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IBD-live: Teenagers at the wheel.


- candidate number14144
- NTR NumberNTR3759
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-dec-2012
- Secondary IDs2509 / 80-83700-98-131006 / 1301-002; Innovatiefonds / ZonMw / Fonds NutsOhra
- Public TitleIBD-live: Teenagers at the wheel.
- Scientific TitleIBD-live: Teenagers at the wheel.
- ACRONYM
- hypothesisUse 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) studiedChildren, Inflammatory bowel disease, Crohn's disease, Ulcerative Colitis, Self-monitoring, Calprotectin, Telemedicine , E-health
- Inclusion criteriaEligible 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 criteriaPotential 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2013
- planned closingdate1-jun-2015
- Target number of participants304
- InterventionsIntervention:
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.

Control:
Usual care consists of fixed, 3-monthly contacts with the IBD-team and includes a physicians’ rating of disease activity and blood sampling.
- Primary outcomePrimary 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 outcomeSecondary 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.
- TimepointsPrimary outcome at 12 months.
- Trial web sitewww.ibd-live.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. P.F. Rheenen, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. P.F. Rheenen, van
- Sponsor/Initiator University Medical Center Groningen (UMCG), Beatrix Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Innovatiefonds zorgverzekeraars, ZON-MW, The Netherlands Organization for Health Research and Development, Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryN/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.
- RECORD29-dec-2012 - 7-jun-2013


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