Mobile App-Based Remote Management Model for IBD Patient
Mobile App-Based Remote Management Model for IBD Patients: A Multi-Center Randomized Controlled Study
Changhai Hospital
500 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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).
Exclusion Criteria4
- Participants deemed unable to adhere to the study protocol as determined by the investigators.
- Individuals with a history of surgical treatment for IBD or those scheduled to undergo surgery.
- Uncontrolled internal medicine or psychiatric disorders.
- Pregnant individuals or those planning to become pregnant during the enrollment and follow-up period.
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Interventions
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.
Locations(1)
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NCT06512792