Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elfriede Pahl, MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT02090257
First received: March 5, 2014
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Heart Transplantation
Behavioral: TRANSIT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Pediatric Heart Transplantation: Transitioning to Adult Care

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • To determine the efficacy of TRANSIT on patient-level outcomes . [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    The following patient level outcomes will be measured:

    1. 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.
    2. 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.
    3. 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.

  • To determine the efficacy of TRANSIT on meso-level outcomes. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT02090257

Contacts
Contact: Elfriede Pahl, MD epahl@luriechildrens.org
Contact: Kathleen Grady, PhD kgrady@nmh.org

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Elfriede Pahl, MD Ann and Robert Lurie Children's Hospital
Principal Investigator: Kathleen Grady, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Elfriede Pahl, MD, Attending Physician, Division of Cardiology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02090257     History of Changes
Other Study ID Numbers: 1R34HL111492
Study First Received: March 5, 2014
Last Updated: April 14, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Heart transplant recipients who are entering into adult care.

ClinicalTrials.gov processed this record on October 01, 2014