UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052530 |
|---|---|
| Receipt number | R000059943 |
| Scientific Title | A study on support for self-actualization and intergenerational exchange program for the elderly in the community |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2023/10/18 11:57:06 |
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Basic information
Public title
A study on support for self-actualization and intergenerational exchange program for the elderly in the community
Acronym
A study on support for self-actualization and intergenerational exchange program for the elderly in the community
Scientific Title
A study on support for self-actualization and intergenerational exchange program for the elderly in the community
Scientific Title:Acronym
A study on support for self-actualization and intergenerational exchange program for the elderly in the community
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects on life satisfaction and health of interventions that support purpose in life and intergenerational exchange through activities for the older adults in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Life Satisfaction Index Z
Key secondary outcomes
WHOQOL OLD
Frenchay Activities Index
Functional Reach
Time Up & Go test
Geriatric Depression Scale 15
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A total of eight sessions of two hours per session, once a month, will be held in the community.
After lectures on motivation for living and health, the elderly will discuss these issues with each other, set goals, and try to implement the program for 10 months.
Young people are also invited to participate in the class to promote intergenerational exchange.
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
Older adults living in the community aged 65 years and older.
Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria
Persons who are certified for long-term care insurance
Persons visiting the hospital for the following illnesses
Dementia, mental illness
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372405
hitmutai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372405
Homepage URL
hitmutai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2023 | Year | 10 | Month | 18 | 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
| 2023 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059943
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
