UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063138 |
|---|---|
| Receipt number | R000068978 |
| Scientific Title | A Study on the Development of an e-Learning Program for Home-Visit Support in Cases of Social Isolation |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/01 21:33:18 |
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Basic information
Public title
Development of an e-Learning Program for Home-Visit Support in Social Isolation
Acronym
E-Learning for Social Isolation
Scientific Title
A Study on the Development of an e-Learning Program for Home-Visit Support in Cases of Social Isolation
Scientific Title:Acronym
E-Learning for Social Isolation
Region
| Japan |
Condition
Condition
Social isolation such as hikikomori or non-attendance at school
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to develop an e-learning program for home-visit support providers working with socially isolated individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of visits, subjective evaluation of usefulness
Key secondary outcomes
Motivation, confidence, and perceived difficulty regarding home-visit support
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Watching four approximately 15-minute videos based on existing knowledge about support for socially isolated individuals
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Support providers assisting socially isolated individuals and belonging to organizations in Japan that implement hikikomori-specific primary services or Self-Reliance Support Programs for Needy Persons.
Key exclusion criteria
None in particular
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Funakoshi |
Organization
Kobe City College of Nursing
Division name
nursing
Zip code
651-2103
Address
3-4 Gakuennishi-machi, Nishi-ku, Kobe
TEL
078-794-8080
funakoshi@kobe-ccn.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Funakoshi |
Organization
Kobe City College of Nursing
Division name
nursing
Zip code
651-2103
Address
3-4 Gakuennishi-machi, Nishi-ku, Kobe
TEL
078-794-8080
Homepage URL
funakoshi@kobe-ccn.ac.jp
Sponsor or person
Institute
Kobe City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Research Ethics Review Committee of Kobe City College of Nursing
Address
3-4 Gakuennishi-machi, Nishi-ku, Kobe
Tel
078-794-8080
rinri@kobe-ccn.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 | 10 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://capsychnurs.jp/research/25hlinkobe/
Number of participants that the trial has enrolled
32
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
Completed
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 20 | 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 | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068978
