Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT)

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.

Study Overview

• Status: Completed
• Conditions: Heart Transplantation
• Intervention / Treatment: Behavioral: TRANSIT

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Universtiy of Colorado Denver/Children Colorado
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia/University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRANSIT, behavioral; The intervention group will receive more guidance during their transition from a pediatric center to the adult center	Behavioral: TRANSIT; Educational Modules, staff follow up.
No Intervention: Usual Care Group; The usual care group will receive a standard transfer of care from a pediatric center to an adult center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the efficacy of TRANSIT on patient-level outcomes .	The following patient level outcomes will be measured: At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT will have lower CNI SD (i.e., SD <2.5 for tacrolimus and cyclosporine), than patients who receive usual care.; At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT will have a higher percentage of CNI levels within the target range (i.e., < 50% of CNI blood levels out of target range for individual patients as reported by their transplant center), better self-reported adherence to the medical regimen, and fewer episodes of treated acute rejection, than patients who receive usual care.; At 3 months post intervention and 6 months follow-up, emerging adult heart transplant recipients who participate in TRANSIT then patients who receive usual care.	6 months
To determine the efficacy of TRANSIT on meso-level outcomes.	These will be measured based on the use of health care resources: rates of appointments for clinic and CNI blood draws and number of all-cause days re-hospitalized	6 Months

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Elfriede Pahl, MD, Ann and Robert Lurie Children's Hospital; Principal Investigator: Kathleen Grady, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): May 31, 2016
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Heart transplant recipients who are entering into adult care.
• Other Study ID Numbers: 1R34HL111492 (U.S. NIH Grant/Contract)