Clinical trial NCT04883073: Impact on Quality of Life of "Endo-App" (ELEA)
Official title: Impact on Quality of Life by Additional Use of the Digital Health Application "Endo-App" to Standard Therapy: Monocentric, Prospective, Randomised Trial (ELEA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Endometriosis-related Pain
Quality of Life
Keywords: endometriosis
quality of life
Endo-App
EHP-5
Endometriosis Health Profile
digital therapeutics
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Endo Health GmbH
First posted: 2021-05-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocentric single side blinded randomized controlled trial
Primary purpose: TREATMENT

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) 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)

Eligibility criteria: 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:

1. Operation Report
2. Histological finding
3. MRI finding
4. 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

Primary outcomes:
measure: EHP 5
timeFrame: 12 weeks
Secondary outcomes:
measure: FSS survey
timeFrame: 12 weeks
measure: FESS survey
timeFrame: 12 weeks
measure: PDI survey
timeFrame: 12 weeks
measure: DASS-21 survey
timeFrame: 12 weeks
measure: EHP 5
timeFrame: 4 weeks
measure: EHP 5
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Münster Germany
state: NRW
Study officials:
affiliation: University Hospital Münster, Germany
name: Sebastian D Schäfer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: