Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Kihon Checklist-Taiwan (KCL)
研究概览
简要总结
Objective: To assess the feasibility and preliminary effectiveness of an evidence-driven, pragmatic multi-component cognitive intervention with simulated everyday tasks (MCI-SET) with an inclusive group design in community centers Methods: One group, pre-test, post-test, and 3-month follow up research design. The participants who were >=65 and frail, dependence in >= one activity of daily living, or with a confirmed dementia from eight community centers. MCI-SET consisted 12 two-hour weekly group sessions. Feasibility was described with intervention development, fidelity, and acceptability. Outcomes included general daily functioning, general cognition, memory, attention, executive functioning, and processing speed.
详细描述
According to the World Alzheimer Report 2018, 50 million people are living with dementia and the number is expected to triple to 152 million by 2050. Most people at high risk of dementia or with dementia reside in the community. Effective community-based programs can help to maintain functional levels and mitigate or prevent excessive functional decline. There are increasing empirical evidence to support structured and regular cognitive activities as part of brain health lifestyle .
Cognitive intervention is an increasing popular approach that aim to maintain or improve the cognitive functioning of the older adults with or without cognitive impairments. Appropriate cognitive intervention has the potential to change their brain neuro-mechanism. Recent evidence suggests that repeated practices of a carefully designed cognitive exercises with a high degree of similarity with real-life activities of daily living (ADL) (e.g., remembering the instructions for taking prescription medicine, identifying the medicine precautions, etc.) can improve both cognitive skills and cognitive functional performance.
Because of the complexity of cognitive issues people with cognitive impairments encounter, scholars have advocated for a multi-component cognitive intervention that includes more than one approach to make the best use of the individual approaches. The investigators conducted a quasi-experimental study that combined motor-cognitive dual-task exercises with high cognitive demands, cognitive training, and cognitive rehabilitation. The results showed that the intervention can improve cognitive skills and cognitive functional performance for people with mild cognitive impairments.
However, the need to strengthen the research design and to standardize treatment protocols led most cognitive intervention research to target a group of participants with similar cognitive skills, such as those with normal cognition, those with mild cognitive impairments, or those with dementia, etc. This homogeneity in participants is in sharp contrast to what is observed in communities, where most likely the group is inclusive of persons with different levels of cognitive skills. The efficacy of cognitive intervention with an inclusive group design was rarely examined.
Scholars have called for more effort to speed up the process of bridging evidence-based intervention to the everyday settings people live in. Cognitive intervention is in a situation of "leaky pipeline," that is, no systematic examination of how the evidence can be translated, tested in real-world settings (practice), and/or implemented across communities in the continuum of research evidence to widespread implementation. The increasing use of feasibility research design is mostly used as a precursor of randomized clinical trial, examining whether a study protocol requires adjustment, what the barriers and potential strategies are. With the abundance of research that supports the efficacy of cognitive intervention, to the best of the investigators' knowledge, there are no study that investigated the transportability of evidence-based cognitive intervention into the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •equal to or more than 65 years old, and frailty status according to the Study of Osteoporotic Fractures (SOF) criteria of frailty, or dependence with at least one daily activities.
排除标准
- •People with non-cognitive issues, such as severe visual, hearing, or physical impairments, that interfered with completion of evaluations.
研究组 & 干预措施
multi-component cognitive intervention using simulated everyday tasks (MCI-SET)
the 12-week intervention, 2 hours weekly session of MCI-SET.
干预措施: Multi-component cognitive intervention with simulated everyday tasks (MCI-SET) (Behavioral)
结局指标
主要结局
Kihon Checklist-Taiwan (KCL)
时间窗: up to 4 months after the end of intervention
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
General Cognition
时间窗: up to 4 months after the end of intervention
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
Kihon Checklist-Taiwan (KCL)
时间窗: up to one month before the start of intervention
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
Kihon Checklist-Taiwan (KCL)
时间窗: up to one month after the end of intervention
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
General Cognition
时间窗: up to one month before the start of intervention
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
General Cognition
时间窗: up to one month after the end of intervention
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
次要结局
- Functional episodic memory(up to 4 months after the end of intervention)
- short-term memory and working memory(up to 4 months after the end of intervention)
- Attention and executive Functioning(up to 4 months after the end of intervention)
- Functional episodic memory(up to one month before the start of intervention)
- Functional episodic memory(up to one month after the end of intervention)
- short-term memory and working memory(up to one month before the start of intervention)
- short-term memory and working memory(up to one month after the end of intervention)
- Attention and executive Functioning(up to one month before the start of intervention)
- Attention and executive Functioning(up to one month after the end of intervention)
研究者
Ling-Hui Chang
Associate Professor
National Cheng Kung University