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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Endometriosis; Endometriosis-related Pain
• Intervention / Treatment: Device: Use of Endo App

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)

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastian D Schäfer; Phone Number: 02518344107; Email: sd.schaefer@ukmuenster.de

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48149
      • University Hospital Münster Germany
      • Contact: Sebastian D Schäfer, Dr; Phone Number: 00492518344107; Email: sd.schaefer@ukmuenster.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endo App use; use of Endo App during trial	Device: Use of Endo App; Use of Endo App
No Intervention: control; no use of Endo App during trial

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Endo Health GmbH
• Investigators: Principal Investigator: Sebastian D Schäfer, MD PhD, University Hospital Münster, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; endometriosis; Endo-App; digital therapeutics; EHP-5; Endometriosis Health Profile
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: ELEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No