Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause

Endo Health

Status

Completed

Conditions

Menopausal and Other Perimenopausal Disorders

Treatments

Device: Menopause App

Study type

Interventional

Funder types

Industry

Identifiers

NCT06987617

RCT_PilotMeno

Details and patient eligibility

About

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.

Enrollment

224 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 exclusion criteria

Exclusion criteria

Changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks
Changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks
Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
Current participation in other clinical studies
Failure to meet the inclusion criteria