Inflammatory Bowel DiseaseTRANSITNCT02893670
Tailored Transition for IBD Adolescents
A study testing Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation in people with Inflammatory Bowel Disease, run by Schneider Children's Medical Center, Israel at 1 site in Israel.
Trial summary
Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel diseases (IBD) to adult care is necessary in order to secure continues clinical management and to prevent possible deleterious clinical and psychosocial implications. Read more about this study
- Who is it for?
- Ages 17 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of inflammatory bowel disease
- Age: 17 - 18 years ( inclusive)
- Informed consent
Who cannot join
- 1. Recent diagnosis (last 6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Re-evaluation for Adolescents With Inflammatory Bowel Disease in Transition (TRANSIT) Trial
Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel diseases (IBD) to adult care is necessary in order to secure continues clinical management and to prevent possible deleterious clinical and psychosocial implications. In recent years there is an emphasis on successful transition, however, there are no standardized models or consensus guidelines incorporating both clinical and psychosocial aspects of transition. Objectives: To examine the effect a comprehensive clinical and psychosocial transition package on clinical management and patients outcomes in adolescents with IBD. Design: A prospective, trans-sectional study. Setting: The Schneider Children's Medical Center and the Rabin Medical Center. Participants: Children 17 year to 18 years who are diagnosed with IBD and are planned to initiate transition process to adult care. Main outcome measures: Change in clinical management as a result of tailored re-evaluation as a part of tailored transition package. Secondary outcome measures: a. The effect of a tailored transition package on patients' self-efficacy perception and readiness for transition. b. The effect of a tailored transition package on patient's outcomes (disease activity, flares, hospitalizations) during the first year following transition.
Read the detailed description
General intervention scheme:
Patients with an established diagnosis of IBD (crohn's disease, ulcerative colitis or IBD-unclassified) will be enrolled between the age of 17 and 17.5 years. Patients are eligible for enrollment 6 months following diagnosis and onward.
Following enrollment each patient will undergo a structured re-evaluation as follows:
Each patient will be thoroughly examined and have height ,weight, body mass index performed as well as comprehensive laboratory examinations. Fecal sample for fecal calprotectin will be obtained as well. Extent of disease will be registered using the Montreal classification. Disease activity indices will be calculated according to the Harvey-Bradshaw Index (HBI) for crohn's and Partial Mayo Score (PMS) for UC.
Serum of patients treated with biologic medications will be analyzed for drug trough levels and anti-drug antibodies. Patients treated with thiopurines will have their blood analyzed for thiopurines metabolites. Patients will complete a "self-efficacy" and Transition Readiness Assessment Questionnaire (TRAQ). Both questionnaires were linguistically validated by bi-directional translation. Patients diagnosed with ileal or ileo-colonic crohn's will undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's colitis will undergo a flexible sigmoidoscopy. Flexible sigmoidoscopy was recently shown to have a high degree of correlation with complete colonoscopy in assessments of UC activity.
Treating physicians are entitled to offer the patient a more extensive endoscopic evaluation (complete colonoscopy, gastroscopy) or radiologic evaluation (pelvic MRI, liver ultra-sound) if deemed necessary according to clinical indications.
Following the completion of clinical, laboratory and endoscopic/imaging evaluation a re-evaluation visit with both treating pediatric gastroenterologist and receiving adult gastroenterologist will be set. During this visit physicians will discuss the current treatment plan with the patient and the need for changes in therapeutic regimens (including step-up, step-down, adding or withdrawing optional treatments).
A transition visit with both treating gastroenterologists will be set 3-6 months following the re-evaluation visit (around 18 years of age) in order to assess the efficacy of the therapeutic plan and to complete the transition process. During the transition visit patients will, again, complete a "self-efficacy" and TRAQ questionnaires. In between the reevaluation visit and the transition visit the patients will be followed according to clinical indications by the treating pediatric gastroenterologist.
Prior to the transition visit each patient and parents will perform a transition preparation meeting with a multi-disciplinary team including a pediatric IBD nurse, an adult IBD nurse and a social worker. During this meeting the team will discuss practical issues concerning transition, instruct the patient on subjects specifically related to disease implications during late adolescence and early adulthood (substance abuse, alcohol, contraceptives, pregnancy, high education, work) and address special psycho-social needs/concerns. According to the team discretion, if a need for a meeting with the institute's psychologist is necessary, such meeting will be set within 30 days.
