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Completed

NCT Number: NCT02090257

Pediatric Heart Transplantation: Transitioning to Adult Care

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.

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Key information

Conditions

Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University, Loma Linda, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRANSIT

Behavioral

Educational Modules, staff follow up.

Primary outcomes

  1. 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

    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 outcomes

  1. To determine the efficacy of TRANSIT on patient-level outcomes .

    Time frame: 6 months

    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.

  2. To determine the efficacy of TRANSIT on meso-level outcomes.

    Time frame: 6 Months

    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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: TRANSIT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 18, 2014
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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