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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Improved score of Quality of Life after three months [Срок оценки: three months]

Вторичные конечные точки (3)

• Decreased score of Socially activity limited rating [Срок оценки: three months,one year]
• Decreased score of Hospital Anxiety and Depression Scale [Срок оценки: three months,one year]
• Increasion of disease kownledge [Срок оценки: three months,one year]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 4 центра

• Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliate — Ханчжоу
• Department of Gastroenterology, Huzhou Central Hospital — Huzhou
• Department of Gastroenterology, Ruijin Hospital — Шанхай
• Department of Gastroenterology, Shaoxing Central Hospital — Shaoxing

Публикации

• 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. PMID 40243391

Идентификаторы

NCT: NCT05719766 · 20230049

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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