Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 25, 2025
Open Peer Review Period: Apr 28, 2025 - Jun 23, 2025
Date Accepted: Sep 2, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Mobile Phone Application for Menopause Symptom Management: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Menopause symptoms are common but often inadequately addressed by primary care clinicians due to limited time for discussions and resources. Mobile health applications can play a crucial role in symptom identification and management, yet many existing menopause-focused apps lack evidence-based content and medical expertise.
Objective:
To describe the protocol study design and methodology of a randomized controlled trial (RCT) to evaluate the effectiveness of the emmii mobile app for improving menopause-related knowledge, and shared decision-making compared to a traditional menopause education pamphlet.
Methods:
This RCT will recruit women aged 45–55 years with upcoming primary care appointments at Mayo Clinic within 3 weeks of the date of initial outreach. Eligible participants must be English-speaking, able to provide informed consent, and report a Menopause Rating Scale (MRS) score ≥5, which indicates that they are experiencing significant menopause-related symptoms. Eligible participants will be randomized to have access to either the emmii app (intervention, n=200) or an evidence-based menopause education pamphlet (control, n=200). The emmii app is developed with direct input from primary care clinicians certified by The Menopause Society and offers symptom tracking, personalized treatment recommendations based on a protocol, and a discussion guide to support communication between patients and their primary care clinicians. Outcomes will include a post visit survey sent to the participants and their primary care clinicians within 3 days of the appointment, and assessment of patient knowledge, clinical treatment plans and both patients and clinicians experience. The study will also compare prescribing rates of hormonal and nonhormonal therapies for menopause symptoms between the emmii intervention and control groups to assess the app’s influence on treatment patterns. Data will be analyzed using descriptive statistics, including Chi-square tests, Wilcoxon rank sum tests and multivariable modeling.
Results:
Data collection is scheduled to begin in April 2025.
Conclusions:
This protocol outlines the design and methodology of a RCT that aims to assess the impact of the emmii app in facilitating menopause care through primary care clinician-patient communication and shared decision-making. Clinical Trial: NCT06919887
Citation
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Copyright
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