Clinical trial NCT03781830: mDOT for Immunosuppressant Adherence in Adolescent Liver Transplant Recipients
Official title: A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adolescent Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Adherence
Liver Transplantation
Keywords: mHealth
liver transplantation
medication adherence
video directly observed therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single center prospective trial. Participants in this study will use the mHealth application to manage and track their immunosuppression medical regimen post-transplant.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adolescents (14-21 years old)
* Have received a liver transplant at the Johns Hopkins Hospital

Exclusion Criteria:

* Non-English speaking
* International

Primary outcomes:
measure: 12-week immunosuppression adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Macey Henderson, JD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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