UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060268 |
|---|---|
| Receipt number | R000068938 |
| Scientific Title | Development and Evaluation of an Educational Program Aimed at Improving Home Care Skills for Caregivers |
| Date of disclosure of the study information | 2026/01/25 |
| Last modified on | 2026/01/19 09:33:58 |
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Basic information
Public title
Development and Evaluation of an Educational Program Aimed at Improving Home Care Skills for Caregivers
Acronym
Development and Evaluation of an Educational Program Aimed at Improving Home Care Skills for Caregivers
Scientific Title
Development and Evaluation of an Educational Program Aimed at Improving Home Care Skills for Caregivers
Scientific Title:Acronym
Development and Evaluation of an Educational Program Aimed at Improving Home Care Skills for Caregivers
Region
| Japan |
Condition
Condition
Developmental dysplasia of the hip
Classification by specialty
| Pediatrics | Orthopedics | Nursing |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide video based disease prevention education to pregnant women and caregivers of newborns or infants and to examine the feasibility and preliminary effectiveness of the program by assessing changes in home care related behavior knowledge intention to practice and self efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre- and post-survey: Intent to implement healthy home care behaviors for infant hips (Period: Immediately before and after viewing prenatal educational videos)
Randomized controlled trial (follow-up survey): Frequency of healthy home care behaviors for infant hips (Period: 1 to 4 months postpartum)
Key secondary outcomes
Knowledge about healthy home care for infant hips
Self-efficacy for implementing healthy home care for hips
Subjective evaluation of program usefulness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
Online educational video (under 2 minutes) on preventing developmental dysplasia of the hip and home care
Interventions/Control_2
No treatment
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
1. Individuals who were pregnant at the time of recruitment, those raising or have raised newborns or infants up to approximately 4 months old, and their family members (including grandparents).
2. Individuals capable of reading, writing, and listening to Japanese.
3. Individuals wishing to view educational videos.
Key exclusion criteria
1. Individuals diagnosed with mental health conditions such as depression
2. Individuals raising children who have been diagnosed with hip abnormalities or dislocations
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka-Maeda |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413597
kyokoy-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | |
| Last name | Matsumoto |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358413597
Homepage URL
hiroshige-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
MEXT
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 University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 01 | Month | 25 | 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 | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2026 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068938
