Trial Details

Not Recruiting
Basic Information
Clinical ID c2689
Identifier DRKS00015505
Trial Title Cluster randomized trial to investigate register-based feedback to clinicians and improve care for pediatric patients with inflammatory bowel disease - CLARA
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions K50 K51;Crohn disease [regional enteritis];Ulcerative colitis
Interventions Group 1: Intervention group: Participating children's gastroenterological centers of the intervention group receive an online access to the CEDATA-GPGE patient registry from the Study Center in Gien. The gastroenterological centers document the diagnostic and treatment parameters of patients under the age of 18 who have a diagnosed, chronic inflammatory bowel disease and who treat them for the first time in their outpatient clinic. In the further course of treatment, every visit of the patients in the outpatient clinic should be documented in the register. The first report and two reports within 12 months from the patients inclusion are obligatory. After each documentation in the CEDATA-GPGE, the physicians of the intervention group receives patient-specific feedback on possible care deficits in their treatment and get recommendations, which come from automated algorithms. Group 2: Control group: Inclusion criterions are the same like in the intervention group. Patients be will also included in the control group, that are treated for the first time in one of the participating outpatient clinics and which are under the age of 18 years. The ambulances of the control group do not document diagnostic and treatment data in the patient register CEDATA-GPGE. They just continue their usual documentation. They will not receive any feedback and treatment recommendations. After the observation period, the diagnostic and treatment data will be retrieved retrospectively out of the patient records by a study team and transferred to the register CEDATA-GPGE. At the end of the observation period, the centers of the control group can report themselves in the register if tehy want to.
Participant Information
Sponsor Zentrum f Kinder- und Jugendheilkunde, Abt. Allgemeine Piatrie und NeonatalogieJustus-Liebig-Universit Greifswald
City -
Country/Region Germany
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2022-06-30