Randomized Clinical Trial
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 28, 2019; 25(40): 6158-6171
Published online Oct 28, 2019. doi: 10.3748/wjg.v25.i40.6158
Individualized home-monitoring of disease activity in adult patients with inflammatory bowel disease can be recommended in clinical practice: A randomized-clinical trial
Dorit Vedel Ankersen, Petra Weimers, Dorte Marker, Mette Bennedsen, Sanaz Saboori, Kristine Paridaens, Johan Burisch, Pia Munkholm
Dorit Vedel Ankersen, Petra Weimers, Dorte Marker, Mette Bennedsen, Sanaz Saboori, Johan Burisch, Pia Munkholm, Department of Gastroenterology, North Zealand University Hospital, Frederikssund 3600, Capital region, Denmark
Kristine Paridaens, Global Medical Affairs, Ferring International Center S.A., Saint-Prex 1162, Switzerland
Author contributions: Ankersen DV prepared the manuscript, which was critically reviewed by all co-authors; Ankersen DV, Marker D, Burisch J and Munkholm P designed the study; Marker D, Bennedsen M and Munkholm P conducted the study; Ankersen DV had full access to data in the study and takes full responsibility for their integrity; Ankersen DV, Marker D and Saboori S prepared the data tables; and Ankersen DV performed the statistical analyses in collaboration with a statistician; All authors approved the final version of the manuscript.
Supported by Calpro AS; Crohn Colitis patient society Denmark; and North Zealand University Hospital and Ferring Pharmaceuticals.
Institutional review board statement: This study protocol was reviewed and approved by the Danish Ethics Committee and the Danish data protection agency.
Clinical trial registration statement: The study was registered at clinicaltrials.gov, No. NCT02492555.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Ankersen DV has received grants from Ferring Pharmaceuticals, Crohn Colitis patient society Denmark, North Zealand University Hospital and non-financial support from Calpro AS; Weimers P has received grants from Ferring lægemidler and Tillotts Pharma AG as well as non-financial support from Janssen-Cilag A/S, Calpro AS, and Vifor Pharma Nordiska AB; Marker D has received non-financial support from Calpro AS and Pharmacosmos; Bennedsen M has received other financial support from AbbVie, Tillotts, Takeda, MSD and Pfizer; Saboori S has received non-financial support from Janssen-Cilag and Salofalk; Paridaens K is an employee of Ferring Pharmaceuticals; Burisch J has received grants from AbbVie, Takeda, Tillotts Pharma and personal fees from AbbVie, Janssen-Cilag, Celgene, Samsung Bioepis, MSD, Pfizer and Takeda; Munkholm P has none to declare.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Pia Munkholm, MD, Professor, Department of Gastroenterology, North Zealand University Hospital, Frederikssundsvej 30, Frederikssund 3600, Capital region, Denmark. pia.munkholm@regionh.dk
Telephone: +45-48-292078 Fax: +45-48-293611
Received: June 25, 2019
Peer-review started: June 25, 2019
First decision: July 21, 2019
Revised: September 4, 2019
Accepted: September 13, 2019
Article in press: September 13, 2019
Published online: October 28, 2019
Processing time: 126 Days and 1.2 Hours
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: Inflammatory bowel disease; Electronic health; Screening; Disease activity

Core tip: Involving patients with inflammatory bowel disease (IBD) in their disease by home-monitoring of disease activity has been shown to bring patients with IBD significantly faster in remission relative to standard care. However, the optimal way to home-monitor patients with IBD for disease progression or relapse remains to be found. We randomized 102 patients with IBD to screen for disease activity either every third month or whenever the patients felt a need for screening on the ibd.constant-care.com web-application for 1 year. We found that the two screening procedures were equally good in capturing a relapse and bringing about remission.