Viewing Study NCT00360022



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Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00360022
Status: TERMINATED
Last Update Posted: 2017-04-04
First Post: 2006-08-02

Brief Title: Transition of Inflammatory Bowel Disease IBD Patients From Pediatric to Adult Gastroenterologist GI
Sponsor: Vanderbilt University Medical Center
Organization: Vanderbilt University Medical Center

Study Overview

Official Title: Improving the Transition of Care From Pediatric GI to Adult GI for Patients With IBD A Prospective Randomized Trial of a New Model
Status: TERMINATED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: problems with subject accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine if the program that has been made to ease the transition of care for adolescent patients with IBD from pediatric gastroenterology to adult gastroenterology is effective to reduce the risk of disease flare during this period Patient satisfaction with this program will also be assessed
Detailed Description: Approximately 15 to 25 of patients with inflammatory bowel disease are diagnosed prior to the age of 18 The chronic course of this disease means that approximately one quarter of all IBD patients will need to transition from being cared for by a pediatric gastroenterologist to an adult gastroenterologist Studies in other chronic disease states have identified several problems with the current means of transitioning care from a pediatrician to the adult caregiver including lack of adherence with the proposed treatment lack of knowledge about the disease and limited self-care skills Even without IBD this can be a time of tremendous turmoil for the adolescent patient For the chronically ill IBD patient this stress is further intensified by the underlying illness Several studies have shown that the risk of flare is increased by non-adherence with medical treatment The main factors associated with poor adherence include young age and either being under the doctors care for less than one year or being a new patient for that doctor Therefore young adults transferring care from a pediatric gastroenterologist to an adult gastroenterologist are at the highest risk for a bad outcome

Several recommendations have been published on how to best transition the adolescent IBD patient from pediatric to adult care The general consensus is that there should be a gradual age specific increase in patient autonomy and involvement in their care prior to being transitioned to an adult gastroenterologist No study however has incorporated combined clinic visits for the patient with both the pediatric and adult IBD specialist Furthermore although these recommendations make logical sense they have not been assessed objectively

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None