UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of a mobile menstrual management app on health care and work productivity for working women
Title of the study (Brief title)	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	Hidenobu Kanaoka
Organization	docomo Healthcare, Inc.
Division name	Women's and Children's Healthcare Department
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	Tomomi Takeshima
Organization	Milliman. Inc
Division name	Japan Healthcare Practice and Data Analysis
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.tandfonline.com/doi/full/10.1080/13696998.2018.1515082
Results
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