A Randomized Controlled Trial of Menopausal Tool/App for Women

June 13, 2026 updated by: Stephanie Faubion, Mayo Clinic

Evaluation of a Mobile Phone Application Tool for Menopause Symptom Management

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The tool/app, EMMII by BettrHealth
EMMII by BettrHealth Technology consists of educational components designed to enable women to more effectively identify menopause symptoms and feel confident in seeking treatment to address their symptoms
Other: EMMII
The tool/app, consists of educational components designed to enable women to more effectively identify menopause symptoms and feel confident in seeking treatment to address their symptoms. The tool/app also produces a tailored menopause discussion guide for patients to bring to their primary care appointment.
Experimental: Comparison Group/ Control Group
Patients will receive the Mayo Clinic Patient Education Pamphlet MC5544 "Perimenopause & Menopause".
Other: Comparison Group
Receive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of app logins among intervention group.
Time Frame: Up to 6 weeks
Up to 6 weeks
Compare differences in rates of menopause treatment among intervention and comparison groups.
Time Frame: Up to 6 weeks
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
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Percentage of healthcare professionals reporting 'high' & 'low' confidence in diagnosing and managing menopause symptoms
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 24-013662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To uphold the informed consent agreements with participants, which may have specified restrictions on data sharing beyond the study team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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