Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT07167186
- Status
- Not Yet Recruiting
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Conditions
- Crohn Disease
- Inflammatory Bowel Disease (IBD)
- Ulcerative Colitis (Disorder)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- First listed
- Sep 11, 2025
- Start date
- Sep 30, 2025
- Status verified
- Aug 2025
- Primary completion
- Feb 28, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 240 participants (estimated)
Primary Outcome Measure
Proportion of patients with a change in their skills at one month or a modification in the management of their disease [ Time Frame: 1 month ]
Central Contacts
- Paul Mclellan, Doctor00 33 149283161
- Julien Kirchgesner, Doctor0033 149283162
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