UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052302 |
|---|---|
| Receipt number | R000058717 |
| Scientific Title | A beore-after study on the effectiveness of the self-care application "HerLife" for menopausal symptoms |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2024/06/21 18:27:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A before-after comparison study of a novel self-care application to develop an individualized lifestyle intervention to prevent and manage menopausal symptoms
Acronym
Menopausal symptoms self-care application before-after study
Scientific Title
A beore-after study on the effectiveness of the self-care application "HerLife" for menopausal symptoms
Scientific Title:Acronym
HerLife berfore-after study
Region
| Japan |
Condition
Condition
Menopausal symptoms
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of the self-care application 'HerLife', which includes a patient-reported outcome recording function and rule-based self-care suggestions for menopausal women.
To cross-sectionally examine the association between physical characteristics and lifestyle, including nutrient deficiencies, particularly iron deficiency, and menopausal symptoms.
To develop effective personalized lifestyle interventions based on analysis using AI algorithms based on machine learning and deep learning.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity of menopausal symptoms: Modified version of the menopausal symptoms rating chart for Japanese women (26 weeks after the start of the intervention)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The subjects will download the "Her Life" smartphone app (YStory Inc. / Japan) on their own iPhone and use it for 6 months (26 weeks).
They will enter their symptoms into the app daily, and the researchers will look at the subject's symptom tracking data and measurement data for the past month and pick up the next month's health care plan from existing algorithms.
The each subject will work on improving her lifestyle based on the health care plans and enter the actual actions she has taken into the app, reading columns about health information in the app.
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Japanese women with irregular or absent menstrual cycles and menopausal symptoms
Employed (full-time, temporary, or part-time, 3 or more days per week)
The simplified menopausal index (SMI) score is between 25 and 66 points.
Own an iPhone (iOS 16 or later) and can use mobile communication daily.
Able to communicate and use apps in Japanese without any problems.
Key exclusion criteria
Those with the following comorbidities: coronary artery disease, pheochromocytoma, neurasthenia, psychiatric disorders, uncontrolled thyroid dysfunction, uncontrolled hypertension or any other comorbidity that the doctor considers unsuitable for study participation
Those who have started using new drugs (e.g. hormone replacement therapy or antidepressants) within 30 days
Those who are pregnant or lactating
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Egawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3269
megawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ohsuga |
| Middle name | |
| Last name | Takuma |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3269
Homepage URL
ohsuga@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
YStory Inc.
Name of secondary funder(s)
Ministry of Economy, Trade and Industry
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2023 | Year | 09 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 16 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058717
