UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061184 |
|---|---|
| Receipt number | R000070013 |
| Scientific Title | Development and Validation of a Protocol for Scaling Out an ICT-Enhanced Social Activity Program: Evaluation of Its Effectiveness Using a Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/07 15:25:19 |
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Basic information
Public title
Implementation and Dissemination of an ICT-Enhanced Social Activity Program: An Empirical Study
Acronym
A Dissemination Study of an ICT-Enhanced Social Activity Program
Scientific Title
Development and Validation of a Protocol for Scaling Out an ICT-Enhanced Social Activity Program: Evaluation of Its Effectiveness Using a Non-Randomized Controlled Trial
Scientific Title:Acronym
An Effectiveness Trial for the Scaling-Out of an ICT-Enhanced Social Activity Program
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a protocol for scaling out a social activity program that combines face-to-face and ICT-based interaction for frailty prevention among community-dwelling older adults. Furthermore, the study aims to verify the effectiveness and generalizability of the program implemented via this protocol through a non-randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perceptions on Community-based Connectedness with People
Key secondary outcomes
step count, walking frequency, frailty indicators, loneliness, social support, and sense of purpose in life
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
| Other |
Interventions/Control_1
[Intervention Group]
A 12-month social activity program consisting of the following two components:
Group Program: In-person sessions held once a month (15-20 minutes per session) for a total of 12 sessions.
Health Management App: Participants use "Kikoeru v2," a smartphone application developed for older adults. The app facilitates daily interaction through step-count sharing within the group and the exchange of voice messages and photos.
Interventions/Control_2
[Control Group]
Participants continue their usual activities without any specific intervention from this study.
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
1. Men and women aged 65 years or older residing in community.
2. Those capable of visiting public facilities independently.
3. Those belonging to an existing or new health-related group supported by a local government.
4. Those who understand the study's purpose and provide informed consent.
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Hirano |
Organization
Sapporo Medical University
Division name
School of Health Sciences
Zip code
060-8556
Address
S1W17, Chuo-ku, Sapporo
TEL
011-611-2111
hirano-m@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Hirano |
Organization
Sapporo Medical University
Division name
School of Health Sciences
Zip code
060-8556
Address
S1W17, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
hirano-m@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
other
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
Ethics Committee of Sapporo Medical University
Address
S1W17, Chuo-ku, Sapporo
Tel
011-611-2111
rinri@sapmed.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
| 2026 | Year | 06 | 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
| 2026 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070013