At 12 months following transition data on disease activity and outcomes including flares, hospitalizations and surgical interventions since transition will be collected. Data will be compared with an "historic" cohort of matched patients (case-controlled) who completed routine transition in the time period prior to the study in which transition was performed following 1-2 visits of the patient with both pediatric and adult gastroenterologists.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluationProcedure or surgery
All patients will be assessed for drug levels and metabolites. Patients diagnosed with ileal or ileo-colonic crohn's will undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's colitis will undergo a flexible sigmoidoscopy.
Following re-evaluation each patient will undergo 2 transition meetings with pediatric and adult gastroenterologist as well as a meeting with IBD nurses and social worker.
| Study group | Role | What they receive |
|---|---|---|
| Tailored re-evaluation | Other | Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation:
Following enrollment each patient will undergo a structured re-evaluation and transition process which will include radiologic intervention (MRE) for Crohn's patients and endoscopic intervention (sigmoidoscopy) for UC patients Receives: Procedure: Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in therapeutic regimen as a result tailored clinical re-evaluation at the end of the transition process
Measured: 6 months following enrollment
Secondary outcomes (5)
The change in "self-efficacy" score at the end of the transition process
Measured: 6 months following enrollment
Disease activity (evaluated by crohn's disease activity index for crohn's and Mayo Clinic Index of Activity for UC) at 12 months following transition
Measured: 12 months following transition
The rate of flares during the first year following transition
Measured: 12 months following transition
The rate of hospitalizations during the first year following transition
Measured: 12 months following transition
Surgical rate during the first year following transition
Measured: 12 months following transition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start1 Mar 2017
- Primary completion1 Sep 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schneider Children's Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Assa, Schneider Children's Medical Center, Israel
- Investigators
- Raanan Shamir, MD, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893670
- Sponsor's protocol ID
- TRANSIT01
- Acronym
- TRANSIT
- Status last verified
- Oct 2022
- First submitted
- 30 Aug 2016
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Re-evaluation for Adolescents With Inflammatory Bowel Disease in Transition (TRANSIT) Trial
- ClinicalTrials.gov ID
- NCT02893670
- Acronym / sponsor ID
- TRANSIT / TRANSIT01
- Conditions
- Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Schneider Children's Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel diseases (IBD) to adult care is necessary in order to secure continues clinical management and to prevent possible deleterious clinical and psychosocial implications. In recent years there is an emphasis on successful transition, however, there are no standardized models or consensus guidelines incorporating both clinical and psychosocial aspects of transition. Objectives: To examine the effect a comprehensive clinical and psychosocial transition package on clinical management and patients outcomes in adolescents with IBD. Design: A prospective, trans-sectional study. Setting: The Schneider Children's Medical Center and the Rabin Medical Center. Participants: Children 17 year to 18 years who are diagnosed with IBD and are planned to initiate transition process to adult care. Main outcome measures: Change in clinical management as a result of tailored re-evaluation as a part of tailored transition package. Secondary outcome measures: a. The effect of a tailored transition package on patients' self-efficacy perception and readiness for transition. b. The effect of a tailored transition package on patient's outcomes (disease activity, flares, hospitalizations) during the first year following transition.
Detailed description
General intervention scheme:
Patients with an established diagnosis of IBD (crohn's disease, ulcerative colitis or IBD-unclassified) will be enrolled between the age of 17 and 17.5 years. Patients are eligible for enrollment 6 months following diagnosis and onward.
Following enrollment each patient will undergo a structured re-evaluation as follows:
Each patient will be thoroughly examined and have height ,weight, body mass index performed as well as comprehensive laboratory examinations. Fecal sample for fecal calprotectin will be obtained as well. Extent of disease will be registered using the Montreal classification. Disease activity indices will be calculated according to the Harvey-Bradshaw Index (HBI) for crohn's and Partial Mayo Score (PMS) for UC.
