UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052246 |
|---|---|
| Receipt number | R000059039 |
| Scientific Title | Effects of intergenerational exchange with university students on preventing frailty among senior residence dwellers. |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/09/14 15:21:56 |
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Basic information
Public title
Effects of intergenerational exchange with university students on preventing frailty among senior residence dwellers.
Acronym
Effects of intergenerational exchange with university students on preventing frailty among senior residence dwellers.
Scientific Title
Effects of intergenerational exchange with university students on preventing frailty among senior residence dwellers.
Scientific Title:Acronym
Effects of intergenerational exchange with university students on preventing frailty among senior residence dwellers.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to incorporate intergenerational exchanges with university students as a new method to promote social participation of elderly people who have stagnated due to the coronavirus, and to clarify the effects of psychological aspects such as improving happiness and self-efficacy in the elderly. Maintaining mental health is expected to increase social participation, eliminate isolation, and prevent frailty as a result.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using the Generativity Scale, we will assess before the intervention, 6 months after the start of the intervention, and 1 year after the start of the intervention.
Key secondary outcomes
1 POMS2 Profile of Mood States 2nd Edition
2 WHO5J
3 New General Self Efficacy NGSE
4 Frailty tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will interact with university student volunteers (nursing students) once a month for 6 months. Interventions include icebreakers, brain training, ICT utilization, reminiscence, and collaborative production for events.
Interventions/Control_2
The control group goes about their lives as usual.
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
Persons 65 years of age or older residing in the Health Promotion and Rental Senior Residence.
Key exclusion criteria
Persons who are unable to understand and answer the questionnaire.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Morita |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku Tokyo
TEL
0358035337
morita.phn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Morita |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku Tokyo
TEL
0358035337
Homepage URL
morita.phn@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nomura Real Estate Development Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University General Affairs Section School of Medicine
Address
1-5-45, Yushima, Bunkyo-ku Tokyo
Tel
0358035096
syomu1.adm@tmd.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 | 12 | Month | 01 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | 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 | 09 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059039
| Research Plan | |
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| 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 |
