A Randomized Controlled Trial of Menopausal Tool/App for Women

NCT06919887 | Enrolling By Invitation

• 1 other identifier: 24-013662
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Conditions

Menopausal Symptoms; Menopause Symptom Management

Outcome Measures

Primary Outcomes (4)

• Frequency of app logins among intervention group.

  Up to 6 weeks

• 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

Study Arms (2)

The tool/app, EMMII by BettrHealth

EXPERIMENTAL

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

Comparison Group/ Control Group

EXPERIMENTAL

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

Other: Comparison Group

Interventions

EMMII 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.

The tool/app, EMMII by BettrHealth

Comparison Group OTHER

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

Comparison Group/ Control Group

Eligibility Criteria

• Age: 24 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 41061260 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 9, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)