Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-04 @ 7:45 AM
Study NCT ID:
NCT04615169
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
Sponsor:
National Cheng Kung University
Organization:
Study Overview
Official Title:
Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
This study discusses the feasibility, implementation, and preliminary effectiveness of an evidence-driven, multi-component cognitive intervention using simulated everyday tasks (MCI-SET) for cognitively-vulnerable older adults in community organizations in two cities in southern Taiwan.
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.
This study discusses the feasibility, implementation, and preliminary effectiveness of an evidence-driven, multi-component cognitive intervention using simulated everyday tasks (MCI-SET) for cognitively-vulnerable older adults in community organizations in two cities in southern Taiwan.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: