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Completed

NCT Number: NCT02550158

A Study Evaluating the Impact of an Educational Program (EDU-MICI) on Patients With Inflammatory Bowel Disease

This study has the objective to demonstrate that an education program could have a significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their disease.

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Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients 18 -70 years of age
  • Recent diagnosis (less than 6 months) of Crohn's Disease or ulcerative colitis OR patients with an oldest pathology with a new flare, a complication and / or need to optimize medical therapy

Exclusion criteria

  • Patients unable to understand and follow the program

Treatment and study plan

Educational program EDU-MICI

Procedure

Primary outcomes

  1. Psycho-pedagogic score (ECIPE score)

    Time frame: 6 months after Inclusion

    Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.

Secondary outcomes

  1. Hospitalization

    Time frame: 6 months after inclusion

    Number of hospitalizations >24h

  2. Disease Flare

    Time frame: 6 months after inclusion

    Number of disease flare

  3. Major complication

    Time frame: 6 months after inclusion

    Number of major complication = number of serious adverse events related to the disease

  4. Quality of life

    Time frame: 6 months after inclusion

    Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ)

  5. Observance

    Time frame: 6 months after inclusion

    Variation of score for the "Observance" questionnaire

  6. Patient concerns

    Time frame: 6 months after inclusion

    Variation of score for the "Rating Form of Inflammatory Bowel Disease Patient Concerns" (RFIPC) questionnaire.

  7. Work productivity

    Time frame: 6 months after inclusion

    Variation of score for the "Work Productivity and Activity Impairment - General Health" (WPAI-GH) questionnaire

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study title

A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease

Acronym: ECIPE

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Sep 15, 2015
Registry last updated
Sep 15, 2015

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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