title: Comparing the efficacy of a web-assisted calprotectin-based treatment algorithm (IBD-live) with usual practices in teenagers with inflammatory bowel disease: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  To prevent clinical relapse in teenagers with inflammatory bowel disease (IBD) there is a need to monitor disease activity continuously. Timely optimisation of medical treatment may nip a preclinical relapse in the bud and change the natural course of IBD. Traditionally, disease monitoring is done during scheduled visits, but this is when most teenagers report full control. IBD care could be more efficient if patients were seen at times of clinical need. This study aims to examine the effectiveness of a web-assisted calprotectin-based treatment algorithm (IBD-live) compared with usual practices in teenagers with IBD.
  
  
  METHODS
  A randomized trial of web-based disease monitoring versus usual care is conducted at 10 Dutch IBD care centers. We plan to recruit 180 patients between 10- and 19-years old with quiescent IBD at baseline. Teenagers assigned to IBD-live will use the flarometer--an automatic cumulation of disease activity and fecal calprotectin measurements- to estimate probability of relapse. In case the flarometer indicates high risk the patient requires treatment intensification in accordance with national guidelines; low risk means that maintenance therapy is unchanged; and intermediate risk requires optimisation of drug adherence. Patients assigned to usual practice get the best accepted medical care with regular health checks. Primary outcome is the frequency of relapse at 52 weeks of follow-up. The diagnosis of relapse is based on a clinical activity index score >10 points necessitating remission induction therapy. Secondary outcomes include quality of life and cost-effectiveness.
  
  
  CONCLUSIONS
  Web-assisted monitoring of disease activity with rapid access for those with acute relapse may allow teenagers to develop skills that are required of adult patients (including communication and self-determination). Similar monitoring systems have been introduced for teenagers with asthma and diabetes, with a positive effect on disease control, but the intervention has not been evaluated in teenagers with IBD. A randomized trial in adult patients with ulcerative colitis showed that a web-assisted treatment algorithm is feasible, safe and cost-effective. Results of the current trial are expected to have important implications for teenagers with IBD that incurs substantial health burdens and economic costs.
  
  
  BACKGROUND
  Dutch Trial Register identifier: NTR3759 (registered 29 December 2012).
authors.affiliation: Department of Pediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, PO Box 30001, 9700, RB, Groningen, The Netherlands. a.heida01@umcg.nl.
authors.forename: Anke
authors.initials: A
authors.lastname: Heida
authors.affiliation: Department of Pediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, PO Box 30001, 9700, RB, Groningen, The Netherlands. a.dijkstra03@umcg.nl.
authors.forename: Alie
authors.initials: A
authors.lastname: Dijkstra
authors.affiliation: Department of Clinical Epidemiology (Medical Technology Assessment), University of Groningen, University Medical Centre Groningen, Hanzeplein 1, 9713, GZ, Groningen, The Netherlands. h.groen01@umcg.nl.
authors.forename: Henk
authors.initials: H
authors.lastname: Groen
authors.affiliation: Department of Laboratory Medicine, University of Groningen, University Medical Centre Groningen, Hanzeplein 1, 9713, GZ, Groningen, The Netherlands. a.c.muller@umcg.nl.
authors.forename: Anneke
authors.initials: A
authors.lastname: Muller Kobold
authors.affiliation: Department of Pediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, PO Box 30001, 9700, RB, Groningen, The Netherlands. h.j.verkade@umcg.nl.
authors.forename: Henkjan
authors.initials: H
authors.lastname: Verkade
authors.affiliation: Department of Pediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, PO Box 30001, 9700, RB, Groningen, The Netherlands. p.f.van.rheenen@umcg.nl.
authors.forename: Patrick
authors.initials: P
authors.lastname: van Rheenen
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D002648:Child; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D039841:Leukocyte L1 Antigen Complex / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D017216:Telemedicine
chemical_list: D039841:Leukocyte L1 Antigen Complex