Study Stopped
problems with subject accrual
Transition of Inflammatory Bowel Disease (IBD) Patients From Pediatric to Adult Gastroenterologist (GI)
Improving the Transition of Care From Pediatric GI to Adult GI for Patients With IBD: A Prospective Randomized Trial of a New Model
1 other identifier
interventional
28
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2006
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedApril 4, 2017
April 1, 2017
4.5 years
August 2, 2006
April 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease IBD flare at 1 year
1 year
Study Arms (2)
Joint Visits
EXPERIMENTALTransition patients will have 2 joint visits performed with the pediatric GI specialist and the adult GI specialist as they transfer care to an adult GI provider.
Control
NO INTERVENTIONTransition patients in the control group will transfer care to adult GI provider in typical manner.
Interventions
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.
Eligibility Criteria
You may qualify if:
- A patient may be considered for study participation if all of the following apply:
- Outpatient of either sex aged ≥ 16 years or older.
- The patient has a confirmed diagnosis of IBD.
- No plans to move \> 200 miles from Nashville in the subsequent 12 months.
- 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.
You may not qualify if:
- The patients will be excluded from the study if one or more of the following apply:
- Unable to give consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Vanderbilt Clinic
Nashville, Tennessee, 37232-5280, United States
Vanderbilt Childrens Hospital/ Pediatric Gastroenterology Clinic
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Schwartz, M.D.
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 3, 2006
Study Start
August 1, 2006
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 4, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share