Mobile App-Based Remote Management Model for IBD Patient

NCT06512792 | Recruiting DMC

• 1 other identifier: CHEC2024-210
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.Investigate the level of disease awareness among Chinese IBD patients and their needs related to telemedicine;
2. 2.Develop and preliminarily establish a telemedicine management system and operational process for IBD patients based on a mobile application platform;
3. 3.Clarify the impact of telemedicine on disease activity, quality of life, and healthcare resource utilization among Chinese IBD patients.

Conditions

Inflammatory Bowel Diseases

Keywords

Telemedicine; Mobile APP; Inflammatory Bowel Disease; Daily Management; Disease Activity; Randomized controlled

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months after enrollment，1 year after enrollment

Secondary Outcomes (4)

• Quality of life assessment

  Six months after enrollment，1 year after enrollment

• Psychological assessment

  Six months after enrollment，1 year after enrollment

• Utilization rate of medical resources

  Each month within the 1 year of enrollment

• Ratio of reduced IBD flare-up episodes

  1 year after enrollment

Study Arms (2)

Patients undergoing telemedicine interventions

EXPERIMENTAL

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

IBD patients receiving traditional medical care

NO INTERVENTION

The control group received no guidance and only standard traditional care services (i.e., prescribed medication and regular outpatient follow-up).

Interventions

Telemedicine management through Mobile APP BEHAVIORAL

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.

Patients undergoing telemedicine interventions

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

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MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Zhaoshen Li, Professor

  Changhai Hospital

  STUDY DIRECTOR

Central Study Contacts

Xuanming Fan, M.D.

CONTACT

+86-18301972695; fan18301972695@163.com

Yu Bai, Professor

CONTACT

+86-13564665324; md.baiyu@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: July 22, 2024
• Study Start: January 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)