Menopausal and Other Perimenopausal Disorders
Conditions
Keywords
Menopause, Digital Therapeutics, Quality of Life
Brief summary
The study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.
Interventions
DEVICEMenopause App
The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a (peri-)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)
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Legal capacity * Residency in Germany * Female sex * Age ≥18 years * Known and medically confirmed (peri-)menopausal disorder (N95.1, N95.3, N95.8, N95.9) * 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 * Absence of
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menopause-specific Quality of Life Questionnaire (MENQOL) | From enrollment (baseline) to the end of treatment at 12 weeks | Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome. |
Countries
Germany
Outcome results
None listed