Impact on Quality of Life of Endo-App (ELEA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Impact on Quality of Life by Additional Use of the Digital Health Application Endo-App to Standard Therapy: Monocentric, Prospective, Randomised Trial (ELEA)

Conditions
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Endometriosis, Endometriosis-related Pain, Quality of Life

Intervention / Treatment
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* Device: Use of Endo App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: monocentric single side blinded randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endo App use<br>use of Endo App during trial | Device: Use of Endo App<br>* Use of Endo App<br>|
| No Intervention: control<br>no use of Endo App during trial | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSS survey | Change over course of study | 12 weeks | 
| FESS survey | Change over course of study | 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EHP-5, Endometriosis Health Profile, digital therapeutics, endometriosis, quality of life, Endo-App