Mobile App-Based Remote Management Model for IBD Patient

July 16, 2024 updated by: Zhaoshen Li, Changhai Hospital

Mobile App-Based Remote Management Model for IBD Patients: A Multi-Center Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing telemedicine interventions
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
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.
No Intervention: IBD patients receiving traditional medical care
The control group received no guidance and only standard traditional care services (i.e., prescribed medication and regular outpatient follow-up).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: Six months after enrollment，1 year after enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment
Time Frame: Six months after enrollment，1 year after enrollment
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).
Six months after enrollment，1 year after enrollment
Psychological assessment
Time Frame: Six months after enrollment，1 year after enrollment
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.
Six months after enrollment，1 year after enrollment
Utilization rate of medical resources
Time Frame: Each month within the 1 year of enrollment
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.）
Each month within the 1 year of enrollment
Ratio of reduced IBD flare-up episodes
Time Frame: 1 year after enrollment
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.
1 year after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Director: Zhaoshen Li, Professor, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2024-210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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