Nursing CariesNCT06090188
Culture-Based Multicomponent Cognitive Training Program
A study testing A Culture-Based Multicomponent Cognitive Training Program in people with Nursing Caries, run by National Tainan Junior College of Nursing at 4 sites in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Nursing Caries
- What is being tested?
- A Culture-Based Multicomponent Cognitive Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Apr 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Ah Lian Day Care Center
Kaohsiung City
Anping Day Care Center
Tainan
Huishan community long-term care institution
Tainan
Meiyu East District Day Care Center
Tainan
About this study
Official title: Feasibility of a Culture-Based Multicomponent Cognitive Training Program in Older People With Dementia: A Randomized Controlled Pilot Study
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.
- Conditions
- Nursing Caries
- Being tested
- A Culture-Based Multicomponent Cognitive Training Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Culture-Based Multicomponent Cognitive Training ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: A Culture-Based Multicomponent Cognitive Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline, 8 weeks post-intervention, 16 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Apr 2021
- Primary completion31 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Tainan Junior College of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-Hsien Chang, National Tainan Junior College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090188
- Sponsor's protocol ID
- NTJCN 1121003
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Culture-Based Multicomponent Cognitive Training Program in Older People With Dementia: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06090188
- Acronym / sponsor ID
- NTJCN 1121003
- Conditions
- Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Tainan Junior College of NursingUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: A Culture-Based Multicomponent Cognitive Training ProgramSubjects 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. |
| comparison group | Active comparator | Other: A Culture-Based Multicomponent Cognitive Training ProgramParticipants in the comparison group received these activities via two RAs and day care caregivers for 16 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Culture-Based Multicomponent Cognitive Training ProgramActivities 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. | Other | comparison group, experimental group |
Primary outcome
Cognitive function
Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
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).
Behavioural problems
Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
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).
Symptoms of depression
Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
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).
Self-care abilities
Time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Culture-Based Multicomponent Cognitive Training Program in people with Nursing Caries, run by National Tainan Junior College of Nursing at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: baseline, 8 weeks post-intervention, 16 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.