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Tailored Transition for IBD Adolescents

NCT02893670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-10-27

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Schneider Children's Medical Center, Israel

    lead OTHER

Principal Investigators

  • Raanan Shamir, MD · Tel Aviv University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-09-01
Completion
2022-09-01

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02893670 on ClinicalTrials.gov