Back to resultsEffect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
Primary Purpose
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
education ,psycological support and social support
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Diseases
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.
Sites / Locations
- Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University
- Department of Gastroenterology, Huzhou Central Hospital
- Department of Gastroenterology, Ruijin Hospital
- Department of Gastroenterology, Shaoxing Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine follow-up group
IBD Disease Management Research Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Decreased score of Socially activity limited rating
Improvement score of socially activity limited rating after intervention for three months, or one year.
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.
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.
Full Information
NCT ID
NCT05719766
First Posted
January 31, 2023
Last Updated
February 18, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05719766
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
February 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine follow-up group
Arm Type
No Intervention
Arm Title
IBD Disease Management Research Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
education ,psycological support and social support
Intervention Description
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
Primary Outcome Measure Information:
Title
Improved score of Quality of Life after three months
Description
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.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Decreased score of Socially activity limited rating
Description
Improvement score of socially activity limited rating after intervention for three months, or one year.
Time Frame
three months,one year
Title
Decreased score of Hospital Anxiety and Depression Scale
Description
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.
Time Frame
three months,one year
Title
Increasion of disease kownledge
Description
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.
Time Frame
three months,one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan chen, PhD, MD
Phone
+8613757118653
Email
chenyan72_72@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyuan Lu, PhD
Phone
+8618868110373
Email
2322135@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan chen
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan chen, PhD,MD
Phone
+8613757118653
Email
chenyan72_72@zju.edu.cn
Facility Name
Department of Gastroenterology, Huzhou Central Hospital
City
Huzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Liu, PhD
Facility Name
Department of Gastroenterology, Ruijin Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Zhong, PhD,MD
Email
jimmyzj64@medmail.com.cn
Facility Name
Department of Gastroenterology, Shaoxing Central Hospital
City
Shaoxing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yazhen Zhan, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients
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