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

NCT07167186 | Not Yet Recruiting

• 2 other identifiers: APHP 240469IDRCB: 2024-A00870-47
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease (IBD); Crohn Disease; Ulcerative Colitis (Disorder)

Keywords

Therapeutic education; Inflammatory bowel disease; Crohn's disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 month

Secondary Outcomes (11)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 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 and eligible for a multimodal day hospital

You may qualify if:

• 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.

You may not qualify if:

• Protective measure in place.
• Patient who has previously participated in an equivalent day hospital program.
• Pregnant woman.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de gastroentérologie Hôpital Saint Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Paul Mclellan, Doctor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Mclellan, Doctor

CONTACT

00 33 149283161; paul.mclellan@aphp.fr

Julien Kirchgesner, Doctor

CONTACT

0033 149283162; julien.kirchgesner@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: September 11, 2025
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)