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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Schenider Children's Medical Center

    Petah Tikva, 4920235

Other trials in Israel

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.

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 groups in NCT02893670
Study groupRoleWhat they receive
Tailored re-evaluationOtherRadiologic (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.

  1. 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)
  1. The change in "self-efficacy" score at the end of the transition process

    Measured: 6 months following enrollment

  2. 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

  3. The rate of flares during the first year following transition

    Measured: 12 months following transition

  4. The rate of hospitalizations during the first year following transition

    Measured: 12 months following transition

  5. 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.

  1. First posted8 Sep 2016 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion1 Sep 2021
  4. Study completion1 Sep 2022

Resources

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)
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

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.

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