A Randomized Controlled Trial of Menopausal Tool/App for Women (NCT06919887) | Clinical Trial Compass
By InvitationNot Applicable
A Randomized Controlled Trial of Menopausal Tool/App for Women
United States900 participantsStarted 2025-05-07
Plain-language 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
Who can participate
Age range
24 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For Patient Enrollment:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of app logins among intervention group.
Timeframe: Up to 6 weeks
2
Compare differences in rates of menopause treatment among intervention and comparison groups.
Timeframe: Up to 6 weeks
3
Mean score on a validated survey assessing perceived importance and availability of healthcare services for women's health conditions/concerns related to menopause
Timeframe: through study completion, an average of 1 year
4
Percentage of healthcare professionals reporting 'high' & 'low' confidence in diagnosing and managing menopause symptoms
Timeframe: through study completion, an average of 1 year