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This study examines whether a digital app can help women manage symptoms of menopause. A total of 426 women with medically confirmed menopausal symptoms are randomly assigned to either use the app in addition to their usual medical care for 24 weeks, or to continue with usual care alone. The app provides evidence-based content and exercises for multimodal menopause management. Participants are followed up over 24 weeks, with the primary outcome assessed at 12 weeks. The main goal is to evaluate whether the app improves menopause-specific quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group has access to care-as-usual only. | |
| Intervention Group | Experimental | The intervention group has access to the menopause app and its functions in addition to care-as-usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menopause App | Device | The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a menopausal disorder, through tools such as a symptom diary and guided interactive exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause-specific quality of life | Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL) | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause-specific symptom severity | Assessed with the Menopause Rating Scale (MRS II) | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |
| Daily interference due to hot flashes |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause-specific quality of life | Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL) | Changes between time point T0 (baseline) and T4 (24 weeks after baseline) |
| Menopause-related absenteeism |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicoles | Hanover | Germany |
|
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Randomization will be stratified by the presence of concomitant treatment (non-hormonal concomitant treatment vs no concomitant treatment at baseline) to ensure balanced allocation across this prognostic factor.
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The external statistician (responsible for data analysis and/or interpretation) will be blinded to group assignment until after the analysis code for the primary analysis (ANCOVA) has been prepared and stored.
Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)
| Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |
| Menopause-specific impairment in daily activities | Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause) | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |
| Patient activation | Assessed with the Patient Activation Measure 13 (PAM-13) | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |
Assessed with the absenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
| Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |
| Menopause-related presenteeism | Assessed with the presenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause). | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |
| Menopause-related work productivity loss | Assessed with the work productivity loss domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause). | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) |