UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062662 |
|---|---|
| Receipt number | R000071732 |
| Scientific Title | Development and Evaluation of an Infant Injury Prevention Education Program for Grandparents |
| Date of disclosure of the study information | 2026/08/23 |
| Last modified on | 2026/08/23 20:19:50 |
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Basic information
Public title
Development and Evaluation of an Infant Injury Prevention Education Program for Grandparents
Acronym
Development and Evaluation of an Infant Injury Prevention Education Program for Grandparents
Scientific Title
Development and Evaluation of an Infant Injury Prevention Education Program for Grandparents
Scientific Title:Acronym
Development and Evaluation of an Infant Injury Prevention Education Program for Grandparents
Region
| Japan |
Condition
Condition
Infant Injury
Classification by specialty
| Pediatrics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to (1) clarify grandparents' knowledge, beliefs and attitudes, and preventive behaviors regarding injury prevention, and (2) develop an injury prevention education program for grandparents and evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Injury prevention behaviors
Key secondary outcomes
(1)Knowledge, intention to engage in preventive behaviors, and attitudes regarding injury prevention
(2) Generativity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Injury prevention education program developed in this study
Interventions/Control_2
Usual educational materials on infant injury prevention
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Approximately 50 to 79 years of age.
Individuals who may have opportunities to care for grandchildren or children of relatives or neighbors, who are physically and mentally healthy, and who are able to participate in interviews or the program independently.
Key exclusion criteria
Those who do not meet the inclusion criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Nishida |
Organization
Institute of Science Tokyo
Division name
School of Engineering
Zip code
1528550
Address
2-12-1 Ookayama, Meguro-ku, Tokyo
TEL
03-5734-3653
nishida.y.af@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Chikako |
| Middle name | |
| Last name | Honda |
Organization
Institute of Science Tokyo
Division name
School of Engineering
Zip code
152-0031
Address
2-12-1 Ookayama, Meguro-ku, Tokyo
TEL
03-5734-3653
Homepage URL
honda.c.2f72@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
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
Institute of Science Tokyo
Address
2-12-1 Ookayama, Meguro-ku, Tokyo
Tel
03-5734-3808
human.ethics.comm-oo@adm.isct.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 | 08 | Month | 23 | 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
| 2027 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2027 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 08 | Month | 23 | Day |
Last modified on
| 2026 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071732
