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Clinical Trials/NCT05719766
NCT05719766Not yet recruitingNot Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University4 sites in 1 country200 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
200
Locations
4
Primary Endpoint
Improved score of Quality of Life after three months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Increasion of disease kownledge(three months,one year)
  • Decreased score of Socially activity limited rating(three months,one year)
  • Decreased score of Hospital Anxiety and Depression Scale(three months,one year)

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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