UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062722 |
|---|---|
| Receipt number | R000071767 |
| Scientific Title | Classification and Characteristics of Loneliness and Social Support Among Elderly Individuals Requiring Long-Term Care Who Use Day Care Rehabilitation Services: A Focus on Psychosocial Quality of Life |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/28 12:35:25 |
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Basic information
Public title
Classification and Characteristics of Loneliness and Social Support Among Elderly Individuals Requiring Long-Term Care Who Use Day Care Rehabilitation Services: A Focus on Psychosocial Quality of Life
Acronym
Classification and Characteristics of Loneliness and Social Support Among Elderly Individuals Requiring Long-Term Care Who Use Day Care Rehabilitation Services: A Focus on Psychosocial Quality of Life
Scientific Title
Classification and Characteristics of Loneliness and Social Support Among Elderly Individuals Requiring Long-Term Care Who Use Day Care Rehabilitation Services: A Focus on Psychosocial Quality of Life
Scientific Title:Acronym
Classification and Characteristics of Loneliness and Social Support Among Elderly Individuals Requiring Long-Term Care Who Use Day Care Rehabilitation Services: A Focus on Psychosocial Quality of Life
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
This study aims to elucidate how combinations of loneliness and social support among older adults requiring long-term care are typologized into distinct subgroups characterized by differing individual attributes and psychosocial quality of life (QOL). In addition, a preliminary longitudinal investigation will be conducted to examine how loneliness changes over time among individuals belonging to these subgroups through participation in group activities, with the aim of an exploratory analysis that anticipates future research development.
Basic objectives2
Others
Basic objectives -Others
It is hypothesized that alleviation of loneliness and subjective fulfillment derived from social support among older adults requiring long-term care exert a substantial influence on psychosocial quality of life (QOL). Furthermore, it can be hypothesized that establishing venues for group activities among individuals sharing a similar social position (e.g., peer support) serves as a support strategy that contributes to the enhancement of psychosocial QOL.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Loneliness and Social Support
Key secondary outcomes
Age, sex, place of residence, number of cohabiting family members, long-term care insurance copayment ratio, primary diagnosis, Charlson Comorbidity Index (CCI), Body Mass Index (height and weight), long-term care level, Degree of Independence in Daily Living for the Disabled Elderly, Degree of Independence in Daily Living for the Elderly with Dementia, frequency of day-care rehabilitation use, duration of day-care rehabilitation use, level of walking independence, Barthel Index, Frenchay Activities Index, social network, psychosocial quality of life (QOL), health-related quality of life (HRQOL), and interpersonal orientation
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
Sex: no restriction
Certified as requiring support or requiring long-term care
Degree of Independence in Daily Living for the Elderly with Dementia rated as independent, I, or II, with no impairment in completing the questionnaire
Provision of informed consent to participate in this study by the participant themselves (proxy consent not permitted)
Living situation stabilized, with at least 3 months elapsed since the start of service use (cross-sectional study only)
Less than 1 month elapsed since the start of new service use (longitudinal study only)
Key exclusion criteria
Difficulty understanding the questionnaire content, with no appropriate response obtainable even through interview-based administration
Presence of severe visual or auditory impairment
Requiring acute-phase medical management
Corresponding to the terminal stage of illness or receiving palliative care
Japanese not being the participant's first language
Loss of a close family member within 6 months prior to the date of survey administration
Non-consent to participation in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Goto |
Organization
Kio University
Division name
Graduate School of Health Sciences, Master's Program
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo -Cho, Kitakatsuragi-gun, Nara,635-0832, Japan
TEL
0745-54-1601
y.goto.pt@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Goto |
Organization
Kio University
Division name
Graduate School of Health Sciences, Master's Program
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo -Cho, Kitakatsuragi-gun, Nara,635-0832, Japan
TEL
0745-54-1601
Homepage URL
y.goto.pt@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Others
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
Nishiyamato Rehabilitation Hospital Research Ethics Committee
Address
3-2-2 Sasayuridai, Kamimaki-cho, Kitakatsuragi-gun, Nara 639-0218,Japan
Tel
0745-71-6688
y.goto.pt@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 | 08 | Month | 28 | 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 | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study examines the relationship between loneliness and social support among approximately 100 care-dependent older adults using day-care rehabilitation services. Because social isolation and loneliness are conceptually distinct, existing typology studies based on social isolation may fail to adequately capture this population. Accordingly, considering the characteristics of care-dependent older adults, this study adopts not social isolation-which reflects the quantitative aspect of social connectedness-but rather a combination of social support and loneliness (DJGLS), reflecting qualitative sufficiency, as the classification variables.
In the cross-sectional study, cluster analysis will be used to classify participants into subgroups, and between-group differences will be examined with respect to sex, care-need level, independence in walking, social network, psychosocial quality of life (ICECAP-O), health-related quality of life, and affiliation motivation. In the preliminary longitudinal study, assessments will be conducted at one and three months after the start of day-care use, and the relationship between longitudinal changes in loneliness and social support following the start of day-care use and psychosocial quality of life will be explored.
As an expected outcome, it is hypothesized that four subgroups will emerge based on the levels of social support and loneliness (high support/low loneliness, low support/low loneliness, high support/high loneliness, and low support/high loneliness), and differences in psychosocial characteristics and interpersonal orientation among these groups will be discussed. By developing a typology combining loneliness and social support, this study aims to provide foundational data contributing to the selection of appropriate participants for group activity support programs designed to enhance the psychosocial quality of life of care-dependent older adults.
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071767
