UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058703 |
|---|---|
| Receipt number | R000066595 |
| Scientific Title | A Study Investigating the Relationship between Affiliation Motivation and Health Literacy and Their Longitudinal Outcomes in Elderly Users of Day Rehabilitation Services |
| Date of disclosure of the study information | 2025/08/22 |
| Last modified on | 2025/08/05 18:14:49 |
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Basic information
Public title
Study on the Relationshipp between Affiliation Motivation and Health Literacy in Elderly Users of Day Rehabilitation Services
Acronym
AffMot-HL Study
Scientific Title
A Study Investigating the Relationship between Affiliation Motivation and Health Literacy and Their Longitudinal Outcomes in Elderly Users of Day Rehabilitation Services
Scientific Title:Acronym
AM-HL DayReha Study
Region
| Japan |
Condition
Condition
Elderly with chronic conditions
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify how psychosocial factors such as affinity motivation and loneliness are related to health literacy among elderly people requiring care who use day-care rehabilitation. We will also explore the mediating effect of acceptance of peer support among users who share the same position and experience on the association between affinity motivation and health literacy. In addition, we will conduct a longitudinal analysis of the impact of baseline health literacy on subjective health perceptions one year later to determine the clinical significance of health literacy and its association with maintaining health status and preventing serious illness
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate the associations between psychosocial factors-such as affiliation motivation, loneliness, and peer support-and health literacy in elderly individuals using day rehabilitation services. It also examines the longitudinal impact of baseline health literacy on subjective health status after one year.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health literacy score measured by HLS-Q12 at baseline and at 12-month follow-up
Key secondary outcomes
Affiliation Motivation Scale score (measured at baseline and 12-month follow-up)
UCLA Loneliness Scale score (measured at baseline and 12-month follow-up)
Peer Support Function Scale score (measured at baseline and 12-month follow-up)
Subjective health status (4-point Likert scale) (measured at baseline and 12-month follow-up)
HDS-R score (cognitive function) (measured at baseline and 12-month follow-up)
Basic characteristics (age, sex, BMI, educational attainment, care level, participation in community activities) (measured at baseline and 12-month follow-up)
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
Elderly persons requiring nursing care (requiring nursing care 1 or more) who are using day-care rehabilitation services as of June 2025 are eligible.
Inclusion Criteria
- Persons who understand the content of this study and give consent to participate
- Persons who have been certified as requiring long-term care (requiring long-term care 1 or more)
- Persons who are 65 years of age or older
Key exclusion criteria
Exclusion Criteria.
- Persons with moderate or severe dementia (HDS-R less than 20 points)
- Patients under palliative care
- Persons with functional disabilities that interfere with questionnaire response
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YUTA |
| Middle name | |
| Last name | HIRAKAWA |
Organization
Aomi Geriatric Health Care Facility, JA Aichi Koseiren.
Division name
no
Zip code
446-8602
Address
Higashihirokute, Anjo Town, Anjo City, Aichi Prefecture, Japan.
TEL
0566-75-8460
ytbbang@yahoo.co.jp
Public contact
Name of contact person
| 1st name | YUTA |
| Middle name | |
| Last name | HIRAKAWA |
Organization
Aomi Geriatric Health Care Facility, JA Aichi Koseiren.
Division name
no
Zip code
446-8602
Address
Higashihirokute, Anjo Town, Anjo City, Aichi Prefecture, Japan.
TEL
0566-75-8460
Homepage URL
ytbbang@yahoo.co.jp
Sponsor or person
Institute
Graduate School, Kio University
Institute
Department
Personal name
Funding Source
Organization
Graduate School, Kio University
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
Aomi Geriatric Health Care Facility, JA Aichi Koseiren.
Address
Higashihirokute, Anjo Town, Anjo City, Aichi Prefecture, Japan.
Tel
0566-75-8460
ytbbang@yahoo.co.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
| 2025 | Year | 08 | Month | 22 | 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
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | 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
Cross-sectional analysis will use Pearson's correlation analysis and multiple regression analysis to examine the relationship between affinity motivation, loneliness, and HL. In addition, analysis using social interaction as a mediating factor will be conducted to clarify the direct and indirect effects of affinity motivation and loneliness on HL. Longitudinal analysis will use logistic regression or linear regression to analyze the effect of baseline HL on subjective health one year later.
Translated with DeepL.com (free version)
Management information
Registered date
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066595
