A Pilot Study of mDOT for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients



Status:Not yet recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:14 - 21
Updated:2/14/2019
Start Date:March 2019
End Date:July 1, 2021
Contact:Macey L Henderson, JD PhD
Email:macey@jhmi.edu
Phone:443-287-6649

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A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients

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.

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.

Inclusion Criteria:

- Adolescents (14-21 years old)

- Have received a kidney transplant at the Johns Hopkins Hospital

Exclusion Criteria:

- Non-English speaking

- International
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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