Novel Mobile Device Application to Improve Adherence
Condition: Pediatric Heart Transplant Recipients; Pediatric Cardiac Transplantation; Pediatric Heart Transplantation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Teen Pocket PATH® Mobile Application; Control Group: Standard of Care
Intervention type(s): Other; Other
Intervention description(s): 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.
Other intervention name(s): TPP mobile app; Mobile health application; Mobile app; cell phone app; Post Heart Transplant Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mobile Application Intervention; Teen Pocket PATH® [TPP]; Adherence; Medical Management