Influence of an App on Quality of Life of Women With Endo... | NCT05528601

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

NCT05528601

Sponsor

University Hospital Muenster

Status

Completed

Last Update Posted

Sep 6, 2022Actual

Enrollment

106Actual

Phase

Not Applicable

Conditions

Endometriosis
Quality of Life

Interventions

use of Endo App®

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jan 15, 2022Actual

Completion Date

Jan 30, 2022Actual

First Submitted Date

Aug 18, 2022

First Submission Date that Met QC Criteria

Aug 31, 2022

First Posted Date

Sep 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2022

Last Update Posted Date

Sep 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
users	Experimental	app users	Behavioral: use of Endo App®
non-users	No Intervention	app non-users

Interventions

Name	Type	Description	Arm Group Labels	Other Names
use of Endo App®	Behavioral	use of Endo App® smartphone application containing endometriosis relevant exercises and educational material	users

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

applicable for participants with female body

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Münster Germany		Münster	North Rhine-Westphalia	48149	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38869629	Derived	Rohloff N, Rothenhofer M, Gotz T, Schafer SD. Observational pilot study on the influence of an app-based self-management program on the quality of life of women with endometriosis. Arch Gynecol Obstet. 2024 Aug;310(2):1157-1170. doi: 10.1007/s00404-024-07468-4. Epub 2024 Jun 13.

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases