Tailored Transition for IBD Adolescents

NCT02893670 | Completed DMC

• 1 other identifier: TRANSIT01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

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

  6 months following enrollment

Secondary Outcomes (5)

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

  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

  12 months following transition

• The rate of flares during the first year following transition

  12 months following transition

• The rate of hospitalizations during the first year following transition

  12 months following transition

• Surgical rate during the first year following transition

  12 months following transition

Study Arms (1)

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

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

Interventions

Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation PROCEDURE

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.

Tailored re-evaluation

Eligibility Criteria

• Age: 17 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of inflammatory bowel disease
• Age: 17 - 18 years ( inclusive)
• Informed consent

You may not qualify if:

• \. Recent diagnosis (last 6 months)

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schenider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

X-Rays; Sigmoidoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Raanan Shamir, MD

  Tel Aviv University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IBD program

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 8, 2016
• Study Start: March 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)