Transition Study of Inflammatory Bowel Disease (IBD) Patients From Pediatric Gastroenterologist to Adult Gastroenterologist

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00360022
First received: August 2, 2006
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Inflammatory Bowel Diseases
Crohn's Disease
Ulcerative Colitis
Other: Transition program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Decrease IBD flare at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
Group B transition patients will have 2 joint visits performed with the pediatric GI specialist and the adult GI specialist.
Other: Transition program
Both the pediatric GI specialist and the adult GI specialist will see the patient together at 2 different visits. The first joint visit is lead by the pediatric MD and the second joint visit is lead by the adult MD.
No Intervention: A
Group A is control group who transfer care to adult GI provider in typical manner.

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 doctor's 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient may be considered for study participation if all of the following apply:

  1. Outpatient of either sex aged ≥ 16 years or older.
  2. The patient has a confirmed diagnosis of IBD.
  3. No plans to move > 200 miles from Nashville in the subsequent 12 months.
  4. The patient has read, understood and signed a written informed consent form. Permission of a minor participant will be obtained via a parent consent form.

Exclusion Criteria:

The patients will be excluded from the study if one or more of the following apply:

  1. Unable to give consent.
  2. Does not meet inclusion criteria above.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360022

Contacts
Contact: Tonya F Givens, BSN 615-936-1745 tonya.givens@vanderbilt.edu

Locations
United States, Tennessee
The Vanderbilt Clinic Recruiting
Nashville, Tennessee, United States, 37232-5280
Contact: Tonya F Givens, BSN, RN    615-936-1745    tonya.givens@vanderbilt.edu   
Principal Investigator: David Schwartz, MD         
Vanderbilt Childrens Hospital/ Pediatric Gastroenterology Clinic Recruiting
Nashville, Tennessee, United States, 37232
Contact: Tonya F Givens, BSN, RN    615-936-1745    tonya.givens@vanderbilt.edu   
Sub-Investigator: Dedrick Moulton, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: David A Schwartz, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: David A. Schwartz MD / Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00360022     History of Changes
Other Study ID Numbers: 060580
Study First Received: August 2, 2006
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014