An interventional study of Telemedicine management through Mobile APP in Inflammatory Bowel Diseases, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Supportive care
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:
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:
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's planned enrollment of 500 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Behavioral: Telemedicine management through Mobile APP
The control group received no guidance and only standard traditional care services (i.e., prescribed medication and regular outpatient follow-up).
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.
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.
Time frame: Six months after enrollment，1 year after enrollment
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).
Time frame: 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.
Time frame: 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.）
Time frame: 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.
Time frame: 1 year after enrollment
Plan to share: No
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