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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05719766
Collaborator
(none)
200
4
2
47.9
50
1

Study Details

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.We firstly identify the IBD patients in need of empowerment disease activities through the questionnaire .Then, we 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, we complete the empowerment process of IBD patients' self-management initiative and self-management ability, through the internet. Finally ,we evaluate the quality of life(QoL), social participation,disease self-management level via questionnaire . Our primary outcome is the improvement of QoL score after three months' intervention.

Condition or Disease Intervention/Treatment Phase
  • Other: education ,psycological support and social support
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Perspective Study on How Can the Incentive Integrated E-IBD Chronic Disease Management Model Improve the Quality of Life in IBD Patients
Anticipated Study Start Date :
Feb 3, 2023
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Feb 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. QoL improvement after three months [three months]

    Improvement score of quality of life after intervention for three months

Secondary Outcome Measures

  1. Socially activity limited rating [three months,one year]

    Improvement score of socially activity limited rating after intervention for three months, or one year.

  2. HADS [three months,one year]

    improvement score of anxiety or depression via HADS-A/D after intervention for three months, or one year.

  3. disease kownledge [three months,one year]

    improvement of disease kownledge via CCKOWN after intervention for three months, or one year.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou China 310009
2 Department of Gastroenterology, Huzhou Central Hospital Huzhou China
3 Department of Gastroenterology, Ruijin Hospital Shanghai China
4 Department of Gastroenterology, Shaoxing Central Hospital Shaoxing China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Yan chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05719766
Other Study ID Numbers:
  • 20230049
First Posted:
Feb 9, 2023
Last Update Posted:
Feb 9, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2023