UMIN-CTR Clinical Trial

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
Email	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
Email	nomura@mejiro.ac.jp

Sponsor
Institute	Tokyo metropolitan university Graduate School of Human Health Sciences Department of Occupational Therapy
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046264