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

Sponsor

University Hospital Muenster (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04883073

Collaborator

(none)

472

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

multicenter 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) 90 use / no use of Endo App evaluation of quality of life at onset, at 30, 60 and 90 days using endometriosis health profile (EHP) 30 summary index statistical analysis of summary index at the end minus summary index at onset between control and intervention group

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Endometriosis-related Pain Quality of Life	Device: Use of Endo App	N/A

Detailed Description

multicenter randomized controlled trial enrolment of endometriosis patients from certified endometriosis centers 472 patients in total, 236 patients per group randomization to control group (no Endo App use) vs intervention group (Endo App use) 90 use / no use of Endo App Endo App is a german language certified health application which can be used to monitor the disease and gives support by providing complementary interventions to standard therapy, it is commercially available evaluation of quality of life at onset, at 30, 60 and 90 days using endometriosis health profile (EHP) 30 summary index primary endpoint: change in EHP 30 summary index secondary endpoints: change in EHP domains pain, control and helplessness, emotional wellbeing, social support, self perception, work, sexual intercourse, treatment exploratory per protocol analysis statistical analysis of summary index at the end minus summary index at onset between control and intervention group

Study Design

Study Type:

Interventional

Anticipated Enrollment :

472 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

multicenter randomized controlled trialmulticenter randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

EHP 30 Summary Index [90 days]
Change in Endometriosis Health Profile 30 summary index (minimum value: 0 points, maximum value: 100 points, higher scores mean a worse outcome)

Secondary Outcome Measures

EHP domains [90 days]
Change in EHP 30 domains pain, control and helplessness, emotional wellbeing, social support, self perception, work, sexual intercourse, treatment (minimum value: 0 points, maximum value: 100 points. higher scores mean a worse outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

endometriosis histologically proven
no operation or medical treatment currently performed or planned
capable of using a smartphone
willingness to use a smartphone and the Endo App

Exclusion Criteria:

absence of inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Münster Germany	Münster	NRW	Germany	48149

Sponsors and Collaborators

University Hospital Muenster

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. med. Sebastian Daniel Schäfer, Head of Department of Gynecology, University Hospital Muenster

ClinicalTrials.gov Identifier:

NCT04883073

Other Study ID Numbers:

ELEA

First Posted:

May 12, 2021

Last Update Posted:

Sep 29, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. med. Sebastian Daniel Schäfer, Head of Department of Gynecology, University Hospital Muenster

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Sep 29, 2021