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CompletedNCT02893670TRANSITUpdated Oct 27, 2022

Tailored Transition for IBD Adolescents

An interventional study of Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation in Inflammatory Bowel Disease, sponsored by Schneider Children's Medical Center, Israel. Completed at 1 site in Israel. Open to participants aged 17 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-10-27.

Sponsored by Schneider Children's Medical Center, Israel · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
17 Years to 18 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Inflammatory Bowel Disease
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In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 70 is close to the median of 70 across 552 interventional studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Schneider Children's Medical Center, Israel is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of inflammatory bowel disease
  2. Age: 17 - 18 years ( inclusive)
  3. Informed consent

Exclusion criteria

Exclusion Criteria:

  1. Recent diagnosis (last 6 months)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    Tailored re-evaluation

    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

    Procedure: Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation

Interventions

  • ProcedureRadiologic (MRE) or endoscopic (sigmoidoscopy) evaluation

    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.

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What researchers measure

Primary outcomes

  1. Change in therapeutic regimen as a result tailored clinical re-evaluation at the end of the transition process

    Time frame: 6 months following enrollment

Secondary outcomes

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

    Time frame: 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

    Time frame: 12 months following transition

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

    Time frame: 12 months following transition

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

    Time frame: 12 months following transition

  5. Surgical rate during the first year following transition

    Time frame: 12 months following transition

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Study locations

1 site
  • Schenider Children's Medical Center
    Petaẖ Tiqwa, 4920235, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02893670
Lead sponsor
Schneider Children's Medical Center, Israel
Responsible party
Amit Assa (Head of IBD program, Schneider Children's Medical Center, Israel) — Principal investigator
First posted
Sep 8, 2016
Start date
Mar 1, 2017
Primary completion
Sep 1, 2021
Completion
Sep 1, 2022
Last update
Oct 27, 2022

Study contacts

Raanan Shamir, MD
study chair · Tel Aviv University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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