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Starting soon Observational

Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)

NCT07167186 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-09
Last updated
2025-09-11

Condition(s) studied

Inflammatory Bowel Disease (IBD)Crohn DiseaseUlcerative Colitis (Disorder)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Protective measure in place. * Patient who has previously participated in an equivalent day hospital program. * Pregnant woman.

Primary outcome measure(s)

  • Proportion of patients with a change in their skills at one month or a modification in the management of their disease — 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.

Trial sites (1)

FacilityCityRegionStatus
Service de gastroentérologie Hôpital Saint Antoine Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07167186 on ClinicalTrials.gov ↗ ← All trials in France