UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051616 |
|---|---|
| Receipt number | R000058831 |
| Scientific Title | Effects of e-learning program for recovering health condition and supporting rework in female workers during parental leave: a randomized controlled trial |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2024/01/15 15:42:55 |
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Basic information
Public title
Effects of e-learning program for recovering health condition and supporting rework in female workers during parental leave: a randomized controlled trial
Acronym
Effects of e-learning program for recovering health condition and supporting rework in female workers during parental leave: RCT
Scientific Title
Effects of e-learning program for recovering health condition and supporting rework in female workers during parental leave: a randomized controlled trial
Scientific Title:Acronym
Effects of e-learning program for recovering health condition and supporting rework in female workers during parental leave: RCT
Region
| Japan |
Condition
Condition
female workers during parental leave
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of e-learning program for recovering health condition and supporting smooth rework in female workers during parental leave .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Judge by rework rates has a significant difference from pre, follow-up(at the rework) average score on web questionnaire.
Key secondary outcomes
Judge by anxiety, self efficacy of rework has a significant difference from pre, post(after 1 month) average score on web questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Five programs include postpartum care & exercise, three programs include legal information & tips of work-life balance training on e-learning. Each program takes about 15 minutes will be done during 1month again and again.
Interventions/Control_2
Five programs include postpartum care & exercise training on e-learning. Each program takes about 15 minutes will be done during 1month again and again.
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
1:female worker during parental leave
2:rearing child(ren) by oneself now
Key exclusion criteria
1 I was not able to understand Japanese questionnaire.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Watai |
Organization
Hamamatsu University School of Medicine
Division name
Community Health Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizioka Prefecture
TEL
053-435-2832
izumiw@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Watai |
Organization
Hamamatsu University School of Medicine
Division name
Community Health Nursing, Faculty of Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizioka Prefecture
TEL
053-435-2832
Homepage URL
izumiw@hama-med.ac.jp
Sponsor or person
Institute
Others
Hamamatsu university school of medicine
Institute
Department
Personal name
Izumi Watai
Funding Source
Organization
others
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Medicine, Nagoya University
School of Human Science, Sugiyama Jogakuen University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee in Hamamatsu university school of medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058831
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
