A Randomized Controlled Trial of Menopausal Tool/App for Women

NCT ID: NCT06919887

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2027-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopausal Symptoms Menopause Symptom Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

EMMII

Intervention Type OTHER

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.

Comparison Group/ Control Group

Patients will receive the Mayo Clinic Patient Education Pamphlet MC5544 "Perimenopause \& Menopause".

Group Type EXPERIMENTAL

Comparison Group

Intervention Type OTHER

Receive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Comparison Group

Receive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

24 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephanie Faubion

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Karam J, Paul MM, Shufelt C, Ravikumar P, Fratianni AM, Oloyede S, Pagel EM, Hedges MS, Kapoor E, Kling JM, Cole K, Chaudhry R, Faubion SS. Evaluating the Efficacy of a Mobile Phone App in Enhancing Menopause Knowledge and Shared Decision-Making: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 8;14:e76536. doi: 10.2196/76536.

Reference Type DERIVED
PMID: 41061260 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-013662

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.