Pediatric Heart Transplantation: Transitioning to Adult Care

NCT02090257 | Completed Results DMC

• 2 other identifiers: 1R34HL111492HL111492
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 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.

Conditions

Heart Transplantation

Keywords

Heart transplant recipients transition to adult care

Outcome Measures

Primary Outcomes (1)

• Number of Participants Adhering With the Transition Program

  Investigators hypothesize that by the end of the 3 month transition program, subjects will be assessed and retained through 6 months of follow-up, and 84% of patients will be retained with 6 month follow-up reported and 80% will participate in the program to full completion (module completion, discussion, and follow-up).

  6 months post transition follow-up

Secondary Outcomes (3)

• Tacrolimus Levels

  6 months post transition follow-up

• Meso-level Outcomes.

  6 Months post transition follow-up

• Percentage of Subjects Reaching a Targeted Tacrolimus Level

  at 6 months post transition followup

Study Arms (2)

TRANSIT, behavioral

EXPERIMENTAL

The intervention group will receive more guidance during their transition from a pediatric center to the adult center

Behavioral: TRANSIT

Usual Care Group

NO INTERVENTION

The usual care group will receive a standard transfer of care from a pediatric center to an adult center.

Interventions

TRANSIT BEHAVIORAL

Educational Modules, staff follow up.

TRANSIT, behavioral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (6)

Loma Linda University

Loma Linda, California, 92354, United States

Location

Universtiy of Colorado Denver/Children Colorado

Aurora, Colorado, 80045, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Children's Hospital of Philadelphia/University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (54)

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Limitations and Caveats

Our pilot trial was limited by small sample size and short duration of follow-up. Also, our population was fairly homogeneous . Additionally, readiness to transfer care to a partner adult HT program was subjective ,which may have introduced bias .

Results Point of Contact

• Title: Elfriede Pahl
• Organization: Ann & Robert H Lurie Childrens Hospital of Chicago

epahl@luriechildrens.org

312-227-4100

Study Officials

• Elfriede Pahl, MD

  Ann and Robert Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

• Kathleen Grady, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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: September 2, 2026
• Results First Posted: September 2, 2026

Record last verified: 2026-08

Locations

US (6)