Mobile app for managing Inflammatory Bowel Disease

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

This study is testing a new mobile app to help people with Inflammatory Bowel Disease in China manage their condition better and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Changhai Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06512792 on ClinicalTrials.gov

What this trial studies

This study focuses on developing a mobile app-based telemedicine management system for patients with Inflammatory Bowel Disease (IBD) in China. It aims to assess the awareness and needs of IBD patients regarding telemedicine through surveys and interviews, while also establishing a system for monitoring disease activity and providing personalized health management. The study will involve over 1,000 patients nationwide and will utilize the WeChat platform for data collection and patient engagement. The goal is to improve disease management and quality of life for IBD patients through innovative technology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with IBD who have experienced an active phase of the disease within the last two years.

Not a fit: Patients with a history of surgical treatment for IBD or uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance disease management and improve the quality of life for patients with IBD.

How similar studies have performed: Other studies in Europe and North America have shown success with telemedicine approaches for managing IBD, but this application in China is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Participants must be between the ages of 18 and 75 and provide signed informed consent for the project.
3. 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).

Exclusion Criteria:

1. Participants deemed unable to adhere to the study protocol as determined by the investigators.
2. Individuals with a history of surgical treatment for IBD or those scheduled to undergo surgery.
3. Uncontrolled internal medicine or psychiatric disorders.
4. Pregnant individuals or those planning to become pregnant during the enrollment and follow-up period.

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Xuanming Fan, M.D.

Conditions: Inflammatory Bowel Diseases, Telemedicine, Mobile APP, Inflammatory Bowel Disease, Daily Management, Disease Activity, Randomized controlled