Clinical trial NCT06512792: Mobile App-Based Remote Management Model for IBD Patient
Official title: Mobile App-Based Remote Management Model for IBD Patients: A Multi-Center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Telemedicine
Mobile APP
Inflammatory Bowel Disease
Daily Management
Disease Activity
Randomized controlled
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: IBD patients meeting the inclusion criteria will be stratified and randomly assigned to either the intervention group or the control group. Participants in the intervention group will undergo remote healthcare management by the researchers through the WeChat platform, including the establishment of electronic health records, health management monitoring, risk warning and intervention, and health education. On the other hand, participants in the control group will receive no specific guidance and will only receive standard traditional treatment services (i.e., medication according to prescription and routine outpatient follow-ups).Colonoscopy will be required for endoscopic assessment at baseline and at the 12-month follow-up. Additionally, participants will be surveyed monthly for one year to assess the utilization of healthcare resources. At the baseline, 6-month, and 12-month visits, researchers will evaluate disease activity, quality of life , and healthcare resource utilization.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Disease activity
timeFrame: Six months after enrollment，1 year after enrollment
Secondary outcomes:
measure: Quality of life assessment
timeFrame: Six months after enrollment，1 year after enrollment
measure: Psychological assessment
timeFrame: Six months after enrollment，1 year after enrollment
measure: Utilization rate of medical resources
timeFrame: Each month within the 1 year of enrollment
measure: Ratio of reduced IBD flare-up episodes
timeFrame: 1 year after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, Professor
role: STUDY_DIRECTOR
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