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

NCT ID: NCT07167186

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-07-31

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.

Detailed Description

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:

Upon arrival at the multimodal day hospital, if the questionnaires have not been completed in advance, patients will be offered the opportunity to complete them during their visit, with an estimated duration of 30 minutes.

M1 (4 Weeks Post-DH):

Four weeks after the day hospital visit, patients will receive an email with a link to complete the questionnaires again (adherence, knowledge of their disease, fatigue, dietary questionnaire, and productivity). If the questionnaires are not completed, a reminder email will be sent 3 days and 1 month after the due date. If there is no response, a phone call will be scheduled 1 week after the initially planned date by the clinical research technician. Questionnaires can be filled out up to 8 weeks after inclusion.

M6 (6 Months Post-DH):

Six months after the day hospital visit, patients will again receive an email with a link to complete the questionnaires (adherence, knowledge of their disease, fatigue, dietary questionnaire, and productivity). A reminder email will be sent 3 days and 1 month after the due date if there is no response. If there is still no response, a phone call will be made 1 week after the initially scheduled date by the clinical research technician. Questionnaires can be completed up to 7 months after inclusion.

Between M0 and M1:

Treatment optimization and the update of the vaccination schedule will be recorded in the patient's electronic health record.

Study Participation End:

Participation in the study will conclude after the completion of the questionnaires, no later than 7 months after inclusion Statistical analysis The analysis will be performed using SAS v9.4 software (or a later version) by the URC-Est at the end of the study after the database freeze. A detailed statistical analysis plan will be written before the database freeze. A flow chart will be created.

The patient profile at inclusion will be described, including comorbidities, characteristics of the IBD (such as clinical and biological activity at the time of the day hospital visit), and treatments. The day hospital process will be evaluated, including the number of patients per session and the type of interventions performed.

Qualitative variables will be described by their frequency and count, while quantitative variables will be described by their mean and standard deviation or by their median and interquartile range, depending on their distribution.

Analysis of the Primary Endpoint The proportion of patients with an improvement in their skills at one month or an improvement in the management of their disease will be calculated. The proportion of patients with improvement in each of the two groups of criteria will also be calculated.

Analysis of Secondary Endpoints Secondary endpoints will be measured by the proportion of patients showing improvement for each individual item. The total number of items with improvement per patient will also be evaluated, as well as the proportion of patients with access to practitioners such as a dietitian specialized in IBD, a rheumatologist, or a dermatologist outside the day hospital, based on the dedicated questionnaire.

A logistic regression will be conducted to identify the predictors of improvement in patient skills or disease management, based on patient characteristics, IBD features, and treatments.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Mclellan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de gastroentérologie Hôpital Saint Antoine

Paris, , France

Countries

France

Central Contacts

Paul Mclellan, Doctor

Role: CONTACT

paul.mclellan@aphp.fr

00 33 149283161

Julien Kirchgesner, Doctor

Role: CONTACT

julien.kirchgesner@aphp.fr

0033 149283162

Facility Contacts

Paul Mclellan, Doctor

Role: primary

paul.mclellan@aphp.fr

00 33 149283161,

Julien Kirchgesner, Doctor

Role: backup

julien.kirchgesner@aphp.fr

0033 149283161

Other Identifiers

IDRCB: 2024-A00870-47

Identifier Type: OTHER

Identifier Source: secondary_id

APHP 240469

Identifier Type: -

Identifier Source: org_study_id