Individualized home-monitoring of disease activity in adult patients with inflammatory bowel disease can be recommended in clinical practice: A randomized-clinical trial

World J Gastroenterol. 2019 Oct 28;25(40):6158-6171. doi: 10.3748/wjg.v25.i40.6158.

Abstract

Background: The optimal way to home-monitor patients with inflammatory bowel disease (IBD) for disease progression or relapse remains to be found.

Aim: To determine whether an electronic health (eHealth) screening procedure for disease activity in IBD should be implemented in clinical practice, scheduled every third month (3M) or according to patient own decision, on demand (OD).

Methods: Adult IBD patients were consecutively randomized to 1-year open-label eHealth interventions (3M vs OD). Both intervention arms were screening for disease activity, quality of life and fatigue and were measuring medical compliance with the constant care web-application according to the screening interventions OD or 3M. Disease activity was assessed using home measured fecal calprotectin (FC) and a disease activity score.

Results: In total, 102 patients were randomized (n = 52/50 3M/OD) at baseline, and 88 patients completed the 1-year study (n = 43 3M; n = 45 OD). No difference in the two screening procedures could be found regarding medical compliance (P = 0.58), fatigue (P = 0.86), quality of life (P = 0.17), mean time spent in remission (P > 0.32), overall FC relapse rates (P = 0.49), FC disease courses (P = 0.61), FC time to a severe relapse (P = 0.69) and remission (P = 0.88) during 1 year. Median (interquartile range) numbers of FC home-monitoring test-kits used per patient were significantly different, 3M: 6.0 (5.0-8.0) and OD: 4.0 (2.0-9.0), P = 0.04.

Conclusion: The two eHealth screening procedures are equally good in capturing a relapse and bringing about remission. However, the OD group used fewer FC home test-kits per patient. Individualized screening procedures can be recommended for adult IBD patients in clinical web-practice.

Keywords: Disease activity; Electronic health; Inflammatory bowel disease; Screening.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Biological Products / therapeutic use
  • Colitis, Ulcerative / diagnosis*
  • Colitis, Ulcerative / drug therapy
  • Crohn Disease / diagnosis*
  • Crohn Disease / drug therapy
  • Disease Progression
  • Feces / chemistry
  • Female
  • Glucocorticoids / therapeutic use
  • Humans
  • Immunologic Factors / therapeutic use
  • Internet-Based Intervention*
  • Leukocyte L1 Antigen Complex / analysis
  • Male
  • Mass Screening / instrumentation
  • Mass Screening / methods*
  • Medication Adherence
  • Middle Aged
  • Program Evaluation
  • Quality of Life
  • Recurrence
  • Severity of Illness Index
  • Telemedicine / instrumentation
  • Telemedicine / methods*

Substances

  • Biological Products
  • Glucocorticoids
  • Immunologic Factors
  • Leukocyte L1 Antigen Complex