UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060039 |
|---|---|
| Receipt number | R000067727 |
| Scientific Title | Effectiveness of a Self-Care Support Mobile Application for Menopausal Symptoms in Midlife Women: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/12/22 22:31:32 |
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Basic information
Public title
A Study on the Effectiveness of a Self-Care Support Application for Menopausal Symptoms
Acronym
Self-Care Support App Study for Menopausal Symptoms
Scientific Title
Effectiveness of a Self-Care Support Mobile Application for Menopausal Symptoms in Midlife Women: A Randomized Controlled Trial
Scientific Title:Acronym
Self-Care Support Smartphone App for Menopausal Symptoms: RCT
Region
| Japan |
Condition
Condition
Menopausal symptoms
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the self-care support app 'JoyHer Pro' for middle-aged and older women with menopausal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of group differences in the total score of the Menopause Rating Scale (MRS) measured at baseline, 4, 8, and 12 weeks after intervention using Mixed Model for Repeated Measures (MMRM).
Key secondary outcomes
Subscales of the Menopause Rating Scale (MRS)
Simplified Menopausal Index (SMI)
Numerical Rating Scale (NRS) for symptoms such as stiff shoulders, coldness, dizziness, headache, fatigue, and weather sensitivity
Kessler 6 Psychological Distress Scale (K6)
Gastrointestinal Symptom Rating Scale (GSRS)
SF36
Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
Self Compassion Scale Short Form
Knowledge, attitudes, and coping ability related to menopause
Use of medical and health services and reasons for consultations
Global improvement assessment
Blinding status
Allocation concealment awareness
Net Promoter Score (NPS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The intervention group will use the JoyHer Pro app for 12 weeks.
Interventions/Control_2
The control group will use a limited-function app for 12 weeks.
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Japanese
Irregular menstrual cycles or absence of menstruation within the past year
Presence of any menopausal symptoms (Menopause Rating Scale [MRS] score of 5 or higher)
Ownership of an iPhone (iOS 16 or later) with daily availability of mobile data communication
Ability to communicate and use the app in Japanese without difficulty
Key exclusion criteria
Presence of the following comorbidities: coronary artery disease (such as angina or myocardial infarction), pheochromocytoma, psychiatric disorders (such as depression or schizophrenia), malignant tumors under treatment, uncontrolled thyroid dysfunction (with treatment changes within the last 3 months), or uncontrolled hypertension (with treatment changes within the last 3 months)
Started new medications (e.g., hormone replacement therapy or antidepressants) within the past 30 days.
Pregnant or breastfeeding.
Has previously used any of the following applications: JoyHer, JoyHer for Business, or JoyHer Pro.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Egawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Obstetrics and Gynecology
Zip code
606-8507
Address
54 Shogoin Kawaramachi, Sakyo-ku, Kyoto City, Japan
TEL
075-751-3284
megawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Ohsuga |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Obstetrics and Gynecology
Zip code
606-8507
Address
54 Shogoin Kawaramachi, Sakyo-ku, Kyoto City, Japan
TEL
075-751-3284
Homepage URL
whc6_adm@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
YStory Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Medical Research, Kyoto University Graduate School of Medicine and Faculty of Medicine and Kyoto University Hospital
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
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
| 2026 | Year | 01 | Month | 05 | 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
| 2025 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067727
