Tokyo, Jan. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060039) titled 'A Study on the Effectiveness of a Self-Care Support Application for Menopausal Symptoms' on Jan. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kyoto university
Condition:
Condition - Menopausal symptoms
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 45
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 Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 28 Day
Anticipated trial start date - 2026 Year 01 Month 05 Day
Last follow-up date - 2027 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067727
Disclaimer: Curated by HT Syndication.
