A Pilot Study of mDOT for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients
Condition: Medication Adherence; Kidney Transplant
Study type: Interventional

Summary: 
      The investigators are interested in whether or not the use of a mobile health (mHealth)
      application increases the rate of immunosuppression medication adherence among adolescent
      kidney transplant recipients. The investigators aim to test this by recruiting adolescent
      (ages 14-21) kidney transplant recipients to use an mHealth application to record themselves
      taking their immunosuppression medications, and tracking medication adherence over time. The
      study population will be approximately 50 adolescent kidney transplant recipients at the
      Johns Hopkins Hospital.
    

Detailed description: 
      In kidney transplant recipients, non-adherence to immunosuppressant medications
      post-transplant has been associated with a range of negative implications, including
      increased healthcare utilization, rejection of the graft, kidney loss, and death.
      Specifically, adolescents and young adults are the most at risk populations for experiencing
      death-censored graft loss and medication non-adherence. Previous studies have reported rates
      of non-adherence in this population ranging from 50-70%, and even minor deviations in
      immunosuppressant medication adherence have been shown to have negative effects. The use of
      mobile health (mHealth) technology could prove useful in aiding transplant recipients to stay
      adherent to their medical regimen.

      We will use a mobile health platform that enables users to track dose-by-dose medication
      adherence through asynchronous, video directly observed therapy (DOT). This helps patients
      take their medication as prescribed and gives providers the assurance that their patients are
      supported and successful in treatment. DOT is the practice of watching a patient take every
      dose of medicine in-person, and has typically only been done in extreme cases because it can
      be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has
      proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and
      without added burden; emocha's technology allows this through enabling patients to use their
      mobile application to view their regimen, record themselves taking every dose of their
      medication, report side effects or symptoms, visualize their treatment progress, access
      educational content, and track appointments. This information is encrypted and transmitted to
      a HIPAA-secure web portal for providers to review. The aim of this study is to perform a
      pilot trial examining the rates of medication adherence in adolescent kidney transplant
      recipients who use a novel mHealth system, and to understand the acceptability/satisfaction
      with using this technology.
    

Intervention name(s): mHealth Intervention
Intervention type(s): Other
Intervention description(s): The video DOT app will allow transplant recipients to see their medication regimen, record themselves taking every dose, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single center prospective control trial. Participants in this study will use the mHealth application to manage and track their immunosuppression medical regimen post-transplant.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mHealth; kidney transplantation; medication adherence; video directly observed therapy