Trial Outcomes & Findings for Pediatric Heart Transplantation: Transitioning to Adult Care (NCT NCT02090257)
NCT ID: NCT02090257
Last Updated: 2026-09-02
Results Overview
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).
COMPLETED
NA
88 participants
6 months post transition follow-up
2026-09-02
Participant Flow
Participant milestones
| Measure |
TRANSIT, Behavioral
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
45
|
|
Overall Study
COMPLETED
|
37
|
41
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Heart Transplantation: Transitioning to Adult Care
Baseline characteristics by cohort
| Measure |
TRANSIT, Behavioral
n=43 Participants
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: Educational Modules, staff follow up.
|
Usual Care Group
n=45 Participants
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=136 Participants
|
45 Participants
n=136 Participants
|
88 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 3.2 • n=136 Participants
|
21.5 years
STANDARD_DEVIATION 3.3 • n=136 Participants
|
21.4 years
STANDARD_DEVIATION 3.25 • n=272 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=136 Participants
|
22 Participants
n=136 Participants
|
41 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=136 Participants
|
23 Participants
n=136 Participants
|
47 Participants
n=272 Participants
|
|
education
some high school/technical school
|
5 Participants
n=136 Participants
|
7 Participants
n=136 Participants
|
12 Participants
n=272 Participants
|
|
education
high school grad
|
13 Participants
n=136 Participants
|
8 Participants
n=136 Participants
|
21 Participants
n=272 Participants
|
|
education
some college
|
22 Participants
n=136 Participants
|
27 Participants
n=136 Participants
|
49 Participants
n=272 Participants
|
|
education
bachelors degree
|
3 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
6 Participants
n=272 Participants
|
|
marital status
married/partner
|
5 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
7 Participants
n=272 Participants
|
|
marital status
single
|
38 Participants
n=136 Participants
|
43 Participants
n=136 Participants
|
81 Participants
n=272 Participants
|
|
employment
working for income-yes
|
17 Participants
n=136 Participants
|
26 Participants
n=136 Participants
|
43 Participants
n=272 Participants
|
|
employment
not working
|
26 Participants
n=136 Participants
|
19 Participants
n=136 Participants
|
45 Participants
n=272 Participants
|
PRIMARY outcome
Timeframe: 6 months post transition follow-upInvestigators 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).
Outcome measures
| Measure |
Usual Care Group
n=45 Participants
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
|
TRANSIT, Behavioral
n=43 Participants
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: Educational Modules, staff follow up.
|
|---|---|---|
|
Number of Participants Adhering With the Transition Program
|
41 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 6 months post transition follow-upThe 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.
Outcome measures
| Measure |
Usual Care Group
n=45 Participants
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
|
TRANSIT, Behavioral
n=43 Participants
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: Educational Modules, staff follow up.
|
|---|---|---|
|
Tacrolimus Levels
|
6.0 ng/dl
Standard Deviation 1.4
|
6.0 ng/dl
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 6 Months post transition follow-upThe 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
Outcome measures
| Measure |
Usual Care Group
n=41 Participants
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
|
TRANSIT, Behavioral
n=37 Participants
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: Educational Modules, staff follow up.
|
|---|---|---|
|
Meso-level Outcomes.
Clinic attendance through 6 months
|
38 Participants
|
33 Participants
|
|
Meso-level Outcomes.
CNI appt adherence through 6 months
|
32 Participants
|
25 Participants
|
|
Meso-level Outcomes.
All-cause rehospitalizations through 6 months
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: at 6 months post transition followupPercentage of subjects in each group who met target tacro level
Outcome measures
| Measure |
Usual Care Group
n=45 Participants
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
|
TRANSIT, Behavioral
n=43 Participants
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: Educational Modules, staff follow up.
|
|---|---|---|
|
Percentage of Subjects Reaching a Targeted Tacrolimus Level
|
57 percentage of subjects
|
75 percentage of subjects
|
Adverse Events
TRANSIT, Behavioral
Usual Care Group
Serious adverse events
| Measure |
TRANSIT, Behavioral
n=37 participants at risk
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: Educational Modules, staff follow up.
|
Usual Care Group
n=41 participants at risk
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
|
|---|---|---|
|
General disorders
hospitalization
|
21.6%
8/37 • Number of events 8 • Events were captured through 6 months followup visit, which was when the study was concluded. Adverse events included all hospitalizations, rejection episodes which were treated, infections, and death.
|
9.8%
4/41 • Number of events 4 • Events were captured through 6 months followup visit, which was when the study was concluded. Adverse events included all hospitalizations, rejection episodes which were treated, infections, and death.
|
Other adverse events
| Measure |
TRANSIT, Behavioral
n=37 participants at risk
The intervention group will receive more guidance during their transition from a pediatric center to the adult center
TRANSIT: Educational Modules, staff follow up.
|
Usual Care Group
n=41 participants at risk
The usual care group will receive a standard transfer of care from a pediatric center to an adult center.
|
|---|---|---|
|
Cardiac disorders
treated rejection
|
13.5%
5/37 • Number of events 5 • Events were captured through 6 months followup visit, which was when the study was concluded. Adverse events included all hospitalizations, rejection episodes which were treated, infections, and death.
|
0.00%
0/41 • Events were captured through 6 months followup visit, which was when the study was concluded. Adverse events included all hospitalizations, rejection episodes which were treated, infections, and death.
|
Additional Information
Elfriede Pahl
Ann & Robert H Lurie Childrens Hospital of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place