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Completed

NCT Number: NCT04883073

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

monocentric 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) 12 weeks use / no use of Endo App. Evaluation of quality of life at onset, at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. Statistical analysis of global index at the end minus global index at onset between control and intervention group.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Münster Germany

Münster, North Rhine-Westphalia, 48149, Germany

About this study

randomized controlled trial enrolment of patients with diagnosed endometriosis 300 patients in total, 150 patients per group, randomization to control group (no Endo App use) vs intervention group (12 weeks Endo App use). The Endo App is a german language certified medical device which can be used to monitor the disease and gives support by providing complementary, multimodal interventions to standard therapy and is commercially available. Purpose of this study is the evaluation of quality of life at onset and then at 4, 8 and 12 weeks by using endometriosis health profile (EHP) 5 as a global index. The secondary endpoints of this study to evaluate are Fatigue symptoms (FSSsurvey), pain- specific self-efficacy (FESS), difficulty in everyday life due to pain (PDI) and emotional wellbeing (DASS- 21)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Legal capacity

  • Living in Germany
  • Adequate german language skills
  • Female biological gender
  • Ages eligible for study ≥ 18 years
  • Medical Diagnosis of endometriosis

Diagnosis verification by following documents:

  • Operation Report
  • Histological finding
  • MRI finding
  • Other medical examination documents with endometriosis diagnosis (for example sonography, colonoscopy, cystoscopy)

Owning a smartphone and having an internet access

Willingness and capability of using the smartphone device and the Endo App

Motivation to regularly fill out the questionnaries

Owning an e-mail address for App registration

Absence of exlusion criteria

Exclusion criteria

  • Absence of inclusion criteria
  • Pregnancy existing at survey period
  • Ongoing hormonal fertility treatment or planned treatment within the next 12 weeks (artificial insemination as part of in vitro fertilization, such as IVF or ICSI, hormone injections for fertility treatment)
  • Ongoing or within the next 12 weeks planned rehabilitation or multimodal pain therapy
  • Planned change in hormone therapy (change of active substance, new start or discontinuation of therapy) in the next 12 weeks or change in hormone therapy within the last 8 weeks before the start of the study
  • Endometriosis surgery planned in the next 12 weeks or endometriosis surgery performed within the last 8 weeks prior to study start
  • Previous or existing access to Endo app or current prescription

Treatment and study plan

Use of Endo App

Device

Use of Endo App

Primary outcomes

  1. EHP 5

    Time frame: 12 weeks

    Change in Endometriosis Health Profile 5 (minimum value: 0 points, maximum value: 100 points, higher scores mean a worse outcome)

Secondary outcomes

  1. FSS survey

    Time frame: 12 weeks

    Change over course of study

  2. FESS survey

    Time frame: 12 weeks

    Change over course of study

  3. PDI survey

    Time frame: 12 weeks

    Change over course of study

  4. DASS-21 survey

    Time frame: 12 weeks

    Change over course of study

  5. EHP 5

    Time frame: 4 weeks

    Change between 1st and 2nd survey

  6. EHP 5

    Time frame: 8 weeks

    Change between 1st and 3rd survey

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Endo Health GmbH

Registry information

Official study title

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

Acronym: ELEA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 12, 2021
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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