Impact on Quality of Life of "Endo-App" (ELEA)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Endometriosis
- Endometriosis Related Pain
- Quality of Life
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: multicenter randomized controlled trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
multicenter randomized controlled trial enrolment of endometriosis patients from certified endometriosis centers 472 patients in total, 236 patients per group randomization to control group (no Endo App use) vs intervention group (Endo App use) 90 use / no use of Endo App Endo App is a german langua...
multicenter randomized controlled trial enrolment of endometriosis patients from certified endometriosis centers 472 patients in total, 236 patients per group randomization to control group (no Endo App use) vs intervention group (Endo App use) 90 use / no use of Endo App Endo App is a german language certified health application which can be used to monitor the disease and gives support by providing complementary interventions to standard therapy, it is commercially available evaluation of quality of life at onset, at 30, 60 and 90 days using endometriosis health profile (EHP) 30 summary index primary endpoint: change in EHP 30 summary index secondary endpoints: change in EHP domains pain, control and helplessness, emotional wellbeing, social support, self perception, work, sexual intercourse, treatment exploratory per protocol analysis statistical analysis of summary index at the end minus summary index at onset between control and intervention group
Tracking Information
- NCT #
- NCT04883073
- Collaborators
- Not Provided
- Investigators
- Not Provided