Usability of IBDoc, a Novel Fecal Calprotectin Home-Based Rapid Test in Clinical Practice

Abstract

The aim of this study was to examine sustained usability and adherence to a fecal calprotectin (FC) home-based rapid test in an inflammatory bowel disease (IBD) monitoring program in clinical practice. Methods In total, 59 consecutive IBD outpatients were recruited. The participants were asked to measure FC with a home-based rapid test, IBDoc, every second month for a period of 14 months. At start and termination of this time period, they were invited to answer a questionnaire concerning the IBDoc device. The participants were also asked to deliver one stool sample for FC to be analyzed with enzyme-linked immunosorbent assay and analyze the same sample with the home-based FC test at start and termination. Results In total, one-third (34%) of the participants were adherent to the IBDoc program. No patient characteristics were significantly associated with being adherent. The home-based test correlated well with enzyme-linked immunosorbent assay method (Spearman rank correlation coefficient was 0.92, P < 0.001 and 0.74, P < 0.001, at study start and termination, respectively). After having used the IBDoc for over a year, all except for 1 of the 36 participants answering the follow-up questionnaire completely agreed with the statement “I would like to use IBDoc in the future.” Conclusions We found a low adherence to home-based FC measurements every second month for a period of 14 months. Nevertheless, all but 1 of the 36 participants who answered the follow-up questionnaire were interested in continuing using the IBDoc test.