Effectiveness of a Personalized Self-Care Smartphone Application for Menopausal Symptoms in Midlife Women: Randomized Controlled Trial (Preprint)

BACKGROUND Menopausal symptoms can substantially affect the health and daily lives of midlife women, yet many women do not seek or receive adequate support. Smartphone-based interventions may provide an accessible approach to supporting women with menopausal symptoms, but randomized evidence for personalized, self-directed interventions remains limited. OBJECTIVE This study aimed to evaluate the effectiveness of JoyHer Pro, a personalized self-care smartphone application, in reducing menopausal symptoms among midlife women. METHODS We conducted a fully remote, 12-week, two-arm, parallel-group randomized controlled trial in Japan. Women aged 45 to <60 years with irregular or absent menstruation and a Menopause Rating Scale (MRS) total score of ≥5 were recruited online and randomly assigned 1:1 to the intervention or control group using permuted-block randomization stratified by screening MRS score (<9 vs ≥9). Both groups received access to the same 58 educational topics, with the recommended content order personalized according to symptoms selected at registration. The intervention group additionally had access to daily self-monitoring, algorithmically personalized self-care advice (“Tips”) updated every 2 weeks without individualized input from clinicians or researchers, and daily notifications. The primary outcome was the self-reported MRS total score at week 12, analyzed using a mixed model for repeated measures. The prespecified full analysis set comprised randomized participants who downloaded the assigned application and completed the baseline questionnaire. RESULTS Of 584 randomized participants, 401 were included in the full analysis set (intervention, n=197; control, n=204). At week 12, the adjusted mean MRS total score was 10.29 (95% CI 9.64-10.95) in the intervention group and 11.98 (95% CI 11.34-12.61) in the control group, with an adjusted between-group difference of −1.68 points (95% CI −2.59 to −0.77; P<.001). Differences favoring the intervention were also observed at weeks 4 and 8. Exploratory analyses showed lower somatic, psychological, and urogenital MRS subscale scores in the intervention group at week 12. In a post hoc responder analysis, 42.1% (72/171) of participants in the intervention group and 26.9% (49/182) in the control group achieved a ≥5-point reduction in MRS total score at week 12 (risk difference 15.2 percentage points; relative risk 1.56). The median number of application login days was 16 in the intervention group and 5 in the control group. No intervention-related adverse events were spontaneously reported. CONCLUSIONS In this randomized controlled trial, a 12-week personalized self-care smartphone intervention produced a greater reduction in menopausal symptoms than a limited-function educational control application providing the same educational content with baseline symptom-based personalization. These findings support the potential of a fully self-directed smartphone intervention integrating longitudinal symptom self-monitoring with self-care support repeatedly personalized based on accumulated user data to help women manage menopausal symptoms in daily life. CLINICALTRIAL UMIN Clinical Trials Registry: UMIN000060039; https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067727