UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040535 |
|---|---|
| Receipt number | R000046264 |
| Scientific Title | A study on the development of a community exchange program for elderly males |
| Date of disclosure of the study information | 2020/05/30 |
| Last modified on | 2022/11/28 14:08:32 |
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Basic information
Public title
A study on the development of a community exchange program for elderly males
Acronym
A study on the development of a community exchange program for elderly males
Scientific Title
A study on the development of a community exchange program for elderly males
Scientific Title:Acronym
A study on the development of a community exchange program for elderly males
Region
| Japan |
Condition
Condition
Frailty, Geriatric syndrome
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to preliminarily examine the effect of a program that encourages participation in social activities as a measure for social isolation of elderly males.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Social Activities Related Daily Life Satisfaction for the Elderly(Initial program, final program (at the beginning of the program, at the end of the program (after 3 months), and at 3 and 6 months after the end of the program)
Key secondary outcomes
Index of Social Interaction,Self-completed Occupational Performance Index, the Kihon Checklist(Initial program, final program (at the beginning of the program, at the end of the program (after 3 months), and at 3 and 6 months after the end of the program)
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The subjects reflect on their own social activities with others and identify individual issues related to their social activities. Subjects learn about local social resources and how to solve problems, and then gain experience in changing their own social activities. The program consists of 120 minutes once a week for a total of 12 sessions. Each session consists of lectures, exercises or experiences, and homework is given as needed. The exercises is mainly to fill in the teaching materials and discuss about the themes.
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
Key inclusion criteria
Elderly males who are able to come to the venue where the program is held.
Key exclusion criteria
Elderly males who are hospitalized or entered in facilities and those who have difficulty communicating.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Nomura |
Organization
Mejiro University
Division name
Department of Occupational Therapy Faculty of Health Sciences
Zip code
339-8501
Address
320 Ukiya,Iwatsuki-ku Saitama-shi Saitama
TEL
048-797-2131
nomura@mejiro.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Nomura |
Organization
Mejiro University
Division name
Department of Occupational Therapy Faculty of Health Sciences
Zip code
339-8501
Address
320 Ukiya,Iwatsuki-ku Saitama-shi Saitama
TEL
048-797-2131
Homepage URL
nomura@mejiro.ac.jp
Sponsor or person
Institute
Tokyo metropolitan university
Graduate School of Human Health Sciences
Department of Occupational Therapy
Institute
Department
Personal name
Funding Source
Organization
Mejiro 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
the IRB at Tokyo Metropolitan University, Arakawa Campus
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
rinri-hs@tmu.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
| 2020 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
This program led to significant improvement in independent living and interest in society, but it did not help increase satisfaction with social activities. Additionally, a qualitative data identify that this program encouraged subjects to proactivity participate in social activities.
Results date posted
| 2021 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 23 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046264
