a UDS-based instrument that can be used in remote examiner-assisted telematic administration will be validated. This will be followed by standardization of the same on a sample of healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •female and male subject between 50 and 90 years
- •no negative score on the Anamnestic Questionnaire
- •internist pathology in pharmacological compensation
- •signing of informed consent
排除标准
- •neurological pathologies
- •decompensated metabolic pathology
- •use of Benzodiazepine and psychoactive drugs
研究组 & 干预措施
Normal subjects
干预措施: IUDS (Diagnostic Test)
结局指标
主要结局
concordance index
时间窗: from baseline through study completion, an average of 1 year and a half
Measure the concordance index in the administration of individual battery tests between in-person and computer-based administration
次要结局
- regression lines(from baseline through study completion, an average of 1 year and a half)