NCT03648398

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

August 22, 2018

Last Update Submit

March 16, 2021

Conditions

Crohn's DiseaseUlcerative Colitis

Keywords

Therapeutic education programOnline

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (6)

  • Score of the Crohn and Colitis Knowledge Score

    6 months

  • Score of the short Inflammatory Bowel Disease Questionnaire (short-IBDQ)

    6 months

  • Score of the Inflammatory Bowel Disease Disability Index (IBD Disability Index)

    6 months

  • Score of the Hospital Anxiety and Depression Scale

    6 months

  • Score of the Girerd Scale

    6 months

  • +1 more secondary outcomes

Study Arms (1)

EDUMICILOR

OTHER

Patients will participate in the online therapeutic education program for about 6 months

Other: EDUMICILOR

Interventions

EDUMICILOROTHER

Patients will participate in the online therapeutic education program for about 6 months

EDUMICILOR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient who has not given his/her consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Muriel Veltin

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muriel Veltin

CONTACT

0033383154187muriel.veltin@micilor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 27, 2018

Study Start

January 29, 2021

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

FR(1)