Efficacy of a web-based monitoring program for teenagers with IBD Anke Heida , Anke Santema, Alie Dijkstra, Henk Groen, Patrick van Rheenen
Disclosure • This trial: Buhlmann Laboraties provided kits for measuring fecal Calprotectin • For other trials we received support from CisBio Bioassays (producer fecal marker S100A12) and Buhlmann Laboratories (producer fecal marker Calprotectin).
Telemedicine solutions are supposed to be the future Applicable? Cost-effective? Practical?
IBD-live: teenagers at the wheel
Inflammatory Bowel Disease (Crohns disease and Ulcerative Colitis)
Monitoring disease activity at pre-set timepoints
Aim Comparing the efficacy of a web-based monitoring system with usual care. Heida A et al. Trials 2015
Multicenter randomized controlled trial IBD-live headquarter Academic hospital General hospital
In- and exclusion criteria • Teenagers:10-19 years • Treatment with biologicals • IBD diagnosis > 6 months • Comorbidity requiring frequent hospital visits • Quiescent IBD > 3 months • Ileostomy or ileoanal pouch • Access to internet • Dutch language
Study endpoints AH2 • Efficacy (Time-to-relapse) • Cost-effectiveness (societal perspective) • Quality of life (IMPACT III questionnaire)
Slide 10 AH2 Quality of life en patients' experience weglaten?? A Heida, 02/06/2016
Studyflow IBD- live (n=90) 0 1 2 3 5 6 7 8 9 12 R 12 0 3 6 9 Usual care (n=90)
Flarometer
Flarometer Fecal Calprotectin PUCAI PCDAI
Interim analysis 180 Number of patients included 160 140 120 100 80 60 40 20 0 Jan ‘16 Jun ‘13
No difference in baseline characteristics IBD-live Usual care (N=53) (N=67) Age at baseline 15.3 (12.9-16.7) 15.6 (13.8-17.0) (median, IQR) Male N(%) 30 (45%) 31 (58%) Crohns disease N(%) 23 (43%) 34 (51%) Ulcerative Colitis N(%) 30 (57%) 33 (49%)
No difference in time-to-relapse IBD-live % of patients without relapse Kaplan Meijer curve • Usual care Months
IBD-live: less outpatient visits IBD-live (N=53) Usual care (n=67) No of scheduled visits 130 225 No of unscheduled visits 28 21 No of patients with unscheduled 14 (26.4%) 14 (20.9%) visit No of hospital admissions 1 3
IBD-live vs usual care No difference in time-to-relapse • Reduction of number of hospital visits •
Limitations and perspectives Interim analysis • Cost-effectiveness analysis: work in progress •
Acknowledgements IBD-live study team: Patrick van Rheenen, Alie Dijkstra, Anke • Santema, Anneke Muller Kobold, Henk Groen, Henkjan Verkade, Angelika Kindermann Participating centers: • • Funded by Supported by • Images made by Studio Ex or downloaded from freepik.com •
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