UMIN-CTR Clinical Trial

Basic information
Public title	Development of a social activity program for frail prevention using ICT in the community
Acronym	Development of a social activity program for frail prevention using ICT in the community
Scientific Title	Development of a social activity program for frail prevention using ICT in the community
Scientific Title:Acronym	Development of a social activity program for frail prevention using ICT in the community
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to implement a social activity program for frail prevention in older men using a group social activity program and an interaction application, and to examine its effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Simple Frailty Index
Key secondary outcomes

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	Implementation of social activity programs in monthly group activities
Interventions/Control_2	Use of a smartphone with an interaction app downloaded
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	Older men who don't need assistance in activities of daily living
Key exclusion criteria	Persons receiving outpatient treatment for dementia
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Michiyo Middle name Last name Hirano
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita 12 Nishi 5, kita-ku, Sapporo, Hokkaido,Japan
TEL	011-706-3377
Email	mihirano@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Michiyo Middle name Last name Hirano
Organization	Hokkaido University
Division name	Faculty of Health Sciences
Zip code	060-0812
Address	Kita 12 Nishi 5, kita-ku, Sapporo, Hokkaido,Japan
TEL	011-706-3377
Homepage URL
Email	mihirano@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Ethics Committee of Hokkaido University
Address	Kita 12 Nishi 5, kita-ku, Sapporo, Hokkaido,Japan
Tel	011-706-3316
Email	shomu@hs.hokudai.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	2025 Year 04 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	Open public recruiting
Date of protocol fixation	2021 Year 09 Month 20 Day
Date of IRB	2021 Year 09 Month 30 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 30 Day
Last modified on	2022 Year 04 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051422