Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512792
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-18
Brief Title:
Mobile App-Based Remote Management Model for IBD Patient
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mobile App-Based Remote Management Model for IBD Patients A Multi-Center Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None