Pediatric Heart Transplantation: Transitioning to Adult Care
TRANSIT
1 other identifier
interventional
88
1 country
6
Brief Summary
The purpose of this pilot trial, Transitioning to Adult Care (TRANSIT), is to develop and test an intervention (i.e., a standardized, tailored transition program focused on enhancing adherence) to improve outcomes for emerging adults who underwent heart transplantation as children and transfer to adult care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
6 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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 5, 2014
CompletedFirst Posted
Study publicly available on registry
March 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedJuly 26, 2017
July 1, 2017
2.3 years
March 5, 2014
July 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants.
Investigators hypothesize that by the end of the 3 month transition program and 6 months of follow-up, 84% of patients will be retained; 80% will participate in the program (module completion, discussion, and follow-up); and 100% will complete at least 80% of the survey instruments at each data collection point.
6 months
Secondary Outcomes (2)
To determine the efficacy of TRANSIT on patient-level outcomes .
6 months
To determine the efficacy of TRANSIT on meso-level outcomes.
6 Months
Study Arms (2)
TRANSIT, behavioral
EXPERIMENTALThe intervention group will receive more guidance during their transition from a pediatric center to the adult center
Usual Care Group
NO INTERVENTIONThe usual care group will receive a standard transfer of care from a pediatric center to an adult center.
Interventions
Eligibility Criteria
You may qualify if:
- Have received a heart transplant at a children's hospital and are ready to transition, as determined by the pediatric heart transplant cardiologist, to the adult heart transplant center with whom a collaborative relationship has been established;
- years or older;
- Able to speak, read at a fifth grade level or above, and write English;
- Physically able to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Loma Linda University
Loma Linda, California, 92354, United States
Universtiy of Colorado Denver/Children Colorado
Aurora, Colorado, 80045, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Columbia University
New York, New York, 10032, United States
Children's Hospital of Philadelphia/University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Elfriede Pahl, MD
Ann and Robert Lurie Children's Hospital
- PRINCIPAL INVESTIGATOR
Kathleen Grady, PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician, Division of Cardiology
Study Record Dates
First Submitted
March 5, 2014
First Posted
March 18, 2014
Study Start
March 1, 2014
Primary Completion
May 31, 2016
Study Completion
May 31, 2017
Last Updated
July 26, 2017
Record last verified: 2017-07