NCT06512792

Mobile App-Based Remote Management Model for IBD Patient

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To investigate the level of awareness among Chinese IBD (Inflammatory Bowel Disease) patients about their condition and their needs regarding telemedicine, a survey questionnaire has been designed. The questionnaire includes sections on basic knowledge of IBD, treatment methods, daily management, and telemedicine needs. The content of the questionnaire will be discussed and finalized by a team of experts, and then distributed through the Wenjuanxing platform via the WeChat app across multiple centers nationwide, with an expected participation of over 1,000 patients. Additionally, researchers will conduct semi-structured interviews with 50 IBD patients from Changhai Hospital to understand their most concerning symptoms and issues. The results of these interviews will be used to create educational materials for patients. To construct and operate a telemedicine management system for IBD patients based on the WeChat platform, the following steps will be taken: 1. Establishing Electronic Health Records (EHRs): Each enrolled patient will have an EHR containing personal information, disease history, disease behavior, and treatment details. 2. Health Management Monitoring: Researchers will provide personalized medication and follow-up reminders based on the EHRs. Patients will be encouraged to monitor their health at home, regularly record clinical symptoms, medication, diet, and exercise, and upload this information to the WeChat platform. Self-assessment questionnaires will be distributed periodically via Wenjuanxing to evaluate disease activity, quality of life, sleep, and psychological status, with results recorded in the EHRs. 3. Personalized Recommendations and Interventions: Researchers will assess potential disease risks based on clinical symptoms, self-assessment questionnaires, and medical test results, sending alerts and providing targeted information and interventions. 4. Health Education and Communication: Using results from semi-structured interviews, a health education resource library will be developed, including IBD knowledge, treatment, and daily management in various formats. Weekly personalized education sessions will be provided, and doctor-patient WeChat groups will be established for ongoing interaction, health consultations, and patient discussions. This section outlines a 12-month, multicenter, randomized controlled clinical trial involving 500 IBD patients across five centers in China. The study aims to explore the impact of WeChat-based telemedicine on disease activity, quality of life, and healthcare resource utilization among IBD patients. Eligible patients will be randomly assigned to either an intervention group or a control group. The intervention group will receive telemedicine management via WeChat, including the establishment of electronic health records, health monitoring, risk alerts, and education, while the control group will receive standard traditional care without additional guidance. All participants will undergo research visits at baseline, 6 months, and 12 months, with colonoscopies required at baseline and 12 months for endoscopic evaluation. Monthly follow-ups via Wenjuanxing will assess healthcare resource utilization. Disease activity (primary endpoint), quality of life, and healthcare resource utilization (secondary endpoints) will be evaluated at baseline, 6 months, and 12 months.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Telemedicine management through Mobile APP	According to the patient's electronic health records, each participating center researcher conducts personalized medication reminders and follow-up reminders for enrolled patients on a one-on-one basis. Simultaneously, patients are advised to monitor their health at home, regularly record and upload changes in clinical symptoms, medication, diet, exercise, etc., on the Mobile APP platform. Periodically, self-assessment scales are distributed through the Questionnaire Star platform to assess and record the patient's disease activity, quality of life, sleep, psychological status, etc., and update the information in the electronic health records.Based on the patient's clinical symptoms, self-assessment scales, and feedback from medical institution tests and examinations, each participating center researcher will promptly assess potential health risks, send warning alerts, and provide targeted informational support and interventions.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-07-30
• Completion: 2025-12-30
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: China