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mDOT for Immunosuppressant Adherence in Adolescent Liver Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03781830
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Medication Adherence Liver Transplantation Other: mHealth Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adolescent Liver Transplant Recipients
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking
  • International

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03781830

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Contact: Macey Henderson, JD, PhD 443-287-6649
Contact: Douglas Mogul, MD, MPH 410-955-8769

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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Macey Henderson, JD, Phd Johns Hopkins University


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Responsible Party: Johns Hopkins University Identifier: NCT03781830    
Other Study ID Numbers: IRB00177456
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
liver transplantation
medication adherence
video directly observed therapy
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs