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P630 A non-inferiority randomised clinical trial of the use of the smartphone-based health applications IBDsmart and IBDoc® in the care of inflammatory bowel disease patients

R. Walmsley*1, A. McCombie2, M. Barclay2, N. Visesio1, C. Ho3, S. Brown4, K. Rosser5, S. Inns4, A. Gray6, H. Regenbrecht6, T. Langlotz6, M. Schultz6

1Waitemata District Health Board, Gastroenterology, Auckland, New Zealand, 2University of Otago, Medicine, Christchurch, New Zealand, 3Southern District Health Board, Gastroenterology, Dunedin, New Zealand, 4Hutt Valley District Health Board, Gastroenterology, Hutt, New Zealand, 5Canterbury District Health Board, Gastroenterology, Christchurch, New Zealand, 6University of Otago, Gastroenterology, Dunedun, New Zealand

Background

Using smartphones to communicate symptoms and biomarkers is a potentially cost-effective and quality-of-care equivalent method for managing inflammatory bowel disease (IBD). We aim to compare the management of IBD using two smartphone apps (IBDsmart for symptom monitoring and IBDoc® for faecal calprotectin [FC] monitoring) vs. standard face-to-face (F2F) outpatient care. We hypothesised non-inferiority of quality of life (QoL) and symptoms with a reduction in standard F2F appointments in the smartphone app group. Assessment was made of adherence and usability of the apps.

Methods

Adult IBD outpatients (usually seen more often than annually) were randomised to smartphone app or standard F2F care for 12 months. The smartphone app group sent their self-reported disease activity index scores (Harvey–Bradshaw Index [HBI] for Crohn’s disease and Simple Clinical Colitis Activity Index [SCCAI] for ulcerative colitis) and FC scores 3-monthly and were not seen F2F unless they had a disease flare or specifically requested. Those in F2F care were seen as usual during the study period (i.e. 3 or 6 monthly). QoL was measured via the IBD Questionnaire (IBDQ) at 0, 3, 6, 9, and 12 months. At 12 months, the smartphone app group completed a system usability scale for IBDsmart and for IBDoc® and doctor usability was assessed. Australian New Zealand Clinical Trials Registry (ACTRN12615000342516).

Results

In total, 107 patients were recruited between August 2015 and December 2016 from four District Health Boards. One hundred people (73 Crohn’s disease, 49 males, average age 35 years) consented and completed baseline questionnaires (50 in each group). There was no difference in IBDQ, HBI, and SCCAI between the two groups. Outpatient appointment numbers were 1.7 (SD 0.8) in standard F2F care vs. 0.6 (0.9) in smartphone app care (p < 0.001). There was no difference in the number of surgical outpatient appointments or IBD-related hospitalisations. Usability: 82% completed >50% of the IBDsmart indices and 72% completed more than half of the IBDoc tests®. Patient-reported system usability scores were 81.37 (SD 14.08) for IBDsmart and 71.6 (16.76) for IBDoc®. Fifty-eight per cent of patients felt comfortable using the apps to report symptoms instead of F2F appointments. The gastroenterologist was very or somewhat comfortable using IBDsmart/IBDoc® in 78% of cases. The gastroenterologist said IBDsmart/IBDoc® adequately replaced F2F appointments in 58%. In 54% of cases, the gastroenterologist claimed there was something they were not able to communicate with patients via the apps (c.f. 10% when seeing them F2F).

Conclusion

Use of IBDsmart and IBDoc® in routine clinical care of IBD patients over 12 months is demonstrated to be acceptable, usable, and non-inferior to standard clinic-based care.