Clinical trial NCT05719766: Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
Official title: Perspective Study on How Can the Incentive Integrated E-IBD Chronic Disease Management Model Improve the Quality of Life in IBD Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improved score of Quality of Life after three months
timeFrame: three months
Secondary outcomes:
measure: Decreased score of Socially activity limited rating
timeFrame: three months,one year
measure: Decreased score of Hospital Anxiety and Depression Scale
timeFrame: three months,one year
measure: Increasion of disease kownledge
timeFrame: three months,one year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University
city: Huzhou
country: China
facility: Department of Gastroenterology, Huzhou Central Hospital
city: Shanghai
country: China
facility: Department of Gastroenterology, Ruijin Hospital
city: Shaoxing
country: China
facility: Department of Gastroenterology, Shaoxing Central Hospital
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Yan chen
role: STUDY_CHAIR
References: