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Heart TransplantationTRANSITNCT02090257

Pediatric Heart Transplantation: Transitioning to Adult Care

A study testing TRANSIT in people with Heart Transplantation, run by Ann & Robert H Lurie Children's Hospital of Chicago at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Transplantation
What is being tested?
TRANSIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
6 sitesUnited States
Study dates
1 Mar 2014to 31 May 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Universtiy of Colorado Denver/Children Colorado

    Aurora, Colorado, 80045

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

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Loma Linda University

    Loma Linda, California, 92354

  • Columbia University

    New York, New York, 10032

  • Children's Hospital of Philadelphia/University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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.

Read the detailed description

Young adult heart transplant (HT) recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine feasibility and test a transition intervention for young adults who underwent HT as children and transferred to adult care.

Participants were randomized to the transition intervention (4 months long, focused on HT knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models.

Being tested
TRANSIT
Keywords
Heart transplant recipients transition to adult care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRANSITBehavioural

    Educational Modules, staff follow up.

Study groups in NCT02090257
Study groupRoleWhat they receive
TRANSIT, behavioralExperimentalThe intervention group will receive more guidance during their transition from a pediatric center to the adult center
Receives: Behavioral: TRANSIT
Usual Care GroupNo interventionThe usual care group will receive a standard transfer of care from a pediatric center to an adult center.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months post transition follow-up

Secondary outcomes (3)

  1. Tacrolimus Levels

    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(calcineurin inhibitor) SD (standard deviation) (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.

    Measured: 6 months post transition follow-up

  2. Meso-level Outcomes.

    The 3 meso level outcomes which were measured are the following (clinical appointment adherence and re-hospitalization). These are measured through

    1. # of participants with clinic attendance through 6 months post transition follow up
    2. # of participants with appointment adherence for CNI (calcineurin inhibitor= tacro and cyclosporine) blood draws through 6 months post transition follow up
    3. # of participants with all-cause re-hospitalizations through 6 months post transition follow up

    Measured: 6 Months post transition follow-up

  3. Percentage of Subjects Reaching a Targeted Tacrolimus Level

    Percentage of subjects in each group who met target tacro level

    Measured: at 6 months post transition followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2014 (estimated)
  2. Study start1 Mar 2014
  3. Primary completion31 May 2016
  4. Study completion31 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02090257
Sponsor's protocol ID
1R34HL111492
Other IDs
HL111492
Acronym
TRANSIT
Status last verified
Aug 2026
First submitted
5 Mar 2014
Last updated
2 Sep 2026
Data monitoring committee
Yes

Publications

  • Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.

    PubMed 10842426

  • Bell LE, Sawyer SM. Transition of care to adult services for pediatric solid-organ transplant recipients. Pediatr Clin North Am. 2010 Apr;57(2):593-610, table of contents. doi: 10.1016/j.pcl.2010.01.007.

    PubMed 20371054

  • Keith DS, Cantarovich M, Paraskevas S, Tchervenkov J. Recipient age and risk of chronic allograft nephropathy in primary deceased donor kidney transplant. Transpl Int. 2006 Aug;19(8):649-56. doi: 10.1111/j.1432-2277.2006.00333.x.

    PubMed 16827682

  • Ringewald JM, Gidding SS, Crawford SE, Backer CL, Mavroudis C, Pahl E. Nonadherence is associated with late rejection in pediatric heart transplant recipients. J Pediatr. 2001 Jul;139(1):75-8. doi: 10.1067/mpd.2001.115067.

    PubMed 11445797

  • Foster BJ, Dahhou M, Zhang X, Dharnidharka V, Ng V, Conway J. High Risk of Graft Failure in Emerging Adult Heart Transplant Recipients. Am J Transplant. 2015 Dec;15(12):3185-93. doi: 10.1111/ajt.13386. Epub 2015 Jul 16.

    PubMed 26189336

  • Foster BJ, Dahhou M, Zhang X, Platt RW, Samuel SM, Hanley JA. Association between age and graft failure rates in young kidney transplant recipients. Transplantation. 2011 Dec 15;92(11):1237-43. doi: 10.1097/TP.0b013e31823411d7.

