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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036731
Receipt No. 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 2019/05/13

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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
Email 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
Email kawakubo@jiu.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Email 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
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 Preinitiation
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
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate the developed Japanese version for its reliability and validity, elderly people with dementia (total of 18 people) engaged in art therapy will be recorded on video. The well-trained 36 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
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041851

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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