IBD-live: Teenagers at the wheel.
Completed
- Conditions
- inflammatory bowel diseaserelapseCrohn’s diseaseulcerative colitiseHealthtelemedicinechildrencalprotectinhome monitoring
- Registration Number
- NL-OMON29580
- Lead Sponsor
- Prof. dr. F. Kuipers, DeanT: 050-3610288University Medical Center GroningenBeatrix Children's HospitalDept. Pediatric GastroenterologyHanzeplein 19713 GZ GRONINGE
- Brief Summary
https://doi.org/10.1186/s13063-015-0787-x https://doi.org/10.1093/ecco-jcc/jjx169
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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
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);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary endpoints include the IMPACT-III score, which is a disease-specific quality of life score.<br /><br>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.