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CompletedNCT06090188Updated Oct 19, 2023

Culture-Based Multicomponent Cognitive Training Program

An interventional study of A Culture-Based Multicomponent Cognitive Training Program in Nursing Caries, sponsored by National Tainan Junior College of Nursing. Completed at 4 sites in Taiwan. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by National Tainan Junior College of Nursing · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Apr 2021, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed description

The purpose of the 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. This study was a 4-month cluster-randomized controlled trail. Participants who met sample selection criteria were recruited and assigned to either the experimental group or the comparison group, depending on the day-care center they attended. Subjects in the experimental group were received with the multi-component, cognitive training program (MCCTP) via research assistants (RAs) and caregivers of day care center for 8 weeks, then provide by caregivers of day care center for 8 weeks, as well as RAs provided assistance for activity process.

02

Conditions studied

  • Nursing Caries
03

In context

Lead sponsor

National Tainan Junior College of Nursing is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    experimental group

    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

  • Active comparator
    comparison group

    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

  • OtherA Culture-Based Multicomponent Cognitive Training Program

    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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention

  2. 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).

    Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention

  3. 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).

    Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention

  4. 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.

    Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention

07

Study locations

4 sites
  • Ah Lian Day Care Center
    Kaohsiung, Taiwan
  • Anping Day Care Center
    Tainan city, Taiwan
  • Huishan community long-term care institution
    Tainan city, Taiwan
  • Meiyu East District Day Care Center
    Tainan city, Taiwan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06090188
Lead sponsor
National Tainan Junior College of Nursing
Responsible party
Su-Hsien Chang (Professor, National Tainan Junior College of Nursing) — Principal investigator
First posted
Oct 19, 2023
Start date
Apr 1, 2021
Primary completion
Jan 31, 2022
Completion
Mar 31, 2022
Last update
Oct 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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