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

February 18, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China, 310009
        • Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Huzhou, China
        • Department of Gastroenterology, Huzhou Central Hospital
      • Shanghai, China
        • Department of Gastroenterology, Ruijin Hospital
      • Shaoxing, China
        • Department of Gastroenterology, Shaoxing Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine follow-up group
Experimental: IBD Disease Management Research Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved score of Quality of Life after three months
Time Frame: 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

January 1, 2027

Study Completion (Anticipated)

February 1, 2027

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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