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A Pilot Study of mDOT for Immunosuppressant Adherence in Adult 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: NCT03515330
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : July 2, 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 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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single center, prospective, randomized control trial with two arms. Participants in the intervention arm will use the mHealth app to manage and track their immunosuppression medical regimen post-transplant, and participants in the control arm will receive the current standard of follow-up care post-transplant.
Masking: Single (Outcomes Assessor)
Masking Description: Patients will be aware of which arm they are randomized to; thus, the study will not be blinded to practitioners or patients. However, study personnel performing data analysis will receive de-identified data that does not explicitly describe which group is intervention and which is control, but simply the code without a key. Only the PI and necessary personnel performing data extraction will have the key for the code to minimize bias in data analysis.
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adult Liver Transplant Recipients
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Standard of Care
Participants in the control arm will be instructed to take their immunosuppressant medications as prescribed and attend required follow-up as is standard of care, and will not receive the mHealth application.
Experimental: mHealth Intervention
Participants in the intervention arm will receive the mHealth app either while they are an inpatient post-transplant, or at their first post-transplant clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the application and explain its functioning. Participants will then use the application to aid in immunosuppressant medication adherence post-transplant.
Other: mHealth Intervention
The mHealth application will allow liver transplant recipients to see their medication regimen, record a video of themselves taking every dose, 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.

Primary Outcome Measures :
  1. 12-week immunosuppression medication 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.

  2. Alcohol Craving Assessment [ Time Frame: 12 weeks ]
    As abstaining from alcohol is important following liver transplantation, we will administer a daily question through the mDOT app asking about alcohol craving and use. Patients who screen positive for alcohol craving and or use through the daily in-app question will be referred to a transplant social worker who will administer the Alcohol Craving Questionnaire Short Form.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT03515330

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Contact: Macey Henderson, JD, PhD 443-287-6649

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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Macey Henderson, JD, PhD    443-287-6649   
Contact: Dorry Segev, MD, PhD    443-287-4510   
Principal Investigator: Macey L Henderson, JD, PhD         
Principal Investigator: Andrew Cameron, MD, PhD         
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Macey Henderson, JD, PhD Johns Hopkins University
Principal Investigator: Andrew Cameron, MD, PhD Johns Hopkins University
Singleton, E.G., Tiffany, S.T. & Henningfield, J.E. (2000). Alcohol Craving Questionnaire (ACQ-NOW): Background, Scoring, and Administration (Manual). Baltimore, MD: Intramural Research Program, National Institute on Drug Abuse.

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Responsible Party: Johns Hopkins University Identifier: NCT03515330    
Other Study ID Numbers: IRB00173000
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 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