Trials / Completed
CompletedNCT04883073
Impact on Quality of Life of "Endo-App" (ELEA)
Impact on Quality of Life by Additional Use of the Digital Health Application "Endo-App" to Standard Therapy: Monocentric, Prospective, Randomised Trial (ELEA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- University Hospital Muenster · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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) 12 weeks use / no use of Endo App. Evaluation of quality of life at onset, at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. Statistical analysis of global index at the end minus global index at onset between control and intervention group.
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 weeks Endo App use). The Endo App is a german language certified medical device which can be used to monitor the disease and gives support by providing complementary, multimodal interventions to standard therapy and is commercially available. Purpose of this study is the evaluation of quality of life at onset and then at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. The secondary endpoints of this study to evaluate are Fatigue symptoms (FSSsurvey), pain- specific self-efficacy (FESS), difficulty in everyday life due to pain (PDI) and emotional wellbeing (DASS- 21)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Use of Endo App | Use of Endo App |
Timeline
- Start date
- 2023-01-26
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
- First posted
- 2021-05-12
- Last updated
- 2024-02-06
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04883073. Inclusion in this directory is not an endorsement.