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Clinical Trials/NCT04615169
NCT04615169
Completed
Not Applicable

Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities

National Cheng Kung University1 site in 1 country140 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Training
Sponsor
National Cheng Kung University
Enrollment
140
Locations
1
Primary Endpoint
Kihon Checklist-Taiwan (KCL)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
December 31, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ling-Hui Chang

Associate Professor

National Cheng Kung University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • People with non-cognitive issues, such as severe visual, hearing, or physical impairments, that interfered with completion of evaluations.

Outcomes

Primary Outcomes

Kihon Checklist-Taiwan (KCL)

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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