|- candidate number||14144|
|- NTR Number||NTR3759|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-dec-2012|
|- Secondary IDs||2509 / 80-83700-98-131006 / 1301-002; Innovatiefonds / ZonMw / Fonds NutsOhra|
|- Public Title||IBD-live: Teenagers at the wheel.|
|- Scientific Title||IBD-live: Teenagers at the wheel.|
|- hypothesis||Use of IBD-live for 1 year:|
1. Reduces the relapse rate from 40% to 25%;
2. Increases quality of life (assessed with the IMPACT-III questionnaire).
|- Healt Condition(s) or Problem(s) studied||Children, Inflammatory bowel disease, Crohn's disease, Ulcerative Colitis, Self-monitoring, Calprotectin, Telemedicine , E-health|
|- Inclusion criteria||Eligible patients are those: Aged 10 to 17 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);
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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2013|
|- planned closingdate||1-jul-2016|
|- Target number of participants||180|
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 is intensified in accordance with national guidelines; low risk means that maintenance therapy is unchanged; and intermediate risk requires optimisation of drug adherence.
Usual care consists of fixed, 3-monthly contacts with the IBD-team and includes a physicians’ rating of disease activity and blood sampling.
|- Primary outcome||Primary outcome is relapse rate per group. Relapse is defined as moderate-severe disease activity in combination with fCal >500 ug/g, necessitating induction therapy.|
|- Secondary outcome||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.
|- Timepoints||Primary outcome at 12 months.|
|- Trial web site||www.ibd-live.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. P.F. Rheenen, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. P.F. Rheenen, van|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Beatrix Children's Hospital|
(Source(s) of Monetary or Material Support)
|Innovatiefonds zorgverzekeraars, ZON-MW, The Netherlands Organization for Health Research and Development, Fonds Nuts-Ohra|
|- Brief summary||N/A|
|- Main changes (audit trail)||05-Apr-2013: Changed primary outcome - NM|
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.
21-mrt-2015: change inclusion:
Old: Aged 10 to 17
New: Aged 10 to 19
Change primary outcome:
Old: Primary outcome is relapse rate per group. Relapse is defined as moderate-severe disease activity in combination with fCal >500 ug/g, necessitating induction therapy.
New: Primary outcome is time to relapse rate per group. Relapse is defined as moderate-severe disease activity in combination with fCal >250 ug/g, necessitating induction therapy.
|- RECORD||29-dec-2012 - 21-mrt-2015|