mDOT for Immunosuppressant Adherence in Adolescent Liver Transplant Recipients



Status:Not yet recruiting
Healthy:No
Age Range:14 - 21
Updated:2/17/2019
Start Date:March 2019
End Date:July 2021
Contact:Macey 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 Liver 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
liver transplant recipients. The investigators aim to test this by recruiting adolescent
(ages 14-21) liver 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 25 adolescent liver transplant recipients at the Johns
Hopkins Hospital.

Non-adherence to immunosuppressive medications among organ transplant recipients is
associated with a range of short- and long-term complications, and non-adherence is almost 4
times higher in pediatric and adolescent patients compared to adult transplant recipients.
Previous studies have reported rates of non-adherence in this population ranging from 50-70%.
Medication non-adherence in adolescents is associated with increased disease frustration,
poor regimen adaptation/cognitive issues, difficulty with ingestion (e.g., number of
medications, taste), and lack of parental monitoring and involvement. Among pediatric
transplant recipients, psychosocial variables (e.g., psychiatric co-morbidities; child
responsibility for medication) are strong determinants of nonadherence. Medication adherence
is a key concern in the transition from pediatric to adult-centered transplant care, and
transition planning should be prioritized in these transplant patients. Therefore, the
investigators believe that the use of mobile health (mHealth) technology has the potential to
allow clinicians and researchers to better understand nonadherence in pediatric transplant
recipients, and increase immunosuppressive medication adherence.

The investigators 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, and access educational content. This information is encrypted and transmitted to a
HIPAA-secure web portal for providers to review. The aim of this study is to understand
medication adherence in adolescent liver transplant recipients using the mHealth application.

Inclusion Criteria:

- Adolescents (14-21 years old)

- Have received a liver 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
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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