N95.1 Menopausal and Female Climacteric States
Conditions
Keywords
Menopause, Digital Therapeutics, Quality of Life
Brief summary
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.
Interventions
DEVICEMenopause App
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.
Sponsors
Endo Health GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Legal capacity * Ability to provide informed consent * Residency in Germany * Female gender * Age ≥18 years * Medically confirmed menopausal or other perimenopausal disorder (N95.1) * Ownership of a smartphone and ability to use it * Internet access for app usage and questionnaire completion * Email address for registration * Willingness to complete questionnaires online * Motivation for regular app usage * Sufficient proficiency in the German language * MRS II ≥ 9 * Absence of
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopause-specific quality of life | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) | Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menopause-specific symptom severity | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) | Assessed with the Menopause Rating Scale (MRS II) |
| Daily interference due to hot flashes | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) | Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS) |
| Menopause-specific impairment in daily activities | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) | Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause) |
| Patient activation | Changes between time point T0 (baseline) and T3 (12 weeks after baseline) | Assessed with the Patient Activation Measure 13 (PAM-13) |
Countries
Germany
Outcome results
None listed