Crohn's disease and ulcerative colitis
Conditions
Interventions
Teenagers assigned to IBD-live will use the flarometer -an automatic cumulation
of disease activity and fecal calprotectin (fCal)- to estimate probability of
relapse. In case of high risk treatment
and
intermediate risk requires optimisation of drug adherence.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: age 10 to 19 years, quiescent IBD for more than 3 months before study enrolment, IBD diagnosed (according to the Porto criteria) more than 6 months before enrolment, access to internet and weighing scale knowledge of the Dutch language adult caregiver who is willing to actively support participation
Exclusion criteria
Exclusion criteria: maintenance treatment with infliximab or adalimumab, presence of ileostomy or ileoanal pouch, any comorbidity at the time of enrolment that requires hospitalization or frequent blood sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the frequency of relapse at 12 months of follow-up. Relapse is defined as a clinical activity score >10 points necessitating steroid therapy, a 6 week course of exclusive enteral nutrition, aminosalicylate dose escalation, or introduction of anti-TNF antibodies. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Disease specific quality of life measured with the IMPACT-III questionnaire - Cost-effectiveness will be evaluated from a societal perspective, incorporating travel expenses and costs of parental absence from work, next to direct medical costs of IBD care. | — |
Countries
Netherlands
Outcome results
None listed