inflammatory bowel disease
Conditions
Interventions
Intervention:
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 ri
and intermediate risk requires optimisation of drug adherence.
Control:
Usual care consists of fixed, 3-monthly contacts with the IBD-team and includes a physicians’ rating of disease activity and b
Sponsors
Prof. dr. F. Kuipers, Dean
T: 050-3610288
University Medical Center Groningen
Beatrix Children's Hospital
Dept. Pediatric Gastroenterology
Hanzeplein 1
9713 GZ GRONINGEN
Eligibility
Inclusion criteria
Inclusion criteria: Eligible patients are those: Aged 10 to 19 years, with quiescent IBD for more than 3 months before study enrolment, with IBD diagnosed (according to the Porto criteria) more than 6 months before enrolment, who have access to internet and weighing scale, with knowledge of the Dutch language, and with an adult caregiver who is willing to actively support participation.
Exclusion criteria
Exclusion criteria: Potential participants will be excluded from the study if any of the following conditions occur: 1. Maintenance treatment with infliximab or adalimumab (for unavoidable frequent contact with health providers); 2. Presence of ileostomy or ileoanal pouch (as fCal cut-off is not validated for small bowel feces); 3. Presence of active perianal Crohn’s disease; 4. Any comorbidity at the time of enrolment that requires hospitalization or frequent blood sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is relapse rate per group. Relapse is defined as moderate-severe disease activity in combination with fCal >250 ug/g, necessitating induction therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the IMPACT-III score, which is a disease-specific quality of life score. 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. | — |
Contacts
Public ContactP.F. Rheenen, van
University Medical Center Groningen Beatrix Children's Hospital Dept. Pediatric Gastroenterology Hanzeplein 1
Outcome results
None listed