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NCT Number: NCT05719766

Effect of Incentive Integrated E-IBD Chronic Disease Management Model on 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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

education ,psycological support and social support

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyuan Lu, PhD

CONTACT

[email protected]

+8618868110373

Yan chen, PhD, MD

CONTACT

[email protected]

+8613757118653

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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