A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Liver Transplant Recipients
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 3/24/2019 |
| Start Date: | April 2019 |
| End Date: | June 2020 |
| Contact: | Macey Henderson, JD, PhD |
| Email: | macey@jhmi.edu |
| Phone: | 443-287-6649 |
A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adult Liver Transplant Recipients
The investigators are interested in whether or not the use of a mobile health (mHealth)
application increases the rate of immunosuppressant medication adherence among adult liver
transplant recipients. The investigators aim to test this by randomly assigning transplant
recipients to the intervention (use of an mHealth app to manage and track their
immunosuppression regimen) or control arm (standard of care) upon discharge from their
initial transplant hospitalization, and tracking medication adherence over time. The study
population will be approximately 50 adult liver transplant recipients at the Johns Hopkins
Hospital.
application increases the rate of immunosuppressant medication adherence among adult liver
transplant recipients. The investigators aim to test this by randomly assigning transplant
recipients to the intervention (use of an mHealth app to manage and track their
immunosuppression regimen) or control arm (standard of care) upon discharge from their
initial transplant hospitalization, and tracking medication adherence over time. The study
population will be approximately 50 adult liver transplant recipients at the Johns Hopkins
Hospital.
In adult transplant recipients, poor adherence to immunosuppressant medications carries the
risk of graft rejection, post-transplant complications, and increased healthcare costs. In
adult liver transplant recipients, adherence to immunosuppressant drugs, as well as to
general medical indications (e.g. avoiding alcohol intake), is imperative to short- and
long-term outcomes. The rate of non-adherence to immunosuppressant medications in this
population varies vastly, with reports ranging from 15-40%. Because of lacking objective and
accurate non-adherence measurements, the true implications and prevalence of non-adherence is
not yet well understood. Therefore, the investigators believe that mobile health (mHealth)
technology has the potential to allow clinicians and researchers to more comprehensively
address and understand non-adherence in adult liver transplant recipients. Additionally, an
mHealth application with the ability to track symptoms, side effects, and alcohol cravings
could provide clinicians with valuable information on post-transplant care.
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, 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 conduct a randomized control
trial to compare medication adherence between patients who use the mHealth application
against controls who do not.
risk of graft rejection, post-transplant complications, and increased healthcare costs. In
adult liver transplant recipients, adherence to immunosuppressant drugs, as well as to
general medical indications (e.g. avoiding alcohol intake), is imperative to short- and
long-term outcomes. The rate of non-adherence to immunosuppressant medications in this
population varies vastly, with reports ranging from 15-40%. Because of lacking objective and
accurate non-adherence measurements, the true implications and prevalence of non-adherence is
not yet well understood. Therefore, the investigators believe that mobile health (mHealth)
technology has the potential to allow clinicians and researchers to more comprehensively
address and understand non-adherence in adult liver transplant recipients. Additionally, an
mHealth application with the ability to track symptoms, side effects, and alcohol cravings
could provide clinicians with valuable information on post-transplant care.
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, 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 conduct a randomized control
trial to compare medication adherence between patients who use the mHealth application
against controls who do not.
Inclusion Criteria:
- Greater than or equal to 22 years of age
- Receive a liver transplant at Johns Hopkins Hospital
Exclusion Criteria:
- Non-English speaking liver transplant recipients
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Macey L Henderson, JD, PhD
Phone: 443-287-6649
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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