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Clinical Trials/NCT02090257
NCT02090257
Completed
Not Applicable

Pediatric Heart Transplantation: Transitioning to Adult Care

Ann & Robert H Lurie Children's Hospital of Chicago6 sites in 1 country88 target enrollmentMarch 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Transplantation
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
88
Locations
6
Primary Endpoint
To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2014
End Date
May 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elfriede Pahl, MD

Attending Physician, Division of Cardiology

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

Inclusion Criteria

  • 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;
  • 18 years or older;
  • Able to speak, read at a fifth grade level or above, and write English;
  • Physically able to participate.

Exclusion Criteria

  • History of psychiatric hospitalization within the last 3 months, assessed on a case-by-case basis with exclusion only if patients could not potentially benefit from the intervention.

Outcomes

Primary Outcomes

To assess the feasibility of TRANSIT by measuring the transition program adherence for those randomized to the intervention and survey completion for all participants.

Time Frame: 6 months

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.

Secondary Outcomes

  • 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 Sites (6)

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