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Clinical Trials/NCT03781830
NCT03781830
Withdrawn
N/A

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

Johns Hopkins University1 site in 1 countryJune 18, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Johns Hopkins University
Locations
1
Primary Endpoint
12-week immunosuppression adherence
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 18, 2020
End Date
November 12, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

12-week immunosuppression adherence

Time Frame: 12 weeks

After 12 weeks in the study, patients will complete the 4-item immunosuppressant therapy adherence instrument (ITAS) to determine self-reported medication adherence (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression level trends will be tracked via electronic medical record review to determine medication adherence.

Secondary Outcomes

  • Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey(12 weeks)

Study Sites (1)

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