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A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Liver Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03515330
Recruitment Status : Not yet recruiting
First Posted : May 3, 2018
Last Update Posted : November 29, 2018
Sponsor:
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.


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
Estimated Study Start Date : February 7, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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. 1-month immunosuppression medication adherence [ Time Frame: 1 month ]
    Patients in both arms will be surveyed and complete the 4-item immunosuppressant therapy instrument (ITAS) (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression lab values will be tracked to determine medication adherence.

  2. 3-month immunosuppression medication adherence [ Time Frame: 3 months ]
    Patients in both arms will be surveyed and complete the 4-item ITAS (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression lab values will be tracked to determine medication adherence.

  3. 6-month immunosuppression medication adherence [ Time Frame: 6 months ]
    Patients in both arms will be surveyed and complete the 4-item ITAS (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression lab values will be tracked to determine medication adherence.


Secondary Outcome Measures :
  1. 1-month Alcohol Craving Assessment [ Time Frame: 1 month ]
    Participants in both arms will take the Alcohol Craving Questionnaire Short Form to measure multidimensional acute alcohol cravings. The scale measures four dimensions (subscales) of alcohol craving labeled Emotionality, Purposefulness, Compulsivity, and Expectancy.

  2. 3-month Alcohol Craving Assessment [ Time Frame: 3 months ]
    Participants in both arms will take the Alcohol Craving Questionnaire Short Form to measure multidimensional acute alcohol cravings. The scale measures four dimensions (subscales) of alcohol craving labeled Emotionality, Purposefulness, Compulsivity, and Expectancy.

  3. 6-month Alcohol Craving Assessment [ Time Frame: 6 months ]
    Participants in both arms will take the Alcohol Craving Questionnaire Short Form to measure multidimensional acute alcohol cravings. The scale measures four dimensions (subscales) of alcohol craving labeled Emotionality, Purposefulness, Compulsivity, and Expectancy.



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT03515330


Contacts
Contact: Macey Henderson, JD, PhD 443-287-6649 macey@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Macey Henderson, JD, PhD    443-287-6649    macey@jhmi.edu   
Contact: Dorry Segev, MD, PhD    443-287-4510    dorry@jhmi.edu   
Principal Investigator: Macey L Henderson, JD, PhD         
Principal Investigator: Andrew Cameron, MD, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Macey Henderson, JD, PhD Johns Hopkins University
Principal Investigator: Andrew Cameron, MD, PhD Johns Hopkins University

Publications:
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.

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03515330     History of Changes
Other Study ID Numbers: IRB00173000
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
mHealth
liver transplantation
medication adherence
video directly observed therapy

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs