Pediatric Heart Transplantation Clinical Trial
Official title:
Randomized, Controlled Trial of a Novel Mobile Device Application to Improve Adherence in Children Greater Than 11 Years of Age After Cardiac Transplantation (CTOTC-10)
The purpose of this study is to collect and compare information on how and when adolescent heart transplant recipients take their prescribed medication. The investigators want to find out if regular use of 'an app' on cell phones, called the Teen Pocket PATH® (TPP), can help adolescents take their medication according to their prescribed dosing schedule. This may then help reduce complications of transplant, such as rejection. The investigators also want to find out if how adolescent heart transplant recipients take their medications affects the development of antibodies in their blood. Antibodies are small proteins in the blood that may develop after heart transplantation, and which can sometimes damage a new heart.
This is a multi-center, randomized, open label clinical trial of a novel mobile application.
The intervention in this randomized controlled trial is the provision of a novel mobile
health application (Teen Pocket PATH® [TPP]). Participants will include heart recipients
11-17 years of age transplanted at one of the listed study sites (refer to Contacts and
Locations Section of this ClinicalTrials.gov record).
It is important that heart transplant recipients take their prescribed heart transplant
medication. One of the challenges for adolescent (children ages 11 to 17) heart transplant
recipients is being able to follow their medication dosing schedule consistently. The purpose
of this study is to collect and compare information on how and when adolescent heart
transplant recipients take their prescribed medications. The investigators want to find out
if regular use of 'an app' on the participant's cell phone, called the Teen Pocket PATH®
(TPP), can help adolescent heart transplant recipients take their medication according to
their prescribed dosing schedule. This may then help reduce complications of transplant, such
as rejection. The investigators also want to evaluate whether how one takes their medications
affects the development of antibodies in their blood. Antibodies are small proteins in the
blood that may develop after heart transplantation, and which can sometimes damage a
recipient's new heart.
The TPP app provides reminders to the participant and their parent/guardian, includes a list
of their medications, and maintains a log to help track medication taking. The parent(s) will
receive a text message when their participating child enters into the TPP app that s/he has
taken his/her medication. The parent(s) will also be notified via text if their participating
adolescent child does not enter information into the TPP app regarding their medication
adherence and related timing information. The information collected on the TTP app will be
available to the study investigators.
Eligible participants will be randomly selected (randomized) to be in one of two groups: this
means that each participant will have an equal but random chance of being assigned to:
- the Experimental Group - participants will receive standard of care and use the TPP app
to monitor how they take their medication or
- the Control Group - participants will receive standard of care and will not not receive
the TPP app.
Both groups will have the same number of scheduled research visits and will receive the usual
treatment and medication provided by their doctor for their heart transplant. Research visits
will coincide with your routine clinic visits.
The study will not change the care that participants receive prior to, during or after
transplantation. The study will collect information about participants, their medication
dosing schedule, and their medical condition and care. In addition, the investigators will
collect some blood at certain times for research. This blood will be used to measure
antibodies in the blood.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02752789 -
Impact of Allo- and Autoantibodies on Chronic Cardiac Allograft Function
|
||
| Active, not recruiting |
NCT03386539 -
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
|
Phase 3 | |
| Completed |
NCT01005316 -
Allo-Antibodies in Pediatric Heart Transplantation
|
N/A |