Heart Transplantation
Conditions
Keywords
Heart transplant recipients transition to adult care
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.
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.
Interventions
BEHAVIORALTRANSIT
Educational Modules, staff follow up.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Adhering With the Transition Program | 6 months post transition follow-up | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tacrolimus Levels | 6 months post transition follow-up | 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. |
| Meso-level Outcomes. | 6 Months post transition follow-up | 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 |
| Percentage of Subjects Reaching a Targeted Tacrolimus Level | at 6 months post transition followup | Percentage of subjects in each group who met target tacro level |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElfriede Pahl, MD
Ann and Robert Lurie Children's Hospital
PRINCIPAL_INVESTIGATORKathleen Grady, PhD
Northwestern University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants |
| Age, Continuous | 21.4 years STANDARD_DEVIATION 3.25 |
| education bachelors degree | 3 Participants |
| education high school grad | 13 Participants |
| education some college | 27 Participants |
| education some high school/technical school | 12 Participants |
| employment not working | 26 Participants |
| employment working for income-yes | 17 Participants |
| marital status married/partner | 7 Participants |
| marital status single | 81 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 41 |
| other Total, other adverse events | 5 / 37 | 0 / 41 |
| serious Total, serious adverse events | 8 / 37 | 4 / 41 |
Outcome results
None listed