Pediatric Heart Transplantation: Transitioning to Adult Care

NCT ID: NCT02090257

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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TRANSIT, behavioral

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

Group Type EXPERIMENTAL

TRANSIT

Intervention Type BEHAVIORAL

Educational Modules, staff follow up.

Usual Care Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TRANSIT

Educational Modules, staff follow up.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Elfriede Pahl, MD

Attending Physician, Division of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elfriede Pahl, MD

Role: PRINCIPAL_INVESTIGATOR

Ann and Robert Lurie Children's Hospital

Kathleen Grady, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status

Universtiy of Colorado Denver/Children Colorado

Aurora, Colorado, United States

Site Status

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

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Columbia University

New York, New York, United States

Site Status

Children's Hospital of Philadelphia/University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1R34HL111492

Identifier Type: NIH

Identifier Source: org_study_id

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