A Randomized Controlled Trial of Menopausal Tool/App for Women

Not Applicable

• Conditions: Menopausal Symptoms; Menopause Symptom Management

• Registration Number: NCT06919887
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is about assessing the utilization of a mobile phone application (app), designed to improve the menopause experience of midlife women experiencing related symptoms and its association with menopause-related health care utilization

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-09
• Status Verified: 2025-05
• Study Start: 2025-05-07
• Last Update Submitted: 2025-05-30
• Last Update Posted: 2025-06-04
• Primary Completion: 2027-05-15
• Study Completion: 2027-12-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Women between the ages of 45 and 55
• English speaking (app only available in English)
• Able to provide informed consent
• Experiencing menopause symptoms, which will be assessed by a Menopause Rating Scale (MRS) survey score of ≥ 5
• Has an upcoming Mayo Clinic primary care appointment within 3 weeks of the enrollment and the MRS survey

Exclusion Criteria

• Lack of willingness to engage with app
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare differences in rates of menopause treatment among intervention and comparison groups.	Up to 6 weeks
Mean score on a validated survey assessing perceived importance and availability of healthcare services for women's health conditions/concerns related to menopause	through study completion, an average of 1 year
Percentage of healthcare professionals reporting 'high' & 'low' confidence in diagnosing and managing menopause symptoms	through study completion, an average of 1 year
Frequency of app logins among intervention group.	Up to 6 weeks

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States