K50 K51
Conditions
Interventions
Group 1: Intervention group: in addition to routine medical care, IBD patients under biological therapy are cared for by a specially trained IBD assistant. Patients receive intensive care/counselling
Sponsors
CED Service GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: - crohn's disease, ulcerative colitis or colitis indeterminata according to ICD-Code - ongoing or initiating biolocial therapy at baseline - insured with Techniker Krankenkasse (TK) or cooperating health insurance companies (Mobil Krankenkasse, DAK, HEK, IKK classic, VIACTIV) - at least 18 years old - signed informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria: - steroid medication over 20 mg (except intravenous-infusion before IFX-infusion) - participation within a clinical drug study (non-interventional studies remain unaffacted) - no life-limiting/ or quality of life dominating comorbidity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease specific quality of life measured by sIBDQ (short Inflammatory Bowel Disease Questionnaire) at baseline, 6,12 and 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes will be measured at baseline, 6,12 and 18 months: - restriction of participation in social life (IMET questionnaire) - self-management skills (heiQ scales) - satisfaction with drug therapy (SIMS-questionnaire) and adherence (MARS- questionnaire) - generic health-related quality of life (EQ5D) Further clinical paramters will be collected: - disease activity (HBI) - steroid-free remission - use of glucocorticosteroids - extraintestinal manifestation - IBD-related surgery or hospitalization - frequency of switches to biosimilars and biologic exits | — |
Countries
Germany
Contacts
Public ContactEugen Urzica
CED Bio-Assist Organisationsbüro
Outcome results
None listed