- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615169
Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tainan, Taiwan, 701
- National Cheng-Kung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: multi-component cognitive intervention using simulated everyday tasks (MCI-SET)
the 12-week intervention, 2 hours weekly session of MCI-SET.
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2 hours per session: consisted primarily of modified everyday cognitive tasks, which were adjusted for individuals and for the group by the group leader to provide an error-reduction learning environment. Each session consisted of: (1) Warm-up: a 15-30 minute dual task of motor-cognitive exercises that increase arousal level and provide cognitive stimulation. For example, at the beginning of the group, the members would sing a song, mimic dance movement of the group leader, and clap hands when specific words occur in the song. (2) 30-minutes guided and repetitive practices of contextually-relevant simulated everyday cognitive tasks with one 15 to 20- minute break in between; Cognitive tasks addressed complex attention, visual scanning, auditory attention, visual and motor memory, auditory memory, prospective memory, executive functioning, problem solving, etc. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kihon Checklist-Taiwan (KCL)
Time Frame: 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.
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up to one month before the start of intervention
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Kihon Checklist-Taiwan (KCL)
Time Frame: 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.
|
up to one month after the end of intervention
|
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.
|
up to 4 months after the end of intervention
|
General Cognition
Time Frame: 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.
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up to one month before the start of intervention
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General Cognition
Time Frame: 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.
|
up to one month after the end of intervention
|
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.
|
up to 4 months after the end of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional episodic memory
Time Frame: up to one month before the start of intervention
|
Functional episodic memory was assessed by using the event-based task in Miami Prospective Memory Test (MPMT).
The participants were asked to pick up an envelope on the desk, get a fixed amount of paper bills from the envelope, give one bill to the examiner and put another one in another envelope when an alarm sounds in 30 minutes later.
A total score ranges from 0-9 from three sub-scores of "intention to perform, accuracy, and need for reminders."
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up to one month before the start of intervention
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Functional episodic memory
Time Frame: up to one month after the end of intervention
|
Functional episodic memory was assessed by using the event-based task in Miami Prospective Memory Test (MPMT).
The participants were asked to pick up an envelope on the desk, get a fixed amount of paper bills from the envelope, give one bill to the examiner and put another one in another envelope when an alarm sounds in 30 minutes later.
A total score ranges from 0-9 from three sub-scores of "intention to perform, accuracy, and need for reminders."
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up to one month after the end of intervention
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Functional episodic memory
Time Frame: up to 4 months after the end of intervention
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Functional episodic memory was assessed by using the event-based task in Miami Prospective Memory Test (MPMT).
The participants were asked to pick up an envelope on the desk, get a fixed amount of paper bills from the envelope, give one bill to the examiner and put another one in another envelope when an alarm sounds in 30 minutes later.
A total score ranges from 0-9 from three sub-scores of "intention to perform, accuracy, and need for reminders."
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up to 4 months after the end of intervention
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short-term memory and working memory
Time Frame: up to one month before the start of intervention
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Wechsler Adult Intelligence Scale-IV Digit Span subtest (Digits Forward, DF, and Digits Backwards, DB) measure short-term memory (DF) and working memory (DB).
Participants listened to a sequence of digits and were asked to recall the sequence correctly (DF) or in reverse-order (DB).
Total scores ranged from 2-9 for DF and 2-8 for DB
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up to one month before the start of intervention
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short-term memory and working memory
Time Frame: up to one month after the end of intervention
|
Wechsler Adult Intelligence Scale-IV Digit Span subtest (Digits Forward, DF, and Digits Backwards, DB) measure short-term memory (DF) and working memory (DB).
Participants listened to a sequence of digits and were asked to recall the sequence correctly (DF) or in reverse-order (DB).
Total scores ranged from 2-9 for DF and 2-8 for DB
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up to one month after the end of intervention
|
short-term memory and working memory
Time Frame: up to 4 months after the end of intervention
|
Wechsler Adult Intelligence Scale-IV Digit Span subtest (Digits Forward, DF, and Digits Backwards, DB) measure short-term memory (DF) and working memory (DB).
Participants listened to a sequence of digits and were asked to recall the sequence correctly (DF) or in reverse-order (DB).
Total scores ranged from 2-9 for DF and 2-8 for DB
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up to 4 months after the end of intervention
|
Attention and executive Functioning
Time Frame: up to one month before the start of intervention
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Attention and executive Functioning was measured by Color Trail Test Part 1 (CTT-1)(attention) and Part 2 (CTT-2) (executive function) (D'Elia, Satz, Uchiyama, & White, 1996).
Participants were asked to connect 25 numbered circles as quickly as possible.
Their tests are timed in seconds.
The shorter time indicates better performance.
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up to one month before the start of intervention
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Attention and executive Functioning
Time Frame: up to one month after the end of intervention
|
Attention and executive Functioning was measured by Color Trail Test Part 1 (CTT-1)(attention) and Part 2 (CTT-2) (executive function) (D'Elia, Satz, Uchiyama, & White, 1996).
Participants were asked to connect 25 numbered circles as quickly as possible.
Their tests are timed in seconds.
The shorter time indicates better performance.
|
up to one month after the end of intervention
|
Attention and executive Functioning
Time Frame: up to 4 months after the end of intervention
|
Attention and executive Functioning was measured by Color Trail Test Part 1 (CTT-1)(attention) and Part 2 (CTT-2) (executive function) (D'Elia, Satz, Uchiyama, & White, 1996).
Participants were asked to connect 25 numbered circles as quickly as possible.
Their tests are timed in seconds.
The shorter time indicates better performance.
|
up to 4 months after the end of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ling-Hui Chang, Ph.D, National Cheng Kung University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- National Cheng Kung University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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