Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT06912594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
App Impact on Quality of Life and Symptoms in PCOS
Sponsor:
Endo Health GmbH
Organization:
Study Overview
Official Title:
Pilot Study to Investigate the Influence of an App on the Quality of Life and Symptoms of Patients With Polycystic Ovary Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: