mDOT for Immunosuppressant Adherence in Adolescent Liver Transplant Recipients

September 17, 2021 updated by: Johns Hopkins University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking
  • International

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mHealth Intervention
Participants will receive the mHealth application either while they are an inpatient post-transplant, or at one of their post-transplant clinic visits. Study personnel will assist participants with downloading the mHealth application and explain its functioning. Participants will then use the application to aid in immunosuppressive medication adherence post-transplant.
Other: mHealth Intervention
The video DOT app will allow transplant recipients to see their medication regimen, record themselves taking every dose, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey
Time Frame: 12 weeks
After 12 weeks in the study, participants will be asked to participate in a semi-structured phone interview in which they will answer questions regarding their medication adherence habits and their thoughts on how our mHealth technology was or was not helpful. They will also complete a 17-question post-satisfaction survey assessing their satisfaction levels with the mhealth technology. Responses in the 17-item survey are on a 7-item Likert scale, ranging from Strongly Agree to Strongly Disagree.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2020

Primary Completion (Actual)

November 12, 2020

Study Completion (Actual)

November 12, 2020

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00177456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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