UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062674 |
|---|---|
| Receipt number | R000071670 |
| Scientific Title | The Relationship Between Sense of Place and Interdependent Happiness Among Older Adults Requiring Long-Term Care Who Use Day Rehabilitation Services: A Mixed-Methods Study Focusing on the Background Factors Underlying a Positive Sense of Place |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/23 22:40:59 |
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Basic information
Public title
The Relationship Between Sense of Place and Interdependent Happiness Among Older Adults Requiring Long-Term Care Who Use Day Rehabilitation Services: A Mixed-Methods Study Focusing on the Background Factors Underlying a Positive Sense of Place
Acronym
The Relationship Between Sense of Place and Interdependent Happiness Among Older Adults Requiring Long-Term Care Who Use Day Rehabilitation Services: A Mixed-Methods Study Focusing on the Background Factors Underlying a Positive Sense of Place
Scientific Title
The Relationship Between Sense of Place and Interdependent Happiness Among Older Adults Requiring Long-Term Care Who Use Day Rehabilitation Services: A Mixed-Methods Study Focusing on the Background Factors Underlying a Positive Sense of Place
Scientific Title:Acronym
The Relationship Between Sense of Place and Interdependent Happiness Among Older Adults Requiring Long-Term Care Who Use Day Rehabilitation Services: A Mixed-Methods Study Focusing on the Background Factors Underlying a Positive Sense of Place
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 clarify the association between a sense of belonging and interdependent happiness among community-dwelling older adults requiring long-term care who use day rehabilitation services.By acquiring a detailed understanding of the experiences of service users who report both a high sense of belonging and high interdependent happiness in the quantitative survey, this study seeks to exploratively clarify the background factors that lead them to perceive day rehabilitation as a 'good place to belong.'
Basic objectives2
Others
Basic objectives -Others
This study employs a quantitative survey using the Sense of Belonging Scale for Older Adults and the Interdependent Happiness Scale among older adults requiring long-term care who use day rehabilitation services, followed by a qualitative investigation to explain and elaborate, through the participants' own narratives, the background underlying high scores in these measures.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sense of Belonging Scale for Older Adults and Interdependent Happiness Scale
Key secondary outcomes
A qualitative investigation designed to provide a complementary and explanatory understanding of the factors behind high levels of sense of belonging and collaborative well-being, based on personal narratives
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.Any gender
3.Certified as requiring support or long-term care
4.Having used day rehabilitation services at the study site for more than three months, with continuous attendance as a general rule at least once a week
5.Capable of understanding the research content and responding to both the questionnaire and interview surveys
6.Having received an explanation of the study and provided written informed consent
Key exclusion criteria
1.Having a Rank III or lower status on the Degree of Independence in Daily Living for Elderly with Dementia
2.Inability to understand the research content or complete the questionnaire and interview surveys due to cognitive decline or related issues
3.Difficulty in responding to questionnaires or confirming consent-even with reasonable accommodations-due to severe aphasia, dysarthria, hearing impairment, or visual impairment
4.Deemed to experience excessive burden from participation due to acute illness, severe ill health, or psychological distress
5.Receiving palliative care for terminal illness
6.Not speaking Japanese as a first language
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Miyashita |
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
j.miyashita.2005.pt@gmail.com
Public contact
Name of contact person
| 1st name | junko |
| Middle name | |
| Last name | miyashita |
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
j.miyashita.2005.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
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
医療法人徳洲会 東大阪徳洲会病院(大阪府)
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 | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | 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 explanatory sequential mixed-methods study uses a qualitative approach to explain the narrative backgrounds of participants showing favorable sense of place and interdependent happiness in a quantitative survey.
Eligible participants are daycare rehabilitation users at the study site aged 65 or older with long-term care needs, meeting the following criteria: a dementia independence rank of None, I, or II; at least 3 months of current service use; and ability to provide personal informed consent. The Principal Investigator will conduct recruitment and consent procedures at the site, ensuring non-participants suffer no disadvantages in their care.
The study period runs from ethics committee approval through October 31, 2027. Collected data include demographic and clinical characteristics (age, sex, height, weight, primary diagnosis, psychiatric disorders, Charlson Comorbidity Index, household composition), care/service status (care level, copayment ratio, years of service use), and functional measures (dementia and disability independence ranks, walking independence, Barthel Index). Questionnaire measures comprise the Sense of Place Scale for the Elderly and the Interdependent Happiness Scale. Generally within one month post-survey, semi-structured interviews will explore the narrative backgrounds of high scorers on both scales.
The target sample size is approximately 55 for the quantitative phase and 10 to 15 for the qualitative phase.
Management information
Registered date
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071670
