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
ARTICLE HIGHLIGHTS
Research background

Home-monitoring of disease activity in inflammatory bowel disease (IBD) has previously been shown to reduce time to remission, hospital admissions and outpatient visits, to increase compliance with medical therapy and quality of life and to empower patients. However, no study has investigated how often adult patients with IBD should home-monitor for disease activity. This study showed that the electronic health (eHealth), on demand (OD) screening procedure was cheaper and equally good on all disease measures as screening every third month (3M).

Research motivation

The optimal way to home-monitor adult patients with IBD for disease progression or relapse remains to be found.

Research objectives

To determine whether an eHealth screening procedure for disease activity in adult patients with IBD should be implemented in clinical practice, scheduled every third month, 3M or according to patient own decision, OD.

Research methods

A randomized 1-year open-label eHealth trial where adult patients were randomized to screen for disease activity, quality of life, fatigue and medical compliance every 3M or OD on the web-application ibd.constant-care.com.

Research results

There was no statistical difference between the two screening procedures regarding medical compliance, fatigue, quality of life, mean time spent in remission, overall fecal calprotectin (FC) relapse rates, FC disease courses and FC time to a severe relapse and remission. The on-demand screening approach used fewer FC home-monitoring test-kits than screening every third month.

Research conclusions

The two eHealth screening procedures were equally good in capturing a relapse and bringing about remission. The on-demand screening protocol used fewer FC home test-kits per patient. Individualized screening procedures can be recommended for adult patients with IBD in clinical web-practice.

Research perspectives

A validation of the eHealth disease algorithm [total inflammation burden score (TIBS)] by endoscopy should be performed and time to a moderate and severe relapse of the TIBS between the two screening protocols should also be further examined.