Influence of an App on Quality of Life of Women With Endometriosis (pre ELEA)

August 31, 2022 updated by: Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster

Observational Study on the Influence of an App-based Self-management Program on the Quality of Life of Women With Endometriosis

Comparison of quality of life before and after 14 days of use of Endo App® in endometriosis patients compared to non-users

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Endometriosis can significantly impair the quality of life of those affected. Multimodal self-help measures are recommended but often difficult to access. Smartphone apps have been shown to improve quality of life for other conditions with chronic pain. The aim of this study was to examine whether there is evidence of beneficial effects of the Endo-App and whether a multicenter randomized controlled trial should be planned to substantiate these effects.

Methods: In a sample of N=106 women affected by endometriosis the present study determined the influence of the use of a smartphone app (Endo-App ®) on their quality of life. Among others, the validated questionnaire Endometriosis Health Profile from Oxford University was used for this purpose.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Münster, NRW, Germany, 48149
        • University Hospital Münster Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • suffering from endometriosis
  • 18 years or older
  • willing and capable of using a smartphone

Exclusion Criteria:

  • minor under 18 years
  • endometriosis excluded
  • not capable of using a smartphone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: users
app users
Behavioral: use of Endo App®
use of Endo App® smartphone application containing endometriosis relevant exercises and educational material
No Intervention: non-users
app non-users

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life of endometriosis patients
Time Frame: 14 days
quality of life measured bei Endometriosis Health Profile 30
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pre 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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