Serum of patients treated with biologic medications will be analyzed for drug trough levels and anti-drug antibodies. Patients treated with thiopurines will have their blood analyzed for thiopurines metabolites. Patients will complete a "self-efficacy" and Transition Readiness Assessment Questionnaire (TRAQ). Both questionnaires were linguistically validated by bi-directional translation. Patients diagnosed with ileal or ileo-colonic crohn's will undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's colitis will undergo a flexible sigmoidoscopy. Flexible sigmoidoscopy was recently shown to have a high degree of correlation with complete colonoscopy in assessments of UC activity.
Treating physicians are entitled to offer the patient a more extensive endoscopic evaluation (complete colonoscopy, gastroscopy) or radiologic evaluation (pelvic MRI, liver ultra-sound) if deemed necessary according to clinical indications.
Following the completion of clinical, laboratory and endoscopic/imaging evaluation a re-evaluation visit with both treating pediatric gastroenterologist and receiving adult gastroenterologist will be set. During this visit physicians will discuss the current treatment plan with the patient and the need for changes in therapeutic regimens (including step-up, step-down, adding or withdrawing optional treatments).
A transition visit with both treating gastroenterologists will be set 3-6 months following the re-evaluation visit (around 18 years of age) in order to assess the efficacy of the therapeutic plan and to complete the transition process. During the transition visit patients will, again, complete a "self-efficacy" and TRAQ questionnaires. In between the reevaluation visit and the transition visit the patients will be followed according to clinical indications by the treating pediatric gastroenterologist.
Prior to the transition visit each patient and parents will perform a transition preparation meeting with a multi-disciplinary team including a pediatric IBD nurse, an adult IBD nurse and a social worker. During this meeting the team will discuss practical issues concerning transition, instruct the patient on subjects specifically related to disease implications during late adolescence and early adulthood (substance abuse, alcohol, contraceptives, pregnancy, high education, work) and address special psycho-social needs/concerns. According to the team discretion, if a need for a meeting with the institute's psychologist is necessary, such meeting will be set within 30 days.
At 12 months following transition data on disease activity and outcomes including flares, hospitalizations and surgical interventions since transition will be collected. Data will be compared with an "historic" cohort of matched patients (case-controlled) who completed routine transition in the time period prior to the study in which transition was performed following 1-2 visits of the patient with both pediatric and adult gastroenterologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored re-evaluation | Other | Procedure: Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluationRadiologic (MRE) or endoscopic (sigmoidoscopy) evaluation: Following enrollment each patient will undergo a structured re-evaluation and transition process which will include radiologic intervention (MRE) for Crohn's patients and endoscopic intervention (sigmoidoscopy) for UC patients |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of inflammatory bowel disease
- Age: 17 - 18 years ( inclusive)
- Informed consent
Key exclusion criteria (1 listed)
- 1. Recent diagnosis (last 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluationAll patients will be assessed for drug levels and metabolites. Patients diagnosed with ileal or ileo-colonic crohn's will undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's colitis will undergo a flexible sigmoidoscopy. Following re-evaluation each patient will undergo 2 transition meetings with pediatric and adult gastroenterologist as well as a meeting with IBD nurses and social worker. | Procedure or surgery | Tailored re-evaluation |
Primary outcome
Change in therapeutic regimen as a result tailored clinical re-evaluation at the end of the transition process
Time frame: 6 months following enrollment
5 secondary outcomes
The change in "self-efficacy" score at the end of the transition process
Time frame: 6 months following enrollment
Disease activity (evaluated by crohn's disease activity index for crohn's and Mayo Clinic Index of Activity for UC) at 12 months following transition
Time frame: 12 months following transition
The rate of flares during the first year following transition
Time frame: 12 months following transition
The rate of hospitalizations during the first year following transition
Time frame: 12 months following transition
Surgical rate during the first year following transition
Time frame: 12 months following transition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Raanan Shamir, MD study chair
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation in people with Inflammatory Bowel Disease, run by Schneider Children's Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 27 Oct 2022. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in therapeutic regimen as a result tailored clinical re-evaluation at the end of the transition process (time frame: 6 months following enrollment). 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 27 Oct 2022.