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

NCT04883073 | Completed

• 1 other identifier: ELEA
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Endometriosis-related Pain; Quality of Life

Keywords

endometriosis; quality of life; Endo-App; EHP-5; Endometriosis Health Profile; digital therapeutics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• FSS survey

  12 weeks

• FESS survey

  12 weeks

• PDI survey

  12 weeks

• DASS-21 survey

  12 weeks

• EHP 5

  4 weeks

Study Arms (2)

Endo App use

EXPERIMENTAL

use of Endo App during trial

Device: Use of Endo App

control

NO INTERVENTION

no use of Endo App during trial

Interventions

Use of Endo App DEVICE

Use of Endo App

Endo App use

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Endo Health GmbH: collaborator

Study Sites (1)

University Hospital Münster Germany

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sebastian D Schäfer, MD PhD

  University Hospital Münster, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Gynecology

Model Details: monocentric single side blinded randomized controlled trial

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: January 26, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)