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

Endo Health GmbH224 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

224

Conditions

Menopausal and Other Perimenopausal Disorders

Interventions

Menopause AppDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Endo Health GmbH

Chemnitz, Saxony, Germany

Outcomes

Primary Outcomes

Menopause-specific Quality of Life Questionnaire (MENQOL)

Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome.

Time frame: From enrollment (baseline) to the end of treatment at 12 weeks

Data from ClinicalTrials.gov

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