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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025513
Receipt No. 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

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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
Email 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
Email tomomi.takeshima@milliman.com

Sponsor
Institute docomo Healthcare, Inc.
Institute
Department

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
Email

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
URL(English) https://upload.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


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