]>
IRCT20200613047757N1 IRCT 2021-11-16 Mashhad University of Medical Sciences Designing a mobile-based inflammatory bowel disease management system by using gamification techniques and determining its effectiveness on disease activity index, mental health and quality of life 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 2022-11-22 anticipated 210 Complete https://irct.ir/trial/59842 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, patients' information needs will be extracted during 3 general phases and based on the identified needs, an exclusive educational content for patients will be developed. This system will be used to evaluate its effectiveness on effective factors, Randomization description: 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, Blinding description: 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. N/A Condition 1: Ulcerative Colitis. Condition 2: Crohn Disease. Intervention 1: The method of intervention in the experimental group is education and disease management via mobile phone for 6 months so that it can be trained through educational intervention with playfulness techniques and symptoms related to the disease are monitored and warnings are given to the patient if necessary. To. For remote measurement of disease activity in Crohn's patients, Harvey-Bradshaw index and in patients with ulcerative colitis, simple clinical colitis activity index will be used. Intervention 2: Control group: Patients in the control group will receive standard care and routine outpatient clinics based on guidelines. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Narges Norouzkhani
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2000 narges.norouzkhani@yahoo.com Mashhad University of Medical Sciences scientific Narges Norouzkhani
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
Mashhad Iran (Islamic Republic of) 9138813944 +98 51 3800 2000 narges.norouzkhani@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of inflammatory bowel disease based on internationally accepted diagnostic criteria including clinical signs, endoscopic findings, radiological and histological studies by a physician specializing in gastroenterology and adult liver Minimum age 18 years Willingness to enter the study and complete informed written consent Ability to access and use smart phones and the Internet Ability to read and write in Persian Patients with at least one week on remission Not receiving self-management and education-oriented programs at the same time and participating in another experimental study when registering a patient 18 years 75 years Both Inability to communicate with and match with researchers Reluctance to continue cooperation Pregnancy Active perianal or anal abscess disease Existence of an anastomosis of the bladder Participate in another experimental study that may interfere with this study Having other chronic and acute diseases diagnosed by a doctor such as liver, kidney, circulatory system and acute mental disorder K51 K50 Ulcerative colitis Crohn's disease [regional enteritis] Other N/A The method of intervention in the experimental group is education and disease management via mobile phone for 6 months so that it can be trained through educational intervention with playfulness techniques and symptoms related to the disease are monitored and warnings are given to the patient if necessary. To. For remote measurement of disease activity in Crohn's patients, Harvey-Bradshaw index and in patients with ulcerative colitis, simple clinical colitis activity index will be used. Control group: Patients in the control group will receive standard care and routine outpatient clinics based on guidelines. Quality of life index. Timepoint: At the beginning of the study, 3 and 6 months after the intervention. Method of measurement: will be measured by a 32-item Inflammatory Bowel Disease Questionnaire. Disease activity index. Timepoint: At the beginning of the study, 3 and 6 months after the intervention. Method of measurement: Harvey-Bradshaw Index (HBI) for Crohn's disease and Simple Clinical Colitis Activity Index (SCCAI) for Ulcerative Colitis patients. Hospital Anxiety and Depression. Timepoint: At the beginning of the study, 3 and 6 months after the intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Self-Efficacy Scale. Timepoint: At the beginning of the study, 3 and 6 months after the intervention. Method of measurement: IBD Self-efficacy Scale. Measure non-adherence. Timepoint: At the beginning of the study, 3 and 6 months after the intervention. Method of measurement: Morisky Medication Adherence Scale. Mashhad University of Medical Sciences Approved 2021-11-07 Mashhad University of Medical Sciences Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)