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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05719766
Enrollment
200
Registered
2023-02-09
Start date
2023-04-01
Completion date
2027-02-01
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis

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.

Interventions

OTHEReducation ,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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Improved score of Quality of Life after three monthsthree monthsImprovement 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

MeasureTime frameDescription
Decreased score of Socially activity limited ratingthree months,one yearImprovement score of socially activity limited rating after intervention for three months, or one year.
Decreased score of Hospital Anxiety and Depression Scalethree months,one yearimprovement 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 kownledgethree months,one yearimprovement 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.

Countries

China

Contacts

Primary ContactYan chen, PhD, MD
chenyan72_72@zju.edu.cn+8613757118653
Backup ContactShiyuan Lu, PhD
2322135@zju.edu.cn+8618868110373

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026