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Tailored Transition for IBD Adolescents (TRANSIT)

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ClinicalTrials.gov Identifier: NCT02893670
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Amit Assa, Schneider Children's Medical Center, Israel

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Procedure: Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Re-evaluation for Adolescents With Inflammatory Bowel Disease in Transition (TRANSIT) Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
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

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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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Ages Eligible for Study:   17 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Recent diagnosis (last 6 months)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893670


Contacts
Contact: Amit Assa, MD 972543522211 dr.amit.assa@gmail.com

Locations
Israel
Schenider Children's Medical Center Recruiting
Petaẖ Tiqwa, Israel, 4920235
Contact: Amit Assa, MD    972543522211    dr.amit.assa@gmail.com   
Sponsors and Collaborators
Schneider Children's Medical Center, Israel
Investigators
Study Chair: Raanan Shamir, MD Tel Aviv University

Responsible Party: Amit Assa, Head of IBD program, Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02893670     History of Changes
Other Study ID Numbers: TRANSIT01
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis