NCT05528601

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
Last Updated

September 6, 2022

Status Verified

August 1, 2022

Enrollment Period

14 days

First QC Date

August 18, 2022

Last Update Submit

August 31, 2022

Conditions

EndometriosisQuality of Life

Keywords

endometriosisquality of lifesmartphone application

Outcome Measures

Primary Outcomes (1)

  • quality of life of endometriosis patients

    quality of life measured bei Endometriosis Health Profile 30

    14 days

Study Arms (2)

users

EXPERIMENTAL

app users

Behavioral: use of Endo App®

non-users

NO INTERVENTION

app non-users

Interventions

use of Endo App®BEHAVIORAL

use of Endo App® smartphone application containing endometriosis relevant exercises and educational material

users

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsapplicable for participants with female body
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Münster Germany

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (1)

  • 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.

    PMID: 38869629DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two arm study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 18, 2022

First Posted

September 6, 2022

Study Start

January 1, 2022

Primary Completion

January 15, 2022

Study Completion

January 30, 2022

Last Updated

September 6, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)