Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
Perspective Study on How Can the Incentive Integrated E-IBD Chronic Disease Management Model Improve the Quality of Life in IBD Patients
1 other identifier
interventional
200
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
February 21, 2023
January 1, 2023
3.8 years
January 31, 2023
February 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Decreased score of Socially activity limited rating
three months,one year
Decreased score of Hospital Anxiety and Depression Scale
three months,one year
Increasion of disease kownledge
three months,one year
Study Arms (2)
Routine follow-up group
NO INTERVENTIONIBD Disease Management Research Group
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Clinically diagnosed IBD patients,according to the criteria of the Inflammatory Bowel Group of the Gastroenterology Branch of the Chinese Medical Association in 2018;
- Aged 18 to 75 years old;
- Understand and comply with the requirements of the program and sign informed consent.
- Identified as need intervention according to the patient identification questionnaire screening;
- Patients with the ability to complete all course training and/or follow-up work;
- Enrolled at least one year ahead of end of this study(for garantee of enough folllow-up time).
You may not qualify if:
- Unable or unwilling to sign the consent form, or unable to follow the research procedure;
- Patients who have had a stoma or ileorectal anastomosis (partial scales are not available);
- Patients who do not complete training on time or do not complete follow-up assessments in their entirety;
- Patients with other malignancies or life-threatening complications；
- Pregnancy or lactation；
- Patients whose remaining follow-up time less than one year before the end of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, 310009, China
Department of Gastroenterology, Huzhou Central Hospital
Huzhou, China
Department of Gastroenterology, Ruijin Hospital
Shanghai, China
Department of Gastroenterology, Shaoxing Central Hospital
Shaoxing, China
Related Publications (1)
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yan chen
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
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
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 9, 2023
Study Start
April 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
February 21, 2023
Record last verified: 2023-01