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

NCT ID: NCT05719766

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2027-02-01

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Routine follow-up group

Group Type: NO_INTERVENTION

No interventions assigned to this group

IBD Disease Management Research Group

Group Type: EXPERIMENTAL

education ,psycological support and social support

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan chen

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, , China

Department of Gastroenterology, Huzhou Central Hospital

Huzhou, , China

Department of Gastroenterology, Ruijin Hospital

Shanghai, , China

Department of Gastroenterology, Shaoxing Central Hospital

Shaoxing, , China

Countries

China

Central Contacts

Yan chen, PhD, MD

Role: CONTACT

chenyan72_72@zju.edu.cn

+8613757118653

Shiyuan Lu, PhD

Role: CONTACT

2322135@zju.edu.cn

+8618868110373

Facility Contacts

Yan chen, PhD,MD

Role: primary

chenyan72_72@zju.edu.cn

+8613757118653

Jiang Liu, PhD

Role: primary

Jie Zhong, PhD,MD

Role: primary

jimmyzj64@medmail.com.cn

Yazhen Zhan, MD

Role: primary

References

Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

Reference Type: DERIVED

PMID: 40243391 (View on PubMed)

Other Identifiers

20230049

Identifier Type: -

Identifier Source: org_study_id