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| Name | Class |
|---|---|
| Endo Health GmbH | INDUSTRY |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endo App use | Experimental | use of Endo App during trial |
|
| control | No Intervention | no use of Endo App during trial |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Endo App | Device | Use of Endo App |
|
| Measure | Description | Time Frame |
|---|---|---|
| EHP 5 | Change in Endometriosis Health Profile 5 (minimum value: 0 points, maximum value: 100 points, higher scores mean a worse outcome) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FSS survey | Change over course of study | 12 weeks |
| FESS survey | Change over course of study | 12 weeks |
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Inclusion Criteria:
Legal capacity
Diagnosis verification by following documents:
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian D Schäfer, MD PhD | University Hospital Münster, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Münster Germany | Münster | North Rhine-Westphalia | 48149 | Germany |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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monocentric single side blinded randomized controlled trial
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| PDI survey | Change over course of study | 12 weeks |
| DASS-21 survey | Change over course of study | 12 weeks |
| EHP 5 | Change between 1st and 2nd survey | 4 weeks |
| EHP 5 | Change between 1st and 3rd survey | 8 weeks |
| D000091662 | Genital Diseases |