UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025513 |
|---|---|
| Receipt number | R000029325 |
| Scientific Title | Effectiveness of a mobile menstrual management app on health care and work productivity for working women |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2018/11/20 15:00:16 |
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Basic information
Public title
Effectiveness of a mobile menstrual management app on health care and work productivity for working women
Acronym
Effectiveness of a mobile menstrual management app for working women
Scientific Title
Effectiveness of a mobile menstrual management app on health care and work productivity for working women
Scientific Title:Acronym
Effectiveness of a mobile menstrual management app for working women
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of a mobile menstrual management app on preventing diseases and work productivity impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Work productivity (WPAI score), incidence of diseases (related to menstrual period and depression), depression (PHQ-9 score) at baseline, 1, 2, and 3 months from start.
Key secondary outcomes
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use of a mobile menstrual management app (for 3 months)
Interventions/Control_2
No intervention
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Aged between 20 and 45.
2) Selected as full-time worker, and one of the following answers: office worker, company executive, public servant, self-employment, professional, or temporary employee/contract worker.
3) Answered as non-pregnant.
4) Had never downloaded the app used in the trial nor applied for membership of the app.
5) Smartphone user.
Key exclusion criteria
1) Aged less than 20 or more than 46.
2) Selected as one of the following answers: part-time worker, student, housewife, or others.
3) Not full-time worker.
4) Answered as pregnant.
5) Had downloaded the app used in the trial or applied for membership of the app.
6) Not smartphone user.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenobu Kanaoka |
Organization
docomo Healthcare, Inc.
Division name
Women's and Children's Healthcare Department
Zip code
Address
Ebisu Business Tower 4F 1-19-19, Ebisu, Shibuya-ku, Tokyo, Japan
TEL
03-6721-7529
hidenobu.kanaoka.hk@d-healthcare.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomi Takeshima |
Organization
Milliman. Inc
Division name
Japan Healthcare Practice and Data Analysis
Zip code
Address
ACN Hanzomon Building 12F, 2-2-22 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-5211-7031
Homepage URL
tomomi.takeshima@milliman.com
Sponsor or person
Institute
docomo Healthcare, Inc.
Institute
Department
Personal name
Funding Source
Organization
docomo Healthcare, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Anterio Inc., Intage Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/13696998.2018.1515082
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
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2018 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029325
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
