A Randomized Controlled Trial of Menopausal Tool/App for Women

Mayo Clinic

Status: Invitation-only

Conditions: Menopausal Symptoms; Menopause Symptom Management

Treatments: Other: EMMII; Other: Comparison Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06919887

24-013662

Details and patient eligibility

About

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

Enrollment: 450 estimated patients

Sex: All

Ages: 24 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

The tool/app, EMMII by BettrHealth

Experimental group

Description:

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

Treatment:

Other: EMMII

Comparison Group/ Control Group

Experimental group

Description:

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

Treatment:

Other: Comparison Group