Chronic Inflammatory Bowel Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Written consent of the patient (from 14 years) and parents (or the custodian) to participate in the study and the related survey and storage of data - Age of patients is at least 6 years - Chronic inflammatory bowel disease of any form (Morbus Crohn, Colitis Ulcerosa, IBDU- Inflammatory Bowel Disease Unclassified) - Knowledge of the German language required for study participation
Exclusion criteria
Exclusion criteria: - Rejection of participation by the patient or the parents (or the custodian) - Rejection of participation by the treating physician of the study centre - No fulfillment of the other inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of drug-related problems in the handling skills of long-term medications and the knowledge about this long-term medication of the respective patient patient after one year - measured by means of a observation form and a questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in PUCAI/PCDAI (Pediatric Ulcerative Colitis Activity Index/Pediatric Crohn's Disease Activity Index) depending on disease classification - Change in calprotectin - Increased adherence - Improvement of the quality of life - Number of days absent from school - Attitude towards drug therapy (acceptance) - Patient satisfaction and problems with medication - (Re)hospitalization rate - Number of discrepancies between physician's/parents' assessment on adherence to therapy and the assessment by the patient - Number of prescriptions for drugs to treat chronic inflammatory bowel disease filled at a pharmacy and the time at which the prescription was filled - these routinely documented data are collected after one year from the patient's medical record using a data collection sheet; data on quality of life are assessed by using the KINDL-questionnaire | — |
Countries
Germany
Contacts
ZAMS - Zentrum für Arzneimittelsicherheit, Universität und Universitätsklinikum Leipzig; Klinische Pharmazie, Institut für Pharmazie, Universität Leipzig