    PubMed 22124283

  • Annunziato RA, Emre S, Shneider B, Barton C, Dugan CA, Shemesh E. Adherence and medical outcomes in pediatric liver transplant recipients who transition to adult services. Pediatr Transplant. 2007 Sep;11(6):608-14. doi: 10.1111/j.1399-3046.2007.00689.x.

    PubMed 17663682

  • Bell LE, Bartosh SM, Davis CL, Dobbels F, Al-Uzri A, Lotstein D, Reiss J, Dharnidharka VR. Adolescent Transition to Adult Care in Solid Organ Transplantation: a consensus conference report. Am J Transplant. 2008 Nov;8(11):2230-42. doi: 10.1111/j.1600-6143.2008.02415.x. Epub 2008 Sep 24.

    PubMed 18822088

  • Fredericks EM. Nonadherence and the transition to adulthood. Liver Transpl. 2009 Nov;15 Suppl 2:S63-9. doi: 10.1002/lt.21892.

    PubMed 19876953

  • McBride ME, Foushee MT, Brown RN, Ewald GA, Canter CE. Outcomes of pediatric heart transplant recipients transitioned to adult care: an exploratory study. J Heart Lung Transplant. 2010 Nov;29(11):1309-10. doi: 10.1016/j.healun.2010.06.005. Epub 2010 Jul 8. No abstract available.

    PubMed 20619681

  • Samuel SM, Nettel-Aguirre A, Hemmelgarn BR, Tonelli MA, Soo A, Clark C, Alexander RT, Foster BJ; Pediatric Renal Outcomes Canada Group. Graft failure and adaptation period to adult healthcare centers in pediatric renal transplant patients. Transplantation. 2011 Jun 27;91(12):1380-5. doi: 10.1097/TP.0b013e31821b2f4b.

    PubMed 21519292

  • LaRosa C, Glah C, Baluarte HJ, Meyers KE. Solid-organ transplantation in childhood: transitioning to adult health care. Pediatrics. 2011 Apr;127(4):742-53. doi: 10.1542/peds.2010-1232. Epub 2011 Mar 7.

    PubMed 21382946

  • Kreuzer M, Prufe J, Oldhafer M, Bethe D, Dierks ML, Muther S, Thumfart J, Hoppe B, Buscher A, Rascher W, Hansen M, Pohl M, Kemper MJ, Drube J, Rieger S, John U, Taylan C, Dittrich K, Hollenbach S, Klaus G, Fehrenbach H, Kranz B, Montoya C, Lange-Sperandio B, Ruckenbrodt B, Billing H, Staude H, Heindl-Rusai K, Brunkhorst R, Pape L. Transitional Care and Adherence of Adolescents and Young Adults After Kidney Transplantation in Germany and Austria: A Binational Observatory Census Within the TRANSNephro Trial. Medicine (Baltimore). 2015 Dec;94(48):e2196. doi: 10.1097/MD.0000000000002196.

    PubMed 26632907

  • Annunziato RA, Arrato N, Rubes M, Arnon R. The importance of mental health monitoring during transfer to adult care settings as examined among paediatric transplant recipients. J Paediatr Child Health. 2015 Feb;51(2):220-2. doi: 10.1111/jpc.12765. Epub 2014 Nov 18.

    PubMed 25407852

  • Morsa M, Gagnayre R, Deccache C, Lombrail P. Factors influencing the transition from pediatric to adult care: A scoping review of the literature to conceptualize a relevant education program. Patient Educ Couns. 2017 Oct;100(10):1796-1806. doi: 10.1016/j.pec.2017.05.024. Epub 2017 May 15.

    PubMed 28528694

Questions about this trial

What is this clinical trial studying?

A study testing TRANSIT in people with Heart Transplantation, run by Ann & Robert H Lurie Children's Hospital of Chicago at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Adhering With the Transition Program (time frame: 6 months post transition follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02090257, which also lists 54 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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