UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049586 |
|---|---|
| Receipt number | R000056478 |
| Scientific Title | Online Health Consultation to Improve the Well-Being of Working Women in the With Corona Era |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/01/08 15:25:27 |
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Basic information
Public title
A Study on Online Health Consultation to Improve the Well-Being of Working Women in the With Corona Era Pilot study
Acronym
Online Health Consultation to Improve the Well-Being of Working Women in the With Corona Era
Scientific Title
Online Health Consultation to Improve the Well-Being of Working Women in the With Corona Era
Scientific Title:Acronym
Online Health Consultation to Improve the Well-Being of Working Women
Region
| Japan |
Condition
Condition
working women
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of different methods of online health counseling (with and without the use of avatars) on the consultants (working women) and the consultees (health care providers).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
wellbeing(Evaluated immediately after completion of counseling and 28 days later)
Key secondary outcomes
Health Literacy
Quality of Communication
Satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Counseling on health issues faced by working women(Only 20 minutes per session)
Online, consultee real vs. participants real
Interventions/Control_2
Counseling on health issues faced by working women(Only 20 minutes per session)
Online, consultee avatar vs. participants avatar
Interventions/Control_3
Counseling on health issues faced by working women(Only 20 minutes per session)
Online, consultee avatar vs. participants real
Interventions/Control_4
Counseling on health issues faced by working women(Only 20 minutes per session)
Online, consultee real vs. participants avatar
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
employed, able to read and write Japanese
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | MASAYO |
| Middle name | |
| Last name | MATSUZAKI |
Organization
Osaka University
Division name
Graduate School of Medicine
Zip code
5650871
Address
1-7 Suitashi Osaka
TEL
0668792532
matsu3@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | MASAYO |
| Middle name | |
| Last name | MATSUZAKI |
Organization
Osaka University
Division name
Graduate School of Medicine
Zip code
5650871
Address
1-7 Suitashi Osaka
TEL
0668792532
Homepage URL
matsu3@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
BRING
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
BRING
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine, Osaka univeristy
Address
1-7 Suitashi Osaka
Tel
0668792532
matsu3@sahs.med.osaka-u.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
| 2022 | Year | 12 | Month | 01 | 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
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056478
| 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 |
