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

NCT04615169 | Completed

• 1 other identifier: National Cheng Kung University
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Training; Dementia; Occupational Therapy; Aging; Long Term Care

Keywords

cognitive training; dementia prevention; Dementia; occupational therapy; community based practice; older people; long term care

Outcome Measures

Primary Outcomes (6)

• Kihon Checklist-Taiwan (KCL)

  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 before the start of intervention

• Kihon Checklist-Taiwan (KCL)

  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)

  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

  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 before the start of intervention

• General Cognition

  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

  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 Outcomes (9)

• Functional episodic memory

  up to one month before the start of intervention

• Functional episodic memory

  up to one month after the end of intervention

• Functional episodic memory

  up to 4 months 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

Study Arms (1)

multi-component cognitive intervention using simulated everyday tasks (MCI-SET)

EXPERIMENTAL

the 12-week intervention, 2 hours weekly session of MCI-SET.

Behavioral: Multi-component cognitive intervention with simulated everyday tasks (MCI-SET)

Interventions

Multi-component cognitive intervention with simulated everyday tasks (MCI-SET) BEHAVIORAL

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.

multi-component cognitive intervention using simulated everyday tasks (MCI-SET)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng-Kung University

Tainan, 701, Taiwan

Location

Related Publications (1)

• Mao HF, Tsai AY, Chang LH, Tsai IL. Multi-component cognitive intervention for older adults with mixed cognitive levels: implementation and preliminary effectiveness in real-world settings. BMC Geriatr. 2021 Oct 12;21(1):543. doi: 10.1186/s12877-021-02489-z.

  PMID: 34641803 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ling-Hui Chang, Ph.D

  National Cheng Kung University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A multi-center one-group pretest, post-test, and 3-month follow up design

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 4, 2020
• Study Start: August 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)