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临床试验/NCT07521865
NCT07521865已完成不适用

Remote Technologies in Early Stages of Alzheimer's Disease: Feasibility, Usability, and Acceptance of an App-based Cognitive Training

University of Bern1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Feasibility of tablet-based cognitive training

研究概览

简要总结

The investigators are adapting a tablet-based cognitive training program for Alzheimer's disease (AD) by focusing on specific cognitive components. It is aimed to demonstrate the feasibility, acceptability and usability of remote cognitive training in older adults with Mild Cognitive Impairment (MCI) and AD dementia. The study involves 36 participants in three groups, with a two-week intervention and focus groups for refinement.

详细描述

The investigators aim to extend a tablet-computer-based cognitive training (CT), fully developed in house (KEK 2020-00630), and tailored specifically towards a "typical-AD" cognitive component. This cognitive component is defined through a principal-component analysis (PCA), on which the domains affected by AD (episodic memory, spatial processing, semantic memory) have high loadings. The investigators moreover train working memory training to facilitate transfer effects. By including carers (family members, friends, professional carers) in the focus groups and the integration of help buttons, the investigators expect high adherence. The CT will be based on our ongoing study assessing the CT in people at risk for AD and subjective cognitive decline.

The investigators plan a small feasibility study in three different groups with a total of 36 elderly participants including cognitively normal (N=12), MCI (N=12), and mild-moderate stage dementia due to AD (N=12).

The focus will be on qualitative content analyses based on the results from the focus groups. The results from the first focus group sessions serve the selection, adaptation, and improvement of the CT before it is implemented in the two-week intervention including daily 30-minutes training sessions. A second focus group after the intervention will serve to gain additional insights from users and carers to further improve the CT. To complement this information, the investigators will quantitatively compare specific game parameters related to feasibility (number of levels achieved, numbers of sessions finished, number of dropouts), usability (time until reaching level 1 - learn duration, numbers of help button presses), and acceptability (game evaluation) between the three treatment groups.

The investigators aim to demonstrate that remote CT is possible in older adults with Mild Cognitive Impairment (MCI) and diagnosed AD dementia at home and in the care home setting by extending an existing tablet-based CT app with additional (easier) training levels, additional and detailed introductory material to also allow cognitively more severely impaired participants to conduct the CT with as little external support as possible. This study is considered as Risk Category A. The study intervention consists of a tablet-based CT, which does not provide any known risks for the participants.

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
70 Years 至 95 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants and study partners fulfilling all the following inclusion criteria are eligible for the study:
  • Informed Consent as documented by signature
  • Study partners:
  • Native or fluent German speaker
  • Participants:
  • Are able to give their consent to participate in the study
  • Age between 70 and 95 years
  • Native or fluent German speaker
  • Normal or corrected to normal vision and hearing
  • Ability to visit the study location repeatedly
  • MoCA score > 11

排除标准

  • Substance abuse
  • Severe neurological or psychiatric conditions (of note: patients with mild depressive symptoms not fulfilling the criteria for major depressive disorder will be recruited into the sample to better represent clinical reality)

研究组 & 干预措施

HC - Healthy Control Group

Healthy, age- and sex-matched participants (cognitively normal)

干预措施: App-based cognitive training (Device)

MCI - Mild Cognitive Impairment

Participants with MCI

干预措施: App-based cognitive training (Device)

AD - Alzheimer's Disease

Participants with mild-moderate stage dementia due to AD

干预措施: App-based cognitive training (Device)

结局指标

主要结局

Feasibility of tablet-based cognitive training

时间窗: Assessed at the end of the 2-week intervention (Day 10)

Compliance rate (i.e.number of sessions completed)

次要结局

  • Feasibility of tablet-based cognitive training(Assessed at the end of the 2-week intervention (Day 10))
  • Usability(Assessed at the end of the 2-week intervention (Day 10))
  • Acceptability(Assessed within two weeks after day 10 of the intervention)
  • 2. Feasibility of tablet-based cognitive training(Assessed at the end of the 2-week intervention (Day 10))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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