UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061229 |
|---|---|
| Receipt number | R000070065 |
| Scientific Title | Development of the Peer Support Function Scale for Older Adults Requiring Long-Term Care |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/10 17:19:24 |
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Basic information
Public title
Development of the Peer Support Function Scale for Older Adults Requiring Long-Term Care
Acronym
Development of the Peer Support Function Scale for Older Adults Requiring Long-Term Care
Scientific Title
Development of the Peer Support Function Scale for Older Adults Requiring Long-Term Care
Scientific Title:Acronym
Development of the Peer Support Function Scale for Older Adults Requiring Long-Term Care
Region
| Japan |
Condition
Condition
Older adults requiring long-term care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a peer support function scale applicable to older adults requiring long-term care who use day-care rehabilitation or day-care services, based on the existing Peer Support Function Scale. First, the items will be modified through a focus group of experts and content validity assessment. After confirming face validity among service users, a multicenter cross-sectional survey will be conducted. Using the collected data, the factor structure, internal consistency, test-retest reliability, and measurement error of the scale will be examined, and interpretability will be explored through its association with the SF-8.
Basic objectives2
Others
Basic objectives -Others
Development of a peer support function scale for older adults requiring long-term care and validation of its psychometric properties
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Structural validity and reliability of the peer support function scale for older adults requiring long-term care (exploratory factor analysis, confirmatory factor analysis, internal consistency, and test-retest reliability)
Key secondary outcomes
1. Content validity (CVR, I-CVI, and S-CVI/Ave)
2. Face validity
3. Measurement error
4. Association between each factor score and the SF-8
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Aged 65 years or older
2. Either sex
3. Independence level in daily living for older adults with dementia is level I or no cognitive problem
4. Has been using the current day-care rehabilitation or day-care service for more than 3 months
5. Provides informed consent personally
Key exclusion criteria
1. Severe visual or hearing impairment
2. Requires acute medical management
3. Is in the terminal stage or receiving palliative care
4. Japanese is not the first language
Target sample size
182
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Ishigaki |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745-54-1601
t.ishigaki@kio.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Ishigaki |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745-54-1601
Homepage URL
t.ishigaki@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Meiji Yasuda Life Foundation of Health and Welfare
IRB Contact (For public release)
Organization
Research Ethics Committee, Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
Tel
0745-54-1601
kansa@kio.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 10 | 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
| 2026 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter observational study primarily uses a cross-sectional design to develop a Peer Support Function Scale for older adults requiring long-term care. First, nine experts in long-term care support and qualitative research will review the existing scale through a focus group to assess relevance, comprehensiveness, and comprehensibility, and to revise items as needed. Second, content validity will be evaluated using the CVR, I-CVI, and S-CVI/Ave. Third, face validity will be examined among users at participating institutions. Finally, a multicenter cross-sectional survey will be conducted using the revised draft scale. Eligible participants are adults aged 65 years or older who require long-term care, use day-care rehabilitation or day-care services, have an independence level in daily living for older adults with dementia of level I or no cognitive problem, have used the service for more than 3 months, and provide written informed consent. Participants will be recruited by therapists or other staff without a direct conflict of interest. Recruitment will continue from ethics approval until March 31, 2028. Variables include age, sex, height, weight, primary diagnosis, mental disorder, independence in daily living, household composition, co-payment rate, years of service use, Charlson Comorbidity Index, walking independence, dementia-related independence level, the peer support scale, and SF-8. To assess test-retest reliability, some participants will complete the scale again about 2 weeks later.
Management information
Registered date
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070065
