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

Primary Purpose

Endometriosis, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
use of Endo App®
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, quality of life, smartphone application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Münster Germany

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

users

non-users

Arm Description

app users

app non-users

Outcomes

Primary Outcome Measures

quality of life of endometriosis patients
quality of life measured bei Endometriosis Health Profile 30

Secondary Outcome Measures

Full Information

First Posted
August 18, 2022
Last Updated
August 31, 2022
Sponsor
University Hospital Muenster
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1. Study Identification

Unique Protocol Identification Number
NCT05528601
Brief Title
Influence of an App on Quality of Life of Women With Endometriosis
Acronym
pre ELEA
Official Title
Observational Study on the Influence of an App-based Self-management Program on the Quality of Life of Women With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Quality of Life
Keywords
endometriosis, quality of life, smartphone application

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two arm study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
users
Arm Type
Experimental
Arm Description
app users
Arm Title
non-users
Arm Type
No Intervention
Arm Description
app non-users
Intervention Type
Behavioral
Intervention Name(s)
use of Endo App®
Intervention Description
use of Endo App® smartphone application containing endometriosis relevant exercises and educational material
Primary Outcome Measure Information:
Title
quality of life of endometriosis patients
Description
quality of life measured bei Endometriosis Health Profile 30
Time Frame
14 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
applicable for participants with female body
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Münster Germany
City
Münster
State/Province
NRW
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Influence of an App on Quality of Life of Women With Endometriosis

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