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Randomized Controlled Trial
. 2019 Oct 28;25(40):6158-6171.
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  1 , Petra Weimers  1 , Dorte Marker  1 , Mette Bennedsen  1 , Sanaz Saboori  1 , Kristine Paridaens  2 , Johan Burisch  1 , Pia Munkholm  3
Affiliations
Randomized Controlled Trial

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 et al. World J Gastroenterol. .

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.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Disease activity algorithm in the constant care application consisting of the simple clinical colitis activity index for patients having ulcerative colitis or the Harvey-Bradshaw Index for patients having Crohn’s disease, plus a validated FC home test. The total inflammation burden score algorithm is presented as a traffic light system to patients and eCare providers. A: The algorithm of a patient with ulcerative colitis treated with 5-aminosalicylates only; B: Disease activity cut-off values of the algorithm. SCCAI: Simple clinical colitis activity index; HBI: Harvey-Bradshaw Index; TIBS: Total inflammation burden scoring; FC: Fecal calprotectin.
Figure 2
Figure 2
Flow chart of inclusion and follow-up of patients with inflammatory bowel disease. OD: On demand; 3M: Third month.
Figure 3
Figure 3
No significant difference was found in the mean length of time spent in remission or active disease throughout 1 year for the two screening procedures of fecal calprotectin, illustrated with an enlarged circle and cross. The length of time spent in FC remission (green), moderate activity (yellow), and severe activity (red) by each patient is represented by small circles (on demand) and crosses (every third month). The distance (perpendicular) from a small circle or cross within the triangle to a side of the triangle represents the length of time spent in that FC zone. FC: Fecal calprotectin.
Figure 4
Figure 4
Analyzed by fecal calprotectin and simple clinical colitis activity index for all patients at risk. A: Time to severe relapse (in days) measured by fecal calprotectin for all patients at risk (n = 83); B: The corresponding (days) to remission (n = 27); C: Time in days to a severe relapse measured by simple clinical colitis activity index for all patients with ulcerative colitis at risk (n = 70); D: The corresponding time (days) to remission (n = 16). The two electronic health screening procedures (every third month and on demand) are represented by blue and red lines, respectively.
Figure 5
Figure 5
Patient-reported satisfaction with the study, n = 88. Black = missing, dark gray = Yes, and light gray = No.
See this image and copyright information in PMC

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