UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050322 |
|---|---|
| Receipt number | R000057303 |
| Scientific Title | Verification of the effectiveness of a web application that contributes to supports for child-rearing. |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2023/08/15 14:25:12 |
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Basic information
Public title
Verification of the effectiveness of a web application that contributes to supports for child-rearing.
Acronym
Verification of the effectiveness of a web application that contributes to supports for child-rearing.
Scientific Title
Verification of the effectiveness of a web application that contributes to supports for child-rearing.
Scientific Title:Acronym
Verification of the effectiveness of a web application that contributes to supports for child-rearing.
Region
| Japan |
Condition
Condition
Mothers with children up to 3 years of age
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the effectiveness of the web application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Parental ability to receive supports
Key secondary outcomes
self-efficacy
sense of loneliness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Providing knowledge
Interventions/Control_2
Providing knowledge
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
Female
Key inclusion criteria
Mothers with children up to 3 years of age
Key exclusion criteria
none
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Honda |
Organization
Sapporo City University
Division name
School of Nursing
Zip code
0600011
Address
Kita 11 Nsihi 13, Chuo-ku, Sapporo, Hokkaido
TEL
0117262500
h.honda@scu.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Honda |
Organization
Sapporo City University
Division name
School of Nursing
Zip code
0600011
Address
Kita 11 Nsihi 13, Chuo-ku, Sapporo, Hokkaido
TEL
0117262500
Homepage URL
h.honda@scu.ac.jp
Sponsor or person
Institute
Sapporo City University
Institute
Department
Personal name
Hikaru Honda
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Sapporo City University
Address
Geizyutunomori 1, Minami-Ku, Sapporo, Hokkaido
Tel
0115922346
kenkyu@scu.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
| 2023 | Year | 02 | Month | 13 | 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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057303
