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

Not Applicable

Not yet recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Interventions: Other: education ,psycological support and social support

• Registration Number: NCT05719766
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21
• Study Start: 2023-04-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBD Disease Management Research Group	education ,psycological support and social support	-

Primary Outcome Measures

Name	Time	Method
Improved score of Quality of Life after three months	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.

Secondary Outcome Measures

Name	Time	Method
Increasion of disease kownledge	three months,one year	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.
Decreased score of Hospital Anxiety and Depression Scale	three months,one year	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.
Decreased score of Socially activity limited rating	three months,one year	Improvement score of socially activity limited rating after intervention for three months, or one year.

Trial Locations

Locations (4)

Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China

Department of Gastroenterology, Shaoxing Central Hospital; 🇨🇳 Shaoxing, China

Department of Gastroenterology, Huzhou Central Hospital; 🇨🇳 Huzhou, China

Department of Gastroenterology, Ruijin Hospital; 🇨🇳 Shanghai, China