Crohn's DiseaseEDUMICILORNCT03648398
Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
A study testing EDUMICILOR in people with Crohn's Disease and Ulcerative Colitis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
EDUMICILOR is a monocentric prospective pilot study for patients with inflammatory bowel disease (IBD). During the study, patients will participate in an online therapeutic education program. They will first have an appointment with a nurse to establish a personalized educational diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- EDUMICILOR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2021to 1 Apr 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (age ≥ 18 years old)
- Patients with established Crohn's disease or ulcerative colitis diagnosis
- Patients who own the equipment to participate in the online therapeutic education program (computer, webcam….)
- French speaking patients
- Patients who cannot attend regular therapeutic education sessions at the hospital
- Patients able to understand the information provided to them and to give written informed consent for the study
Who cannot join
- Patient who has not given his/her consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
EDUMICILOR is a monocentric prospective pilot study for patients with inflammatory bowel disease (IBD).
During the study, patients will participate in an online therapeutic education program.
They will first have an appointment with a nurse to establish a personalized educational diagnosis. Then they will participate in the online therapeutic education program for about 6 months (depends on the educational needs, expectations and patient's availabilities).
The main objective of this study is to assess the feasibility of an online therapeutic education program for IBD patients.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- EDUMICILOR
- Keywords
- Therapeutic education program, Online
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDUMICILOROther
Patients will participate in the online therapeutic education program for about 6 months
| Study group | Role | What they receive |
|---|---|---|
| EDUMICILOR | Other | Patients will participate in the online therapeutic education program for about 6 months Receives: Other: EDUMICILOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of participation in the online therapeutic education program
Patients must participate in at least 80% of therapeutic education program sessions and connect to at least one video or one serious game.
Measured: 6 months
Secondary outcomes (6)
Score of the Crohn and Colitis Knowledge Score
The Crohn and Colitis Knowledge Score will assess the impact of the online therapeutic education program on achieving educational objectives.
Measured: 6 months
Score of the short Inflammatory Bowel Disease Questionnaire (short-IBDQ)
The short-IBDQ will assess the quality of life before and after the online therapeutic education program.
Measured: 6 months
Score of the Inflammatory Bowel Disease Disability Index (IBD Disability Index)
The IBD Disability index will be used to assess disability before and after the online therapeutic education program.
Measured: 6 months
Score of the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression scale will assess the anxiety and depression level before and after the online therapeutic education program.
Measured: 6 months
Score of the Girerd Scale
The Girerd Scale will be used to assess the level of adherence to prescribed drugs before and after the online therapeutic education program.
Measured: 6 months
Score of a satisfaction survey on the online therapeutic education program
This survey will identify the advantages and disadvantages of an online therapeutic education program.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start29 Jan 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muriel VELTIN, Central Hospital, Nancy, France
- Investigators
- Muriel Veltin, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648398
- Sponsor's protocol ID
- APPARA2018/EDUMICILOR-VELTIN
- Acronym
- EDUMICILOR
- Status last verified
- Mar 2021
- First submitted
- 22 Aug 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03648398
- Acronym / sponsor ID
- EDUMICILOR / APPARA2018/EDUMICILOR-VELTIN
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Therapeutic education program, Online
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 27 Aug 2018 (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.
EDUMICILOR is a monocentric prospective pilot study for patients with inflammatory bowel disease (IBD).
During the study, patients will participate in an online therapeutic education program.
They will first have an appointment with a nurse to establish a personalized educational diagnosis. Then they will participate in the online therapeutic education program for about 6 months (depends on the educational needs, expectations and patient's availabilities).
The main objective of this study is to assess the feasibility of an online therapeutic education program for IBD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDUMICILOR | Other | Other: EDUMICILORPatients will participate in the online therapeutic education program for about 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female (age ≥ 18 years old)
- Patients with established Crohn's disease or ulcerative colitis diagnosis
- Patients who own the equipment to participate in the online therapeutic education program (computer, webcam….)
- French speaking patients
- Patients who cannot attend regular therapeutic education sessions at the hospital
Key exclusion criteria (1 listed)
- Patient who has not given his/her consent to participate
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 |
|---|---|---|
| EDUMICILORPatients will participate in the online therapeutic education program for about 6 months | Other | EDUMICILOR |
Primary outcome
Frequency of participation in the online therapeutic education program
Time frame: 6 months
Patients must participate in at least 80% of therapeutic education program sessions and connect to at least one video or one serious game.
6 secondary outcomes
Score of the Crohn and Colitis Knowledge Score
Time frame: 6 months
Score of the short Inflammatory Bowel Disease Questionnaire (short-IBDQ)
Time frame: 6 months
Score of the Inflammatory Bowel Disease Disability Index (IBD Disability Index)
Time frame: 6 months
Score of the Hospital Anxiety and Depression Scale
Time frame: 6 months
Score of the Girerd Scale
Time frame: 6 months
Score of a satisfaction survey on the online therapeutic education program
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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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.
Muriel Veltin principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDUMICILOR in people with Crohn's Disease and Ulcerative Colitis, run by Central Hospital, Nancy, France at 1 site in France.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Mar 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muriel Veltin (0033383154187, muriel.veltin@micilor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of participation in the online therapeutic education program (time frame: 6 months). 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 18 Mar 2021.