Effect of a gamified mobile‐based self‐management application on disease activity index, quality of life, and mental health in adults with inflammatory bowel disease: A protocol of a randomized controlled trial study.

Background and Aims: Inflammatory bowel disease (IBD) is a chronic inflammatory gastrointestinal tract disease subdivided into Crohn's disease (CD) and ulcerative colitis (UC). There is currently no cure for IBD, and individuals with IBD frequently experience a lower health‐related quality of life (HRQOL) than the general population. Gamification has become an increasingly popular topic in recent years. Adapting game design concepts to nongaming contexts represents a novel and potential approach to changing user engagement. This study will be conducted with the aim of evaluating the effect of a gamified mobile‐based self‐management application on disease activity index, quality of life, and mental health in adults with IBD. Methods: A multicenter, parallel, two‐arm, exploratory randomized controlled trial with a 6‐month follow‐up per patient will be designed to compare the impact of the gamified mobile‐based tele‐management system on primary and secondary health outcomes and outpatient visits in 210 patients with all types of IBD which are divided equally into a control group with standard care and an intervention group which will use the developed mobile application named MY IBD BUDDY. All patients will attend study visits at baseline, 12 and 24 weeks, and routine IBD clinic visits or telephone consultations based on randomization group assignment. Disease activity or disease activity index, mental health (anxiety and depression) symptoms, quality of life, self‐efficacy, and IBD‐specific knowledge will be measured at baseline with two follow‐ups at 12 and 24 weeks. Conclusions: In sum, the outcomes of our trial will demonstrate the impact of the gamified mobile‐based self‐management system on disease activity, quality of life, and anxiety and depression by means of interactive care and patient empowerment. Trial Registration: IRCT: IRCT20200613047757N1. Registered November 16, 2021. Prospectively registered and visible at OSF (https://doi.org/10.17605/OSF.IO/AWFY9). [ABSTRACT FROM AUTHOR]