Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients

Ulcerative Colitis Clinical Trial

Official title:

Perspective Study on How Can the Incentive Integrated E-IBD Chronic Disease Management Model Improve the Quality of Life in IBD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05719766
• Other study ID #: 20230049
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: January 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yan chen, PhD, MD
• Phone: +8613757118653
• Email: chenyan72_72[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to prospectively explore the effect of incentive-integrated E-IBD (electronic inflammatory bowel disease) chronic disease management model on the improvement of IBD quality of life, and provide a more effective chronic disease management model for improving the quality of life and social participation of IBD patients.The investigators firstly identify the IBD patients in need of empowerment disease activities through the questionnaire .Then, the investigators feedback the patients' education content according to their needs found.Based on the social support network of patient organization and the medical support network of tertiary medical institutions, the investigators complete the empowerment process of IBD patients' self-management initiative and self-management ability, through the internet. Finally ,the investigators evaluate the quality of life(QoL), social participation,disease self-management level via questionnaire . The primary outcome is the improvement of QoL score after three months' intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1.Clinically diagnosed IBD patients,according to the criteria of the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018;

• 2.Aged 18 to 75 years old;

• 3.Understand and comply with the requirements of the program and sign informed consent.

• 4.Identified as need intervention according to the patient identification questionnaire screening;

• 5.Patients with the ability to complete all course training and/or follow-up work;

• 6.Enrolled at least one year ahead of end of this study(for garantee of enough folllow-up time).

Exclusion Criteria:

• 1.Unable or unwilling to sign the consent form, or unable to follow the research procedure;

• 2.Patients who have had a stoma or ileorectal anastomosis (partial scales are not available);

• 3.Patients who do not complete training on time or do not complete follow-up assessments in their entirety;

• 4.Patients with other malignancies or life-threatening complications;

• 5.Pregnancy or lactation;

• 6.Patients whose remaining follow-up time less than one year before the end of this study.

Related Conditions & MeSH terms

• Chronic Disease
• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Other:
• education ,psycological support and social support
we would give targeted-education according to our patients' need(reflected via questionnaire; we would provide psycological and social support to patients based on their need reflected by questionnaire

Locations

Country	Name	City	State
China	Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou
China	Department of Gastroenterology, Huzhou Central Hospital	Huzhou
China	Department of Gastroenterology, Ruijin Hospital	Shanghai
China	Department of Gastroenterology, Shaoxing Central Hospital	Shaoxing

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved score of Quality of Life after three months	Improvement score of quality of life via short inflammatory bowel disease questionnaire(SIBDQ, score scale:0~70 points) after intervention for three months,higher scores mean better quality of life.	three months
Secondary	Decreased score of Socially activity limited rating	Improvement score of socially activity limited rating after intervention for three months, or one year.	three months,one year
Secondary	Decreased score of Hospital Anxiety and Depression Scale	improvement score of anxiety or depression via Hospital Anxiety and Depression Scale after intervention for three months, or one year. Lower scores mean the less anxiety or depression of the patients.	three months,one year
Secondary	Increasion of disease kownledge	improvement of disease kownledge via Crohn's and Colitis Knowledge Score(CCKOWN, score scale: 0~24 points) after intervention for three months, or one year. Higher scores mean better knowledge.	three months,one year