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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Protective measure in place.

Patient who has previously participated in an equivalent day hospital program.

Pregnant woman.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
1 month

Secondary outcomes

1

self-declared drug adherence rate

Evaluation of skill-related criteria at the 6-month mark self-declared drug adherence rate: scale from 0 to 100 A threshold below 80% defines non-compliant patients. A relative increase of 20% will be considered a significant improvement.

Time frame
1 and 6 month
2

Percentage of patients requiring a treatment discontinuation

Time frame
1 and 6 month
3

Percentage of patients requiring changes in treatment dosages

Time frame
1 and 6 month
4

The proportion of patients showing improvement for each individual item.

Time frame
1 and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: