Inflammatory Bowel Disease (IBD)AMBUMICNCT07167186
Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)
An observational study of Inflammatory Bowel Disease (IBD) and Crohn Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn Disease, Ulcerative Colitis (Disorder)
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Protective measure in place.
- Patient who has previously participated in an equivalent day hospital program.
- Pregnant woman.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de gastroentérologie Hôpital Saint Antoine
Paris, 75012
Paul Mclellan, Doctor, 00 33 149283161,, paul.mclellan@aphp.fr
Julien Kirchgesner, Doctor, 0033 149283161, julien.kirchgesner@aphp.fr
About this study
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.
Read the 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.
- Keywords
- Therapeutic education, Inflammatory bowel disease, Crohn's disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (11)
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.
Measured: 1 and 6 month
Percentage of patients requiring a treatment discontinuation
Measured: 1 and 6 month
Percentage of patients requiring changes in treatment dosages
Measured: 1 and 6 month
The proportion of patients showing improvement for each individual item.
Measured: 1 and 6 months
The total number of improved criteria per patient.
Measured: 1 and 6 months
The proportion of patients with access to practitioners such as a dietitian specialized in IBD, a rheumatologist, or a dermatologist, outside of the Day Hospital (DH)
Measured: 1 and 6 months
IBD-KID2 score
Understanding of disease and treatment based on the IBD-KID2 (inflammatory bowel disease knowledge inventory device) score, comprising 13 questions An absolute increase in score of 3 units will be considered a significant improvement
Measured: 1 and 6 month
SLQF score for SLFQ Dietary Behavior Change
Patients are categorized into four knowledge categories: insufficient, problematic, sufficient, or excellent, based on respective scores of 0-25, 25-33, 33-42, and 42-50. Any move to a higher category will be considered a significant improvement.
Measured: 1 and 6 month
Change in fatigue behaviors assessed using the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)
An absolute increase in score of 4 units will be considered a significant improvement
Measured: 1 and 6 month
Work Productivity and Activity Impairment Questionnaire in Crohn's disease (WPAI:CD)
Change in work effectiveness behaviors assessed by the Work Productivity and Activity Impairment Questionnaire in Crohn's disease (WPAI:CD) An absolute increase in score of 20 units will be considered a significant improvement.
Measured: 1 and 6 month
Work Productivity and Activity Impairment Questionnaire in in Ulcerative Colitis (WPAI:UC)
Change in work Productivity and Activity Impairment Questionnaire in Ulcerative Colitis (WPAI:UC) An absolute increase in score of 20 units will be considered a significant improvement.
Measured: 1 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Mclellan, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167186
- Sponsor's protocol ID
- APHP 240469
- Other IDs
- IDRCB: 2024-A00870-47
- Acronym
- AMBUMIC
- Status last verified
- Aug 2025
- First submitted
- 9 Jun 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The questionnaires will be completed directly by the patients using an electronic platform accessible via the Internet (e-CRF Cleanweb - Telemedicine SA, with the "ePro" feature), developed by URCEST in collaboration with the coordinating investigator. This method of data collection was chosen to facilitate the completion process and streamline the questionnaire flow. A report of anonymized aggregated data at the end of the study will be published. No individual participant data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multimodal Day Hospital for the Overall Management of Patients With Chronic Inflammatory Bowel Diseases (IBD)
- ClinicalTrials.gov ID
- NCT07167186
- Acronym / sponsor ID
- AMBUMIC / APHP 240469
- Keywords
- Therapeutic education, Inflammatory bowel disease, Crohn's disease, Ulcerative colitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Protective measure in place.
- Patient who has previously participated in an equivalent day hospital program.
- Pregnant woman.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
11 secondary outcomes
self-declared drug adherence rate
Time frame: 1 and 6 month
Percentage of patients requiring a treatment discontinuation
Time frame: 1 and 6 month
Percentage of patients requiring changes in treatment dosages
Time frame: 1 and 6 month
The proportion of patients showing improvement for each individual item.
Time frame: 1 and 6 months
The total number of improved criteria per patient.
Time frame: 1 and 6 months
The proportion of patients with access to practitioners such as a dietitian specialized in IBD, a rheumatologist, or a dermatologist, outside of the Day Hospital (DH)
Time frame: 1 and 6 months
IBD-KID2 score
Time frame: 1 and 6 month
SLQF score for SLFQ Dietary Behavior Change
Time frame: 1 and 6 month
Change in fatigue behaviors assessed using the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: 1 and 6 month
Work Productivity and Activity Impairment Questionnaire in Crohn's disease (WPAI:CD)
Time frame: 1 and 6 month
Work Productivity and Activity Impairment Questionnaire in in Ulcerative Colitis (WPAI:UC)
Time frame: 1 and 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. The questionnaires will be completed directly by the patients using an electronic platform accessible via the Internet (e-CRF Cleanweb - Telemedicine SA, with the "ePro" feature), developed by URCEST in collaboration with the coordinating investigator. This method of data collection was chosen to facilitate the completion process and streamline the questionnaire flow. A report of anonymized aggregated data at the end of the study will be published. No individual participant data will be available.
Related trials for Inflammatory Bowel Disease (IBD)
Not yet recruitingPhase 1
Safety, Tolerability and Pharmacokinetics of ICP-B161 in Healthy Adults Volunteers
Inflammatory Bowel Disease(IBD)
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Not yet recruitingObservational study
Biophysical Assessments of Acupuncture Points in Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD)
RecruitingObservational study
Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
RecruitingObservational study
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
Inflammatory Bowel Disease (IBD), Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Mclellan, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Crohn Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Mclellan, Doctor (00 33 149283161, paul.mclellan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.