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

NCT ID: NCT04883073

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-26
• Study Completion Date: 2023-09-01

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)

Conditions

Endometriosis; Endometriosis-related Pain; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endo App use

use of Endo App during trial

Group Type: EXPERIMENTAL

Use of Endo App

Intervention Type: DEVICE

Use of Endo App

control

no use of Endo App during trial

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Use of Endo App

Use of Endo App

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Endo Health GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Sebastian Daniel Schäfer

Head of Department of Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian D Schäfer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Münster, Germany

Locations

University Hospital Münster Germany

Münster, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

ELEA

Identifier Type: -

Identifier Source: org_study_id