UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060606 |
|---|---|
| Receipt number | R000069323 |
| Scientific Title | Development of the Affiliation Motivation Scale for Older Adults Requiring Long-Term Care |
| Date of disclosure of the study information | 2026/02/06 |
| Last modified on | 2026/02/06 16:24:25 |
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Basic information
Public title
Development of the Affiliation Motivation Scale for Older Adults Requiring Long-Term Care
Acronym
Affiliation Motivation Scale for Long-Term Care older adults
Scientific Title
Development of the Affiliation Motivation Scale for Older Adults Requiring Long-Term Care
Scientific Title:Acronym
Affiliation Motivation Scale for Long-Term Care older adults
Region
| Asia(except Japan) |
Condition
Condition
Older adults requiring long-term care who use outpatient/day-care rehabilitation (day-care rehab) or day-care services in Japan
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an affiliation motivation measurement scale tailored to older adults requiring long-term care by examining and refining an existing 26-item affiliation motivation scale (four social reward domains: emotional support, positive stimulation, social comparison, and attention), and to evaluate its psychometric properties (factor structure, reliability, and measurement error) in users of day-care rehabilitation/day-care services.
Basic objectives2
Others
Basic objectives -Others
Multicenter observational study with a cross-sectional survey design; for test-retest reliability, the affiliation motivation questionnaire is re-administered approximately one week after the first response.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Construct validity of the affiliation motivation scale for older adults requiring long-term care: factor structure identified by exploratory factor analysis (EFA) and confirmed by confirmatory factor analysis (CFA) with model fit evaluation.
Reliability and measurement properties: internal consistency (Cronbach's alpha), test-retest reliability, and measurement error.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 65 years or older
Cognitive status: Independence level in daily living for older adults with dementia is Level I or no problem (largely independent in daily life)
Has been using day-care rehabilitation or day-care services for more than 3 months
Written informed consent obtained from the participant
Key exclusion criteria
Severe visual or hearing impairment
Requires acute medical management
End-of-life status or receiving palliative care
Japanese is not the participant's first language
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Ishigaki |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, 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
Faculty 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
The principal investigator's internal/personal research funds, and a grant from the Daido Life Welfare Foundation (planned).
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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 | 02 | Month | 06 | 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 | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter observational study with a prospective cross-sectional design. Participants are older adults (aged >=65 years) requiring long-term care who use day-care rehabilitation and/or day-care services. Eligibility includes: service use for more than 3 months, cognitive status classified as Level I (or "no problem") on the Japanese "Independence level in daily living for older adults with dementia," and written informed consent provided by the participant. Exclusion criteria are: severe visual/hearing impairment, need for acute medical management, end-of-life status or receiving palliative care, and Japanese not being the participant's first language.
At each site, questionnaires and baseline characteristics (e.g., age, sex, primary diagnosis, comorbidity index, walking independence, cognitive status indicator, and social support) are collected, and the affiliation motivation questionnaire is re-administered approximately one week later for test-retest assessment. Data are managed as pseudonymized data at each site (with a linkage key retained locally) and transferred to the coordinating institution in a format that does not allow direct identification. A centralized integrated database is then used for analysis.
The primary analyses aim to develop an affiliation motivation scale tailored to older adults requiring long-term care by examining its factor structure (exploratory factor analysis and confirmatory factor analysis) and evaluating reliability (internal consistency and test-retest reliability) and measurement error. As a secondary analysis, the positivity of responses regarding group rehabilitation is treated as the outcome, and associations with factors such as physical function, social support, and affiliation motivation scores are examined using logistic regression. Sampling is based on a consecutive (convenience) sample of eligible service users at participating sites.
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069323
