Mobile App-Based Remote Management Model for IBD Patient
NCT Number: NCT06512792
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Inflammatory Bowel Diseases
Interventions: BEHAVIORAL: Telemedicine management through Mobile APP
Sponsor: Changhai Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-01-01
Completion Date: 2025-12-30
Locations: Changhai Hospital, Shanghai, Shanghai, 200433, China

Summary:
Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition of the intestines, with its incidence showing a significant year-on-year increase in China. Self-management is becoming increasingly important in the treatment and follow-up of IBD. Numerous studies from Europe and North America have demonstrated that telemedicine can effectively manage disease activity, monitor symptoms, provide education, and improve prognosis. However, its application in China is limited, and there is a lack of high-quality clinical research. This study aims to explore the following objectives:

1. Investigate the level of disease awareness among Chinese IBD patients and their needs related to telemedicine;
2. Develop and preliminarily establish a telemedicine management system and operational process for IBD patients based on a mobile application platform;
3. Clarify the impact of telemedicine on disease activity, quality of life, and healthcare resource utilization among Chinese IBD patients.

Primary Outcome Measures: Disease activity, Changes in disease activity scores at six months and one year of follow-up after enrollment were assessed. For UC patients, the modified Mayo score (total score 0-12, with higher scores indicating more severe intestinal lesions) was used. For CD patients, the SES-CD score (total score 0-60, with higher scores indicating more severe intestinal lesions) was utilized., Six months after enrollment，1 year after enrollment
Secondary Outcome Measures: Quality of life assessment, A multidimensional assessment will be conducted using the widely validated and extensively used patient self-assessment scale, the Simple Quality of Life Questionnaire (IBDQ). This scale consists of 32 selected health-related questions (total score 32-224, with higher scores indicating better quality of life)., Six months after enrollment，1 year after enrollment|Psychological assessment, The assessment is conducted using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 emotional questions. The total score ranges from 0 to 42, with higher scores indicating more severe psychological distress in patients., Six months after enrollment，1 year after enrollment|Utilization rate of medical resources, The assessment of healthcare resource utilization will be conducted through a self-administered questionnaire. Follow-up questionnaires will be administered via the WeChat Questionnaire Star platform in the 1st, 2nd, 3rd, 4th, 5th, 7th, 8th, 9th, 10th, and 11th months to evaluate healthcare resource utilization patterns. This questionnaire has been developed through an extensive review of the literature and discussions with relevant experts. Its key components include total number of medical visits, IBD-related hospitalizations, emergency room visits, outpatient visits, endoscopic examinations, and telemedicine consultations.（The more frequently the relevant information is filled out, the lower the utilization of medical resources.）, Each month within the 1 year of enrollment|Ratio of reduced IBD flare-up episodes, The proportion of patients with reduced IBD flare-ups (one year before and after enrollment). IBD patients in a flare-up phase within one month after enrollment were excluded., 1 year after enrollment