UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063536 |
|---|---|
| Receipt number | R000072719 |
| Scientific Title | A Study on the Development of a Peer Support Function Scale for Older Adults Requiring Long-Term Care |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 20:12:15 |
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Basic information
Public title
A Study on the Development of a Peer Support Function Scale for Older Adults Requiring Long-Term Care
Acronym
A Study on the Development of a Peer Support Function Scale for Older Adults Requiring Long-Term Care
Scientific Title
A Study on the Development of a Peer Support Function Scale for Older Adults Requiring Long-Term Care
Scientific Title:Acronym
A Study on the Development of a Peer Support Function Scale for Older Adults Requiring Long-Term Care
Region
| Japan |
Condition
Condition
Individuals who are 65 years of age or older, have no cognitive impairments, and have been receiving day rehabilitation or day care services for more than three months
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the Peer Support Function Scale a questionnaire designed to assess the dynamics of mutual support among service users can be appropriately applied to individuals receiving outpatient rehabilitation and outpatient long-term care services.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire on Peer Support Function Scale and Quality of Life (QOL)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Elderly individuals aged 65 or older who require long term care, are currently receiving outpatient rehabilitation or outpatient care services at a designated facility, have no cognitive impairments, and have been receiving these services for more than three months.
Key exclusion criteria
Individuals with significant hearing and visual impairment,individuals requiring acute medical care, individuals in the end of life stage or receiving palliative care, and individuals whose first language is not Japanese
Target sample size
182
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Kato |
Organization
Kawaguchi Neurosurgery and Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
202-25-9, Kariyono-cho, Hirakata City, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgery and Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
202-25-9, Kariyono-cho, Hirakata City, Osaka
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery and Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawaguchi Neurosurgery and Rehabilitation Clinic
Address
202-25-9, Kariyono-cho, Hirakata City, Osaka
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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 | 11 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will conduct focus group discussions on the existing peer support function scale with a group of participants that includes not only those with practical experience in supporting older adults requiring long term care but also those with experience in qualitative research. During the focus groups, we will examine each item from the perspectives of relevance, comprehensiveness, and understandability. Based on the feedback received, we will revise the wording of items as necessary and remove any unnecessary items.
Next, we will re evaluate the content validity of each revised item. Specifically, we will calculate the content validity ratio and the item level content validity index for each item, using a threshold of 0.78 or higher for both. Furthermore, to confirm the content validity of the scale as a whole, we will calculate the scale level content validity index to verify the scale overall validity.
Subsequently, for the draft scale revised following the content validity review, face validity will be assessed among users at each facility. A 5 point Likert scale will be used to evaluate face validity, and respondents will be asked to rate the clarity of each item meaning and wording. The mean score for each item will be calculated, and face validity will be evaluated using a reference value of 3 or higher.
Management information
Registered date
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072719
