Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of patients with a change in their skills at one month or a modification in the management of their disease
研究概览
简要总结
Inflammatory bowel diseases (IBD) are long-term conditions affecting more than 250,000 people in France. They typically begin in young adults and are characterized by flare-ups interspersed with periods of remission. The impact of these diseases goes beyond digestive symptoms, with fatigue present in 50 to 80% of cases. The overall effect on health leads to a decline in quality of life and work productivity. Therapeutic management relies on long-term immunosuppressive treatments aimed at inducing prolonged remission. While therapeutic management has become more complex with an increasing number of available treatments, evaluating the effectiveness and tolerance of these treatments requires a multimodal approach, including therapeutic education and specific follow-up based on the patient's profile and treatment, with the goal of comprehensive care and precision medicine.
Recently, multimodal day hospitalizations have been developed, particularly in response to the recent evolution of treatment administration routes toward subcutaneous or oral forms. In 2022, the gastroenterology and nutrition department of Saint Antoine Hospital, which follows 3,500 patients with CIBD, created a multimodal day hospital (DH) (four interventions) dedicated to patients treated with biologics and Janus kinase inhibitors. In a single session, this approach systematically combines (1) specific biological tests, especially pharmacokinetics, (2) a consultation with a gastroenterologist, (3) a consultation with a therapeutic education nurse, (4) and, depending on the identified needs of the patients, a dietary workshop or fatigue management session; a specialized dermatology or rheumatology consultation; and an ultrasound of the intestinal wall.
The goal of this study is to assess the benefits of a multimodal day hospital on the management and skills of patients with IBD.
详细描述
This is a non-interventional cohort study. Patients will be included over a 6-month period during a scheduled multimodal day hospital visit as part of their care. Before their day hospital appointment, patients will receive an information sheet explaining the research process.
M0 Inclusion:
Patients who agree to participate in the research will receive evaluation questionnaires to be completed online, which include:
- Access to care,
- Adherence according to the self-declared adherence rate,
- Knowledge about their disease (IBDKID2),
- Fatigue (FACIT-F),
- Dietary questionnaire (SLFQ),
- Productivity (WPAI). Patients who do not wish to participate in the study during their visit to the multimodal day hospital will be excluded from the study.
Day of DH:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with ulcerative colitis and Crohn's disease for more than 3 months, with a confirmed diagnosis according to European guidelines, being followed in the gastroenterology department at Saint Antoine Hospital.
- •Aged over 18 years.
- •Undergoing a multimodal day hospital visit, regardless of the scheduled intervention in the gastroenterology department at Saint Antoine Hospital.
- •Not opposed to participating in the research.
排除标准
- •Protective measure in place.
- •Patient who has previously participated in an equivalent day hospital program.
- •Pregnant woman.
结局指标
主要结局
Proportion of patients with a change in their skills at one month or a modification in the management of their disease
时间窗: 1 month
For this study, the benefit of the multimodal Day Hospital (DH) will be evaluated through two groups of criteria: * The criteria of the "Improvement of Patient Skills" group, assessed at the time of day hospitalization and one month later. * The criteria of the "Improvement in Patient Management" group, assessed at the time of day hospitalization. The multimodal DH will be considered beneficial if at least one of these two groups of criteria is met.
次要结局
- self-declared drug adherence rate(1 and 6 month)
- Percentage of patients requiring a treatment discontinuation(1 and 6 month)
- Percentage of patients requiring changes in treatment dosages(1 and 6 month)
- The proportion of patients showing improvement for each individual item.(1 and 6 months)
- The total number of improved criteria per patient.(1 and 6 months)
- The proportion of patients with access to practitioners such as a dietitian specialized in IBD, a rheumatologist, or a dermatologist, outside of the Day Hospital (DH)(1 and 6 months)
- IBD-KID2 score(1 and 6 month)
- SLQF score for SLFQ Dietary Behavior Change(1 and 6 month)
- Change in fatigue behaviors assessed using the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)(1 and 6 month)
- Work Productivity and Activity Impairment Questionnaire in Crohn's disease (WPAI:CD)(1 and 6 month)
- Work Productivity and Activity Impairment Questionnaire in in Ulcerative Colitis (WPAI:UC)(1 and 6 month)