Evaluation of a Mobile Menopause Application
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEndo Health GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Legal capacity
Ability to provide informed consent
Residency in Germany
Female gender
Disqualifiers
Pregnancy or breastfeeding during the study period
Current hormonal replacement therapy (HRT), initiation of HRT within eight weeks prior to study start and/or planned start of HRT during the study period
Changes in treatment with psychotropic medication within eight weeks prior to study start and/or planned during the study period
Start of psychotherapy within eight weeks prior to study start and/or planned during the study period
Trial design
Design model
Parallel
Treatments tested in this trial
Menopause App
DeviceThe 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.
Treatment groups
426 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Menopause-specific quality of life
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)Secondary outcomes
1
Menopause-specific symptom severity
Assessed with the Menopause Rating Scale (MRS II)
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)2
Daily interference due to hot flashes
Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)3
Menopause-specific impairment in daily activities
Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause)
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)4
Patient activation
Assessed with the Patient Activation Measure 13 (PAM-13)
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)Other outcomes
1
Menopause-specific quality of life
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
Time frame
Changes between time point T0 (baseline) and T4 (24 weeks after baseline)2
Menopause-related absenteeism
Assessed with the absenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)3
Menopause-related presenteeism
Assessed with the presenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)4
Menopause-related work productivity loss
Assessed with the work productivity loss domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Time frame
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: