EndometriosisELEANCT04883073
Impact on Quality of Life of "Endo-App" (ELEA)
A study testing Use of Endo App in people with Endometriosis and Endometriosis-related Pain, run by University Hospital Muenster at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Endometriosis-related Pain, Quality of Life
- What is being tested?
- Use of Endo App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jan 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legal capacity
- Living in Germany
- Adequate german language skills
- Female biological gender
- Ages eligible for study ≥ 18 years
- Medical Diagnosis of endometriosis
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Münster Germany
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Impact on Quality of Life by Additional Use of the Digital Health Application "Endo-App" to Standard Therapy: Monocentric, Prospective, Randomised Trial (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.
Read the detailed description
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)
- Conditions
- Endometriosis, Endometriosis-related Pain, Quality of Life
- Being tested
- Use of Endo App
- Keywords
- endometriosis, quality of life, Endo-App, EHP-5, Endometriosis Health Profile, digital therapeutics
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Endo AppDevice
Use of Endo App
| Study group | Role | What they receive |
|---|---|---|
| Endo App use | Experimental | use of Endo App during trial Receives: Device: Use of Endo App |
| control | No intervention | no use of Endo App during trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
EHP 5
Change in Endometriosis Health Profile 5 (minimum value: 0 points, maximum value: 100 points, higher scores mean a worse outcome)
Measured: 12 weeks
Secondary outcomes (6)
FSS survey
Change over course of study
Measured: 12 weeks
FESS survey
Change over course of study
Measured: 12 weeks
PDI survey
Change over course of study
Measured: 12 weeks
DASS-21 survey
Change over course of study
Measured: 12 weeks
EHP 5
Change between 1st and 2nd survey
Measured: 4 weeks
EHP 5
Change between 1st and 3rd survey
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start26 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- monocentric single side blinded randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Endo Health GmbH
- Responsible party
- Principal investigator, Dr. med. Sebastian Daniel Schäfer, University Hospital Muenster
- Investigators
- Sebastian D Schäfer, MD PhD, Principal investigator, University Hospital Münster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883073
- Sponsor's protocol ID
- ELEA
- Acronym
- ELEA
- Status last verified
- Feb 2024
- First submitted
- 6 May 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Quality of Life by Additional Use of the Digital Health Application "Endo-App" to Standard Therapy: Monocentric, Prospective, Randomised Trial (ELEA)
- ClinicalTrials.gov ID
- NCT04883073
- Acronym / sponsor ID
- ELEA / ELEA
- Conditions
- Endometriosis, Endometriosis-related Pain, Quality of Life
- Keywords
- endometriosis, quality of life, Endo-App, EHP-5, Endometriosis Health Profile, digital therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Endo Health GmbH
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- monocentric single side blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Endo App use | Experimental | Device: Use of Endo Appuse of Endo App during trial |
| control | No intervention | –no use of Endo App during trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Legal capacity
- Living in Germany
- Adequate german language skills
- Female biological gender
- Ages eligible for study ≥ 18 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Endo AppUse of Endo App | Device | Endo App use |
Primary outcome
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)
6 secondary outcomes
FSS survey
Time frame: 12 weeks
FESS survey
Time frame: 12 weeks
PDI survey
Time frame: 12 weeks
DASS-21 survey
Time frame: 12 weeks
EHP 5
Time frame: 4 weeks
EHP 5
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian D Schäfer, MD PhD principal investigator
University Hospital Münster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Endo App in people with Endometriosis and Endometriosis-related Pain, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EHP 5 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.