UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036731 |
|---|---|
| Receipt number | R000041851 |
| Scientific Title | Reliability and Validity of a Japanese Version of The Greater Cincinnati Chapter Well-Being Observation Tool with a Focus on the Psychosocial Effects on Dementia |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2023/03/16 19:32:17 |
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Basic information
Public title
Reliability and Validity of a Japanese Version of The Greater Cincinnati Chapter Well-Being Observation Tool with a Focus on the Psychosocial Effects on Dementia
Acronym
Reliability and Validity of a Japanese Version of The Greater Cincinnati Chapter Well-Being Observation Tool
Scientific Title
Reliability and Validity of a Japanese Version of The Greater Cincinnati Chapter Well-Being Observation Tool with a Focus on the Psychosocial Effects on Dementia
Scientific Title:Acronym
Reliability and Validity of a Japanese Version of The Greater Cincinnati Chapter Well-Being Observation Tool
Region
| Japan |
Condition
Condition
Undergraduate and postgraduate students
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the reability and validity of a Japanese version of The Greater Cincinnati Chapter Well-Being Observation Tool.
Basic objectives2
Others
Basic objectives -Others
To taranslate The Greater Cincinnati Chapter Well-Being Observation Tool to Japanese
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Greater Cincinnati Chapter Well-Being Observation Tool
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergraduate and postgraduate students,Josai International University,Gunma University,majoring in health care medical welfare
Key exclusion criteria
None
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Ohyama |
Organization
Graduate School of Health Sciences,Gunma University
Division name
Nursing
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8932
ohyamay@gunma-u.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
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Josai International University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Reserch Involving Human Subjects
Address
3-39-22 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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
城西国際大学（千葉県）Josai International University、群馬大学（群馬県）Gunma University
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.rounenkango.com
Number of participants that the trial has enrolled
40
Results
Cronbach's Alfa coefficient for the entire Japanese version of the tool was 0.852. Intra-rater reliability, Pearson's correlation coefficients of the 7 domains were between 0.900 and 0.704. When intra-rater reliability was tested, the interclass correlation coefficient of the seven domains was between 0.292 and 0.590. Factor analysis of the 7 domains was conducted, and two factors were identified. These results coincided with the results of the factor analysis of the English version of the tool.
Results date posted
| 2022 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects: Three nursing care insurance facilities for elderly persons in Prefecture A, A total of 37 elderly patients with mild to moderate dementia, [Clinical Dementia Rating (CDR) <=2] and who were deemed mentally and physically able to participate in visual art therapy sessions. (12 male and 25 female subjects whose mean age was 86.9 Plus or minus 6.9 years.)
Raters: Forty students who gave written consent were recruited as raters.
Of the 40 raters, there were three men and 37 women (age 21.4 Plus or minus 1.0 years). They were all students majoring in nursing.
Participant flow
The Japanese version of the tool was developed to consist of 19 indicators and 7 domains. A total of 37 elderly patients with mild to moderate dementia participated in six types of visual art therapy sessions, and two raters evaluated the condition of the elderly dementia patients during the sessions using the Japanese version of the tool.
Adverse events
None
Outcome measures
coefficient (ICC) of the scores for two raters. Furthermore, the absolute value of the difference in scores between two raters was calculated, and the percentage of the score difference being 1 or less was obtained.An exploratory factor analysis was conducted to identify intrinsic potential factors among the observed variables. The level of significance was set at 5% for all tests.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 01 | Day |
Other
Other related information
To investigate the developed Japanese version for its reliability and validity, elderly people with dementia (total of 37people) engaged in art therapy will be recorded on video. The well-trained 40 undergraduate and postgraduate students will evaluate the actions, speech, and behavior every 10 minutes of the elderly people on video recordings. The two students will evaluate the same elderly people independently. The developed Japanese version filled out by the students will be analyzed to examine the reliability and validity of the tool. The software SPSS ver. 25 will be used for statistical analysis. To analyze items, the presence or absence of ceiling and floor effects for the 19-item Japanese tool will be examined. An exploratory factor analysis will be conducted to examine the content and factor loading of each item. I-T correlations and Cronbach's alphas will be calculated by analyzing the reliability of the entire tool and of each domain. The same evaluator will perform a re-test. The difference in score between 2 evaluators will be examined.
Management information
Registered date
| 2019 | Year | 05 | Month | 13 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041851
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