App Impact on Quality of Life and Symptoms in PCOS

NCT06912594 | Not Yet Recruiting

• 1 other identifier: RCT_PilotPCOS
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

PCOS; Quality of Life; Digital Therapeutics

Outcome Measures

Primary Outcomes (1)

• Polycystic Ovary Syndrome Questionnaire (PCOSQ-G)

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (3)

• Body Appreciation Scale - 2 (BAS-2)

  From enrollment to the end of treatment at 12 weeks

• Patient Activation Measure 13 (PAM-13)

  From enrollment to the end of treatment at 12 weeks

• Depression Anxiety Stress Scale 21 Items (DASS-21)

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Control group has access to care-as-usual only.

Intervention Group

EXPERIMENTAL

The intervention group has access to the PCOS app and its functions in in addition to care-as-usual

Device: PCOS-App

Interventions

PCOS-App DEVICE

The PCOS-App helps to implement multimodal self-help measures in the daily lives of PCOS patients through various functions such as symptom diary and interactive exercises.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Health GmbH: lead

Study Sites (1)

Endo Health GmbH

Chemnitz, Saxony, 09111, Germany

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Teresa Götz, M.Sc.

CONTACT

+49 371 33560304; teresa@endometriose.app

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 6, 2025
• Study Start: April 2, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)