Assistant associated optimized care of patients with IBD (Inflammatory Bowel Disease) under a biological therapy
Not Applicable
- Conditions
- K50K51Crohn disease [regional enteritis]Ulcerative colitis
- Registration Number
- DRKS00020265
- Lead Sponsor
- CED Service GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1086
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease specific quality of life measured by sIBDQ (short Inflammatory Bowel Disease Questionnaire) at baseline, 6,12 and 18 months.
- Secondary Outcome Measures
Name Time Method Secondary Outcomes will be measured at baseline, 6,12 and 18 months:<br>- restriction of participation in social life (IMET questionnaire)<br>- self-management skills (heiQ scales)<br>- satisfaction with drug therapy (SIMS-questionnaire) and adherence (MARS- questionnaire)<br>- generic health-related quality of life (EQ5D)<br>Further clinical paramters will be collected:<br>- disease activity (HBI)<br>- steroid-free remission<br>- use of glucocorticosteroids<br>- extraintestinal manifestation<br>- IBD-related surgery or hospitalization<br>- frequency of switches to biosimilars and biologic exits