The Effectiveness of TECH: Tablet Enhancement of Cognition and Health, Cognitive Training Using Touchscreen Tablet Gaming Applications, for Older Adults With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- The Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This study assess the effectiveness of novel cognitive intervention utilizing tablet apps (TECH protocol: Tablet Enhancement of Cognition and Health) to improve cognitive abilities, daily function and health-related quality of life of older adults with MCI. Older adults with MCI will be randomly allocated to the TECH protocol (experimental group) or standard care (control group). Assessments will be administered pre and post the 6-week TECH protocol and at 6-month follow-up by assessors blind to group allocation.
详细描述
A single-blind randomized controlled trial (RCT) will be conducted, by assessors blind to group allocation. Participants will be referred to the study from 'Maccabi Healthcare Services' by family physicians and geriatric physician of 'Maccabi Healthcare Services Central District'. The majority of TECH protocol training will take place in the participants' home as self-practice. The assessment and weekly group meetings will take place at clinics of Maccabi Healthcare Services in the Central District. A Helsinki approval (#2016009) has already been obtained. Participants will receive information regarding the study and if eligible will sign a consent form, undergo the screening and then the pre-intervention assessments. Then they will be randomly allocated into experimental or control group by a computer program (stratification of the severity of the cognitive decline according to the Montreal Cognitive Assessment (MoCA) scores of above or below 23 points). The experimental group participants will receive the TECH protocol, while participants in the control group will continue to receive standard care. Following the intervention a second assessment will be performed, as well as six-months follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors were blind to group allocation.
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
- •Aged 65 and above.
- •Have MCI (as determined by the following four criterions: A. a score of 19-25 on the MoCA, B. subjective memory complaints, and report from an informant of the same memory complains (the informant should be a person who interacts with the participant three or more times a week), C. Informant report of the cognitive decline as newly acquired, D. independence in Basic Activities of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL), as reported by the participants and the informant, excluding motor difficulties which are not caused due to neurological conditions or lack of performance with no changes compared to the past.
- •Have normal or corrected vision and hearing.
- •Speak, write and read Hebrew.
- •Able to understand and follow use of the touchscreen of a tablet after initial demonstration.
排除标准
- •Experience severe depressive symptoms (10 points or more in The Geriatric Depression Scale)
- •Are diagnosed with dementia, or other neurological or psychiatric condition (such as stroke, Parkinson's disease).
结局指标
主要结局
The Montreal Cognitive Assessment (MoCA)
时间窗: pre intervention, post 5 weeks intervention, follow-up after 6 months
A cognitive screening tool that assesses global cognition and includes the cognitive components: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. Total score range from 0-30. A higher score indicates a better cognitive status. A score above 26 indicates normal cognition
次要结局
- The 12-Item Short Form Health Survey (SF-12)(pre intervention, post 5 weeks intervention, follow-up after 6 months)
- WebNeuro(pre intervention, post 5 weeks intervention, follow-up after 6 months)
- General Self-Efficacy Scale(pre intervention, post 5 weeks intervention, follow-up after 6 months)
研究者
Zvi Buckman
Dr. Zvi Buckman
Assuta Hospital Systems