Abstract
BACKGROUND: Menopause symptoms are common but often inadequately addressed by primary care clinicians due to limited time for discussions and resources. Mobile health apps can play a crucial role in symptom identification and management; yet, many existing menopause-focused apps lack evidence-based content and medical expertise. OBJECTIVE: The aim of this study is to describe the protocol study design and methodology of a randomized controlled trial 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 randomized controlled trial 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 patients must be English-speaking, able to provide informed consent, and report a Menopause Rating Scale score ≥5, which indicates that they are experiencing significant menopause-related symptoms. Patients 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 postappointment survey sent to the patients and their primary care clinicians within 1-3 weeks of the appointment, and assessment of patient knowledge, clinical treatment plans, and both the patient and clinician 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 for 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 randomized controlled trial that aims to assess the impact of the emmii app in facilitating menopause care through primary care clinician-patient communication and shared decision-making. TRIAL REGISTRATION: ClinicalTrials.gov NCT06919887; https://clinicaltrials.gov/ct2/show/NCT06919887. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/76536.