Status:
COMPLETED
Impact on Quality of Life of "Endo-App" (ELEA)
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Endo Health GmbH
Conditions:
Endometriosis
Endometriosis-related Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
monocentric randomized controlled trial enrolment of endometriosis patients from certified endometriosis centers. Randomization to control group (no Endo App use) vs intervention group (Endo App use) ...
Detailed Description
randomized controlled trial enrolment of patients with diagnosed endometriosis 300 patients in total, 150 patients per group, randomization to control group (no Endo App use) vs intervention group (12...
Eligibility Criteria
Inclusion
- Legal capacity
- Living in Germany
- Adequate german language skills
- Female biological gender
- Ages eligible for study ≥ 18 years
- Medical Diagnosis of endometriosis
- Diagnosis verification by following documents:
- Operation Report
- Histological finding
- MRI finding
- Other medical examination documents with endometriosis diagnosis (for example sonography, colonoscopy, cystoscopy)
- Owning a smartphone and having an internet access
- Willingness and capability of using the smartphone device and the Endo App
- Motivation to regularly fill out the questionnaries
- Owning an e-mail address for App registration
- Absence of exlusion criteria
Exclusion
- Absence of inclusion criteria
- Pregnancy existing at survey period
- Ongoing hormonal fertility treatment or planned treatment within the next 12 weeks (artificial insemination as part of in vitro fertilization, such as IVF or ICSI, hormone injections for fertility treatment)
- Ongoing or within the next 12 weeks planned rehabilitation or multimodal pain therapy
- Planned change in hormone therapy (change of active substance, new start or discontinuation of therapy) in the next 12 weeks or change in hormone therapy within the last 8 weeks before the start of the study
- Endometriosis surgery planned in the next 12 weeks or endometriosis surgery performed within the last 8 weeks prior to study start
- Previous or existing access to Endo app or current prescription
Key Trial Info
Start Date :
January 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04883073
Start Date
January 26 2023
End Date
September 1 2023
Last Update
February 6 2024
Active Locations (1)
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1
University Hospital Münster Germany
Münster, North Rhine-Westphalia, Germany, 48149