NCT06090188

Brief Summary

To provide care without exacerbating behavioral and psychological problems and preventing functional decline, a multi-component, cognitive training program was designed. The purpose of this study is to test the effectiveness of this multi-component, cognitive training program in day care centers for elderly people with dementia to prevent cognitive function decline, self-care abilities decline, and behavior problems or the development of depressive moods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 4, 2023

Last Update Submit

October 16, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cognitive function

    The Mini-Mental State Examination (MMSE) was used to measure the cognitive status of the participants. It was collected through individual interviews. The MMSE is a criterion-referenced instrument that contains 11 items. It can be used to examine a person's orientation, registration, recall, attention, calculation ability, understanding and use of language, and praxis. The score ranges from 0 to 30. The sum of the score is used to stratify cognitive function (Crun, Anthony, Bassett, \& Folstein, 1993).

    baseline, 8 weeks post-intervention, 16 weeks post-intervention

  • Behavioural problems

    The Clifton Assessment Procedures for the Elderly - Behaviour Rating Scale (CAPE-BRS) was used to measure behavioural problems, including activities of daily living, apathy, communication difficulties, and social disturbance. It was collected by observations. The CAPE-BRS includes 18 items; each item is scored from 0 to 2. The total score ranges from 0 to 36. Higher scores indicate greater disability (Pattiem \& Gilleard, 1979).

    baseline, 8 weeks post-intervention, 16 weeks post-intervention

  • Symptoms of depression

    The Cornell Scale for Depression in Dementia (CSDD) was used to examine symptoms of depression. It was collected by observations. It includes 19 items and measures mood-related signs, behavioural disturbances, physical signs, cyclic functioning, and ideational disturbance. The total score ranges from 0 to 38. A score from 0 to 6 indicates no depression, 7 to 9 indicates mild depression, 10 to 19 indicates possible severe depression, and 18 and over indicates severe depression. The CSDD has been translated into Chinese, and the validity and reliability have been examined (Sharp \& Lipsky, 2002).

    baseline, 8 weeks post-intervention, 16 weeks post-intervention

  • Self-care abilities

    The Refined ADL Assessment Scale (RADL) was used in this study to measure the performance of activities of daily living (ADLs). It was collected by observations. The RADL is designed to measure 5 tasks of basic ADLs for older adults with Alzheimer's and related disorders. It includes tasks of feeding, washing, grooming, dressing, and toileting. The toileting task was not assessed in this study because it was likely to disturb the privacy of older adults. Each task in the RADL is broken down into 2 to 5 subtasks. Each subtask is further broken down into the sequence of steps needed for the completion of the activity. The scores for the feeding activity range from 0 to 126, for the washing activity range from 0 to 204, for the grooming activity range from 0 to 174, and for the dressing activity range from 0 to 150. A higher score indicates greater independence in ADL performance.

    baseline, 8 weeks post-intervention, 16 weeks post-intervention

Study Arms (2)

experimental group

EXPERIMENTAL

Subjects in the experimental group received a series of culture-based multicomponent cognitive training activities via research assistants (RAs) and caregivers of the centres for 8 weeks, then provided by caregivers of the day care centre for 8 weeks with RAs providing assistance with the activity process.

Other: A Culture-Based Multicomponent Cognitive Training Program

comparison group

ACTIVE COMPARATOR

Participants in the comparison group received these activities via two RAs and day care caregivers for 16 weeks.

Other: A Culture-Based Multicomponent Cognitive Training Program

Interventions

Activities of the program were structured, cognitive, leisure activities based on Chinese and Taiwanese culture for cognitively impaired older people. Activities contained structured brain-exercise activities and musical activities. The structured brain-exercise activities included playing musical instruments or singing, playing board games, and classes in Chinese, sciences, sociology, physical education, cooking, and math. Chinese and Taiwanese cultures were included within the structured brain-exercise activities curriculum, such as food, clothing, architecture, places of interest, folklore, etiquette, celebrations, religion, art, etc. Participants began with a musical exercise, then had 20-30 minutes of physical exercise with 5 minutes of warm-up at the beginning and 5 minutes of cool down. The program was provided for at least 40-60 minutes, twice a week, for 8 weeks via RAs and day centre caregivers.

comparison groupexperimental group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • persons aged 60 years and over, (2) living in their own home, (3) with or without a hearing device and able to speak Mandarin or Taiwanese, (4) attending a day care centre at least three days per week, (5) cognitively impaired as determined by a score of 22 or lower on the Mini-Mental State Examination (MMSE), and (6) self or legal proxy agreed to participate in the study.

You may not qualify if:

  • \- Persons were excluded if they were bedridden and unable to sit in a wheelchair or had one or more acute illnesses during the data collection period causing them to be unable to return to the day care centre.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ah Lian Day Care Center

Kaohsiung City, Taiwan

Location

Anping Day Care Center

Tainan, Taiwan

Location

Huishan community long-term care institution

Tainan, Taiwan

Location

Meiyu East District Day Care Center

Tainan, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 19, 2023

Study Start

April 1, 2021

Primary Completion

January 31, 2022

Study Completion

March 31, 2022

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations