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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
26
Participants in the intervention group will receive the mobile application for improving adherence to their post-transplant medications. The intervention will prompt, remind, and warn participants when medications are due, inform parents when medication management is completed, and engage parents when no action is undertaken.
Adolescents and parents/guardians assigned to the Standard Care Condition will receive standard clinical care per standard site procedures.
Emory University School of Medicine: Pediatric Transplantation
Atlanta, Georgia, United States
Boston Children's Hospital: Pediatric Transplantation
Boston, Massachusetts, United States
St. Louis Children's Hospital: Pediatric Transplantation
St Louis, Missouri, United States
Columbia University Medical Center: Pediatric Transplantation
New York, New York, United States
Montefiore Medical Center: Pediatric Transplantation
New York, New York, United States
Children's Hospital of Philadelphia: Pediatric Transplantation
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh: Pediatric Transplantation
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt: Pediatric Transplantation
Nashville, Tennessee, United States
Comparison of Variability in Tacrolimus Levels by Group Assignment
Variability in tacrolimus levels (standard deviation of post discharge first year outpatient tacrolimus levels commencing at 3 months post-transplantation).
Time frame: 3 months ( to 12 Months Post-Transplantation
Count of Rejection Events within the First Year Post-Transplant by Group Assignment
Rejection events will include acute cellular, mixed, and clinical rejection.
Time frame: Within 12 Months Post-Transplantation
Count of Participants that Develop Post-Transplant De Novo Donor Specific Donor-Specific Antibody (DSA) and Autoantibodies by Group Assignment
De novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin.
Time frame: Within12 Months Post-Transplantation
Comparison of Engagement in Self-Care Measured by the Medication Adherence Measure (MAM) by Group Assignment
Engagement in self-care as measured by self-report using the Medication Adherence Measure (MAM).
Time frame: At Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 12 Months (Visit 4) Post-Transplantation
Engagement in Self-Care Measured by TPP Activity
Engagement in self-care during the first year after heart transplantation as measured by the mobile app, Teen Pocket PATH® (TPP).
Time frame: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
Comparison of Self-Reported Medication Adherence by Group Assignment
Self-reported medication adherence assessed using the medication module of the Medication Adherence Measure (MAM). The MAM will be applied at each clinic visit unless within 7 days of prior visit. Scores for all surveys will be averaged over the course of follow-up.
Time frame: Baseline (Visit 1), 3-months (Visit 2), 6 months (Visit 3), and 12 months (Visit 4) Post-Transplantation
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