Abstract

A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients

McCombie A1, Walmsley R2, Barclay M3, Ho C4, Langlotz T5, Regenbrecht H4, Gray A6, Visesio N7, Inns S8, Schultz M9. Inflamm Bowel Dis. 2019 Oct 23. pii: izz252. doi: 10.1093/ibd/izz252. [Epub ahead of print]

 
     

Author information

University of Otago, Dunedin, New Zealand.

University of Auckland and Department of Gastroenterology, Waitemata District Health Board, Auckland, New Zealand.

University of Otago and Department of Gastroenterology, Canterbury District Health Board, Christchurch, New Zealand.

Department of Gastroenterology, Southern District Health Board, Dunedin, New Zealand.

Department of Information Science, University of Otago, Dunedin, New Zealand.

Centre for Biostatistics, University of Otago, Dunedin, New Zealand.

Department of Gastroenterology, Waitemata District Health Board, Auckland, New Zealand.

Department of Medicine, University of Otago, Wellington, New Zealand and Department of Gastroenterology, Hutt Valley District Health Board, Lower Hutt, New Zealand.

Department of Medicine, University of Otago, and Department of Gastroenterology, Southern District Health Board, Dunedin, New Zealand.

Abstract

BACKGROUND: Providing timely follow-up care for patients with inflammatory bowel disease in remission is important but often difficult because of resource limitations. Using smartphones to communicate symptoms and biomarkers is a potential alternative. We aimed to compare outpatient management using 2 smartphone apps (IBDsmart for symptoms and IBDoc for fecal calprotectin monitoring) vs standard face-to-face care. We hypothesized noninferiority of quality of life and symptoms at 12 months plus a reduction in face-to-face appointments in the smartphone app group.

METHODS: Inflammatory bowel disease outpatients (previously seen more often than annually) were randomized to smartphone app or standard face-to-face care over 12 months. Quality of life and symptoms were measured quarterly for 12 months. Acceptability was measured for gastroenterologists and patients at 12 months.

RESULTS: One hundred people (73 Crohn's disease, 49 male, average age 35 years) consented and completed baseline questionnaires (50 in each group). Intention-to-treat and per-protocol analyses revealed noninferiority of quality of life and symptom scores at 12 months. Outpatient appointment numbers were reduced in smartphone app care (P < 0.001). There was no difference in number of surgical outpatient appointments or number of disease-related hospitalizations between groups. Adherence to IBDsmart (50% perfect adherence) was slightly better than adherence to IBDoc (30% perfect adherence). Good acceptability was reported among most gastroenterologists and patients.

CONCLUSIONS: Remote symptom and fecal calprotectin monitoring is effective and acceptable. It also reduces the need for face-to-face outpatient appointments. Patients with mild-to-moderate disease who are not new diagnoses are ideal for this system.

CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12615000342516.

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