跳至主要内容
临床试验/NCT02971124
NCT02971124进行中(未招募)不适用

Observational Study to Assess Cognitive Performance in Elderly Life Via Meaning Play

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家实际入组 30 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Specification of Cognitive Performance Metrics for the game Solitaire

研究概览

简要总结

To assess cognitive performance by means of the game of Solitaire. In this study, the investigators want to define relevant game metrics, when playing Solitaire, that may be indicative of cognitive performance.

详细描述

12-15 healthy older persons will be observed, as well as 12-15 persons with cognitive impairment, while playing Solitaire. This will take the shape of contextual inquiries, i.e. the researcher visits the older person in his/her natural context and ask his/her to play Solitaire. Older persons will be observed playing 8-10 rounds of playing Solitaire, both with a physical deck of card and on a tablet. Gameplay actions and player behaviors will be observed and recorded for later analysis, via screen capturing software installed on the tablet, including the recordings of facial expressions and verbal utterances via the integrated touchpad camera and microphone. According to the contextual inquiry method, which is a 'light' form of participant observation, the researcher will take the role of an 'apprentice'; he/she will observe and may ask questions for a better understanding of the player actions. At the end of the visit, following cognitive domains will be measured through pen-and-paper testing: visual scanning and psychomotor speed (Digit symbol substitution test), attention and executive function (Trail making test, digit span, verbal fluency, maze test), Camden topographical memory,... The duration of such a visit will last approximately 120 minutes.

These observations of game play actions and behaviors and the results that participants obtained on the cognitive test battery will be analyzed with experts in light of cognitive performance. More particular, the investigator will look for the measurable aspects of cognitive performance in the game, guided by earlier measures put forward by Jimison et al and Kaye et al. While they still list generic measures (e.g. 'target detection' or 'correctly retrieving item from previous knowledge'), this study will now operationalize these specifically for the game of Solitaire and for the target group (e.g. 'detection of card to move onto the build stack' or 'retrieving the card as available from the pile'). Hence, possible game metrics will be discussed and defined.

研究设计

研究类型
观察性
观察模型
病例对照
时间视角
前瞻性

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • For the HEALTHY participants
  • The participant has a minimum age of 65 years.
  • The participant is living independently or semi-independently at home, service flat or care home.
  • The participant has no subjective memory concern as reported by the participant, informant, or clinician.
  • The participant has a normal brain function documented by scoring above 27 on the MMSE, above 26 on the MOCA and has a score of 0 for the CDR.
  • In the opinion of the investigator, the participant is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator.
  • The participant is fluent in written and verbal Dutch.
  • For the participants with COGNITIVE IMPAIRMENT:
  • The participant has a minimum age of 65 years.
  • The participant is living independently or semi-independently at home, service flat or care home.
  • In the opinion of the investigator, the participant is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator.
  • The participant is fluent in written and verbal Dutch.
  • For MCI: MCI patients, at baseline, are diagnosed applying Petersen's diagnostic criteria, i.e., (1) cognitive complaint, preferably corroborated by an informant; (2) objective cognitive impairment, quantified as performance of more than 1.5 SD below the appropriate mean on the neuropsychological subtests (z-score below -1.5); (3) largely normal general cognitive functioning; (4) essentially intact activities of daily living (ADL) (basic and instrumental activities of daily living (iADL) were determined by a clinical interview with the patient and an informant); and (5) not demented.
  • For AD:Probable AD according to the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines

排除标准

  • 未提供

结局指标

主要结局

Specification of Cognitive Performance Metrics for the game Solitaire

时间窗: 1 day

From this study, metrics will be defined which can measure cognitive performance in cardgames like Solitaire. Possible candidates are, but are not limited to: situational awareness to measure visual perception and performance on dual tasks to measure divided attention. A more detailed table of possible game metrics of cognitive performance can be found in H. B. Jimison, M. Pavel, P. Bissell, and J. McKanna, "A Framework for Cognitive Monitoring Using Computer Game Interactions," Medinfo 2007 Proc. 12th World Congr. Health Med. Inform. Build. Sustain. Health Syst., p. 1073, 2007.

次要结局

  • Design Guidelines Apps for the Elderly(1 day)

研究者

申办方类型
其他
责任方
申办方

研究点 (2)

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标识符

NCT 编号
NCT02971124
其他研究编号
S59650

日期

首次提交
(9年前)
首次发布
(9年前)
主要完成日期
(4年前)
研究完成日期
(去年)
最近核实
最近更新
(2年前)

监管与共享

FDA 监管药物
否
个体参与者数据共享计划
UNDECIDED
是否有结果
否

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