UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048858 |
|---|---|
| Receipt number | R000055648 |
| Scientific Title | Psychosocial effects of activity care on dementia |
| Date of disclosure of the study information | 2022/09/05 |
| Last modified on | 2023/12/12 12:02:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Psychosocial effects of activity care on dementia
Acronym
Psychosocial effects of activity care on dementia
Scientific Title
Psychosocial effects of activity care on dementia
Scientific Title:Acronym
Psychosocial effects of activity care on dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reliability and validity of the Japanese version of the Greater Cincinnati Chapter Well-Being Observation Tool in assessing the psychosocial effect of activity care overall.
Basic objectives2
Others
Basic objectives -Others
To investigate the effectiveness of each type of activity care in older adults.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Greater Cincinnati Chapter Well-Being Observation Tool, a tool focusing on the psychosocial effect of activity care and art therapy for dementia, developed by Rentz (Japanese version, Kawakubo).
Key secondary outcomes
Mini-Mental State Examination (MMSE) measured prior to art therapy, coloring, and activity interventions, Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) with interviews with care staff, short health-related quality of life for older adults with dementia (QOL-D), NPI-NH and short QOL-D 6 weeks after intervention. NPI-NH and short QOL-D 12 weeks after intervention. MMSE, NPI-NH, and short QOL-D measured 18 weeks after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Art therapy (clinical art)implementation method Clinical artists will conduct sessions with six different clinical art programs. Facilitators (clinical artists) will conduct sessions once a week, limited to 40 minutes.6weeks.
Interventions/Control_2
Coloring implementation method A time for coloring will be set once a week in the day room, when the older adults will color pictures. The coloring will be left to the free will of the older adults, as is done routinely, and at the end of the session.6weeks.
Interventions/Control_3
Activity implementation method
Six different activities games, playing with balls, reminiscence therapy, music, exercise, and cognitive rehabilitation will be conducted by care staff with small groups of older adults. 6weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People with classification level1or higher for independence in daily life for older adults with dementia, people 65 or older who have been diagnosed with dementia and have mild to moderate cognitive impairment (older adults with dementia independence classification level1-2,Clinical Dementia Rating(CDR)<=2).Pople who can hold aconversation.People who use facilities for older adults.People themselves or whose family gave consent are planned as subujects.
Key exclusion criteria
people with visual hallucinations, severe hearing loss, severe visual impairment, or unstable physical condition.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakukubo |
Organization
Josai International University
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyou,Togane-shi,Chiba
TEL
0475-55-7041
kawakubo@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakubo |
Organization
Josai International University
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyo,Togane-shi,Chiba
TEL
0475-55-7041
Homepage URL
kawakubo@jiu.ac.jp
Sponsor or person
Institute
Josai International University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Reserch(C)(FY2022-2024)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Gunma University
Name of secondary funder(s)
SOYOKAZE Co., Ltd. former Unimat Retirement Community Co., Ltd.
IRB Contact (For public release)
Organization
The Ethics committee of Josai International University
Address
1 Gumyo,Togane-shi,Chiba
Tel
0475-55-7832
research-c@jiu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社ユニマット リタイアメント・コミュニティのグループホーム
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 08 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 23 | Day |
Other
Other related information
Statistical analysis Study1: SPSS ver.26 statistical analysis software will be used. Descriptive statistics, reliability, and validity will be investigated. The tool scores for each activity will be compared for responsiveness and interpretability. Cronbach's alpha coefficient will be calculated for the Japanese version of the GCCWBOT overall,and internal consistency will be obtained. Intraclass correlation coefficients between 2 raters will be calculated for 7 domains. A factor analysis of the Japanese version of the GCCWBOT will be conducted. Consistency between these results and the results of factor analysis with the English version of the GCCWBOT will be investigated, and the construct validity of the Japanese version of the GCCWBOT will be checked.
Study2: Investigation of the effectiveness of each type of activity care in older adults.
Verification of activity care effectiveness.
Verification in before and after groups, and intergroup comparison of different activities
Statistical analysis:After investigating descriptive statistics, reliability, and validity, the scores on the tool for each type of activity will be compared for responsiveness and interpretability. Tool score differences will be investigated by the level of dementia and the age of the older adults. The differences in score on the NPI-NH and short QOL-D will also be investigated.
Management information
Registered date
| 2022 | Year | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055648
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
