Mobile App-Based Remote Management Model for IBD Patients: A Multi-Center Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Patients will be diagnosed with IBD based on the diagnostic criteria outlined in the Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing). The diagnosis will be established by combining clinical symptoms, endoscopic examination results, imaging findings, and histological examination results.

• Participants must be between the ages of 18 and 75 and provide signed informed consent for the project.

• Within the two years prior to enrollment, medical records must show at least one instance assessed as an inflammatory active phase (Mayo score ≥ 3 or CDAI score ≥ 150).

Locations
Other Locations
China
Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xuanming Fan, M.D.
fan18301972695@163.com
+86-18301972695
Backup
Yu Bai, Professor
md.baiyu@foxmail.com
+86-13564665324
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 500
Treatments
Experimental: Patients undergoing telemedicine interventions
Participants in the intervention group received telemedicine management from researchers through the mobile app platform (establishing electronic health records, health management monitoring, risk warning and intervention, health education).
No_intervention: IBD patients receiving traditional medical care
The control group received no guidance and only standard traditional care services (i.e., prescribed medication and regular outpatient follow-up).
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov