App Impact on Quality of Life and Symptoms in PCOS

Endo Health

Status

Not yet enrolling

Conditions

Polycystic Ovary Syndrome (PCOS)

Treatments

Device: PCOS-App

Study type

Interventional

Funder types

Industry

Identifiers

NCT06912594

RCT_PilotPCOS

Details and patient eligibility

About

This study investigates the influence of a PCOS app on the quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). The intervention group can use the app over the study period of twelve weeks in addition to care-as-usual (CAU). In the control group, this is compared with no use of the PCOS-App for a twelve-week period, that is, care-as-usual only/ continuation of the current treatment (waitlist design). The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 220 participants.

Full description

The study aims to investigate the effect of a PCOS app on quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). PCOS is a widespread and distressing health problem that can significantly affect quality of life and well-being of affected individuals. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.

The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the PCOS app over a 12-week period in addition to care-as-usual (intervention group) or only care-as-usual as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints. The primary endpoint is the Polycystic Ovary Syndrome Questionnaire (PCOSQ-G). The questionnaires/endpoints will be completed at T0 (baseline) and after 12 weeks. Statistical analyses will be conducted using R and SPSS. Exploratory evaluations of change scores in the relevant questionnaires will be performed.

Overall, this study aims to provide important insights into whether and to what extent a PCOS app can have a positive impact on the quality of life and symptoms of women with PCOS.

Enrollment

220 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Legal capacity
Resident in Germany
Female gender
Age ≥18 years up to 65 years
Diagnosed and medically confirmed Polycystic Ovary Syndrome (E28.2)
Ownership of a smartphone with a compatible iOS or Android version and the ability to operate it
Internet access and an email address for registration, app usage, and completing questionnaires
Willingness to complete questionnaires online
Motivation to use the app regularly
Sufficient knowledge of the German language

Exclusion criteria

Changes in hormone therapy within eight weeks prior to the start of the study and/or planned within the next 12 weeks
Changes in treatment with metformin within eight weeks prior to the start of the study and/or planned within the next 12 weeks
Current treatment with medications for obesity (e.g., liraglutide, orlistat)
Changes in treatment with anti-androgens (e.g., spironolactone, cyproterone acetate, flutamide) within eight weeks prior to the start of the study and/or planned within the next 12 weeks
Pregnancy or breastfeeding
Current hormonal fertility treatment
Changes in treatment with psychotropic medications within eight weeks prior to the start of the study and/or planned within the next 12 weeks
Current psychotherapeutic treatment
Previous or current access to the Endo-App or other digital health applications (DiGAs)
Current participation in other clinical studies
Current nutritional counseling according to §20 SGB V or nutritional therapy according to §43 SGB V, or participation in weight reduction programs