A Randomized Controlled Trial of Menopausal Tool/App for Women
NCT ID: NCT06919887
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
450 participants
INTERVENTIONAL
2025-05-07
2027-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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.
Comparison Group/ Control Group
Patients will receive the Mayo Clinic Patient Education Pamphlet MC5544 "Perimenopause \& Menopause".
Comparison Group
Receive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options.
Interventions
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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.
Comparison Group
Receive educational menopause pamphlet describing menopause symptoms and evidence-based treatment options.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to provide informed consent
24 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Stephanie Faubion
Principal Investigator
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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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.
Other Identifiers
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24-013662
Identifier Type: -
Identifier Source: org_study_id
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