Culture-Based Multicomponent Cognitive Training Program

Nursing Caries Clinical Trial

Official title:

Feasibility of a Culture-Based Multicomponent Cognitive Training Program in Older People With Dementia: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06090188
• Other study ID #: NTJCN 1121003
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2023
• Source: National Tainan Junior College of Nursing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Nursing Caries

Intervention

Other:
• A 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.

Locations

Country	Name	City	State
Taiwan	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

Sponsors (1)

Lead Sponsor	Collaborator
National Tainan Junior College of Nursing

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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