Pediatric Heart Transplantation: Transitioning to Adult Care

Heart Transplantation Clinical Trial

— TRANSIT  

Official title:

Pediatric Heart Transplantation: Transitioning to Adult Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090257
• Other study ID #: 1R34HL111492
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: July 25, 2017
• Start date: March 1, 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2017
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Behavioral:
• TRANSIT
Educational Modules, staff follow up.

Locations

Country	Name	City	State
United States	Universtiy of Colorado Denver/Children Colorado	Aurora	Colorado
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Loma Linda University	Loma Linda	California
United States	Columbia University	New York	New York
United States	Children's Hospital of Philadelphia/University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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