Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02550158
Other study ID # GETAID 2009-1
Secondary ID
Status Completed
Phase N/A
First received September 11, 2015
Last updated September 14, 2015
Start date June 2011
Est. completion date April 2015

Study information

Verified date September 2015
Source Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 263
Est. completion date April 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Procedure:
Educational program EDU-MICI


Locations

Country Name City State
France Chu Amiens Amiens
France Hopital Beaujon Clichy
France Hopital Louis Mourier Colombes
France Hopital Bicetre Le Kremlin-Bicetre
France CHRU Lille Lille
France Hopital Nord Marseille
France Chi Le Raincy Montfermeil Montfermeil
France Chu Montpellier Montpellier
France Chu Nantes Nantes
France CHU NICE Nice
France Hopital Saint Louis Paris
France Hopital Saint-Antoine Paris
France Institut Mutualiste Montsouris Paris
France Chu Rouen Rouen
France Chu Saint-Etienne SAINT-PRIEST en JAREZ
France Chu Toulouse Toulouse
France Hopital Tourcoing Tourcoing
France Chu Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psycho-pedagogic score (ECIPE score) Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion. 6 months after Inclusion No
Secondary Hospitalization Number of hospitalizations >24h 6 months after inclusion No
Secondary Disease Flare Number of disease flare 6 months after inclusion No
Secondary Major complication Number of major complication = number of serious adverse events related to the disease 6 months after inclusion No
Secondary Quality of life Variation of score for the Simple Inflammatory Bowel Disease Questionnaire (SIBDQ) 6 months after inclusion No
Secondary Observance Variation of score for the "Observance" questionnaire 6 months after inclusion No
Secondary Patient concerns Variation of score for the "Rating Form of Inflammatory Bowel Disease Patient Concerns" (RFIPC) questionnaire. 6 months after inclusion No
Secondary Work productivity Variation of score for the "Work Productivity and Activity Impairment - General Health" (WPAI-GH) questionnaire 6 months after inclusion No
See also
  Status Clinical Trial Phase
Recruiting NCT05702879 - Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
Not yet recruiting NCT05953402 - A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Recruiting NCT03950232 - An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03124121 - Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels Phase 4
Not yet recruiting NCT06100289 - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Phase 3
Withdrawn NCT04209556 - A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis Phase 2
Terminated NCT00061282 - Clotrimazole Enemas for Pouchitis in Children and Adults Phase 1/Phase 2
Recruiting NCT04398550 - SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis N/A
Recruiting NCT04314375 - Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis Phase 4
Active, not recruiting NCT04857112 - Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis Phase 2
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Active, not recruiting NCT04033445 - A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT05428345 - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Active, not recruiting NCT06221995 - Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Completed NCT02508012 - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases N/A
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Completed NCT03760003 - Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis Phase 2
Not yet recruiting NCT05539625 - Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis Phase 2

External Links