Evaluation of the effectiveness of mobile-based inflammatory bowel disease management system by using gamification techniques on disease activity index, mental health and quality of life

Comparison of disease activity index, quality of life and anxiety and depression, self-efficacy and drug adherence

Study of a three-phase, multi-center randomized clinical trial with two intervention and comparison groups designed in the intervention group to evaluate the mobile-based game program and a control group to evaluate the effect of mobile-based self-management system using gamification indicators On the indicators of self-management in patients with intestinal inflammation. The study population included all patients with inflammatory bowel disease. The goal is to include about 210 patients with inflammatory bowel disease in this study. Eligible patients will use a web-based tool to randomize the categorized classification.

Special gastrointestinal clinic of Mashhad and Babol University of Medical Sciences

Inclusion criteria: Diagnosis of inflammatory bowel disease based on internationally accepted diagnostic criteria; Minimum age 18 years; Willingness to enter the study and complete informed written consent; Ability to access and use smartphones and read and write in Persian; Patients with at least one week off; Do not receive self-management programs at the same time. Exclusion criteria: Inability to communicate with researchers; Pregnancy; Active perianal or anal abscess disease; Existence of an anastomosis of the bladder; Having other chronic and acute diseases.

This clinical trial study will have 2 arms: Control group: Patients in the control group will receive standard and routine outpatient clinics based on guidelines. Intervention group: will receive a mobile-based inflammatory bowel disease management system using playfulness techniques in addition to standard care.

Quality of Life; Disease activity; Stress; depression

Combination of two methods of randomization, balanced blocks, and stratification. First, a randomized list will be generated for each center by randomization.com. Then, cards and envelopes will be prepared according to the number of samples. The cards will be placed in opaque envelopes in the order of the random allocation list created by the randomization system. Also, to keep the generated order of the cards, the serial number will be written on the envelopes. The purpose of the study will be explained to the person who accepts to participate signs the informed consent form. They will take an envelope, and will enter the intervention or control groups based on the contents of the envelope.

Researchers and those involved in this research are blind to random order. After generating the randomization list, cards and envelopes will be prepared in the number of samples. The cards will be placed in the envelope in the order of the random allocation list created by the randomization system so that its contents are not visible from outside the envelope. Also, to prevent the order of the cards from being disturbed, the serial number is inserted on the envelopes. The purpose of the study is explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope and then opens it and enters the intervention or control groups based on the contents of the envelope. The person's details include the patient's name, age, mobile number, and the doctor's name on the envelope. Finally, if patients enter the intervention group, the designed program will be installed on the patient or his mobile phone.