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

Quality of Life Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883073
• Other study ID #: ELEA
• Status: Completed
• Phase: N/A
• Start date: January 26, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2024
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis-related Pain
• Quality of Life

Intervention

Device:
• Use of Endo App
Use of Endo App

Locations

Country	Name	City	State
Germany	University Hospital Münster Germany	Münster	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Endo Health GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	FSS survey	Change over course of study	12 weeks
Secondary	FESS survey	Change over course of study	12 weeks
Secondary	PDI survey	Change over course of study	12 weeks
Secondary	DASS-21 survey	Change over course of study	12 weeks
Secondary	EHP 5	Change between 1st and 2nd survey	4 weeks
Secondary	EHP 5	Change between 1st and 3rd survey	8 weeks