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A Study of mDOT for Immunosuppressant Adherence in Solid Organ 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: NCT04587024
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : December 2, 2020
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
In solid organ transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection (needing a new transplant), post-transplant complications, and increased healthcare costs. Additionally, nonadherence to immunosuppressant medications is imperative to short- and long-term outcomes. The rate of nonadherence in this population varies vastly. Because of lacking objective and accurate nonadherence measurements, both to immunosuppressant drugs and medical indications, the true implications and prevalence of nonadherence is not yet well understood. Therefore, investigators believe that mobile health (mHealth) technology has the potential to allow clinicians and researchers to more comprehensively address and understand nonadherence in solid organ transplant recipients. The aim of this study is to conduct a randomized control trial to compare medication adherence among liver and kidney transplant patients who use the mHealth system against controls who do not.

Condition or disease Intervention/treatment Phase
Medication Adherence Liver Transplantation Kidney Transplantation Other: mHealth intervention Other: standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Other
Official Title: A Pilot Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
mHealth intervention
mHealth intervention
Other: mHealth intervention
Subjects will receive mHealth direct observation of therapy for 12 weeks

Placebo Comparator: standard of care
post-transplant standard of care
Other: standard of care
Subjects will receive standard of care observation for 12 weeks

Primary Outcome Measures :
  1. Medication Adherence via Medication Level Variability Index (MLVI) [ Time Frame: 12 months ]
    To compare medication adherence of solid organ transplant recipients, specifically liver and kidney transplants, using the mobile DOT (mDOT) application (i.e., intervention) to those who did not use the mDOT application (i.e., control). We will compare medication adherence between intervention and control arms using the Medication Level Variability Index (MLVI), a validated measure of adherence derived from the standard deviation of measured drug levels. We will look at the difference in MLVIs between the two solid organ transplant groups.

Secondary Outcome Measures :
  1. Blood tacrolimus levels [ Time Frame: 12 months ]
    Clinical endpoint measuring the blood levels of tacrolimus (in ng/ml) that indicate rejection of transplant or not

  2. Patient Reported Adherence [ Time Frame: 12 months ]
    Patient reported adherence depending on their scores from the immunosuppressant therapy instrument (ITAS questionnaire) will be measured. This is a binary measure where A stands for 0% none, B stands for 1%-20%, C stands for 21-50%, D stands for greater than 50%.

  3. Patient Reported QoL as assessed by the PedsQL [ Time Frame: 12 months ]
    Patient-reported QoL outcomes as measured by PedsQL to measure quality of life and medication adherence. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).

  4. mHealth Usability Measurement [ Time Frame: 3 months ]
    Patient-reported usability measured using the Post-Study System Usability Questionnaire (PSSUQ), a 16-item questionnaire with score range of 1 to 16 with higher score indicating better usability. This will be done in the mHealth intervention arm only

  5. Patterns of Medication Adherence [ Time Frame: 12 months ]
    To examine the patterns of medication adherence in transplant recipients in both groups to better understand baseline medication adherence. We will be doing this by looking at the adherence streaks (number of doses taken over number of doses expected).

  6. Provider workflow as assessed by patient usage of the mDOT app [ Time Frame: 12 months ]
    Provider clinical workflow will be measured by evaluating patient usage on the app.

  7. Patient Reported QoL as assessed by the SF-36 [ Time Frame: 12 months ]
    Patient Reported QoL Short Form (SF)-36 to measure quality of life and medication adherence. The scoring is scaled at 0 as the lowest and 100 as the highest. The lower the score, the more disability.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Participants must meet all of the following inclusion criteria to participate in this study:

> 13 years old Own a smart phone and are willing to receive information through it Received a liver or kidney transplant at a participating study site during or prior to the study period.

Exclusion Criteria:

All candidates meeting any of the following exclusion criteria at baseline will be excluded from study participation:

Patients with cognitive impairments will not be eligible for enrollment due to inability to provide informed consent.

Inability or unwillingness of individual or legal guardian/representative to give consent.

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): NCT04587024

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Contact: Naureen Islam 410-955-9161
Contact: Abigail Shegelman

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United States, Florida
University of Miami Not yet recruiting
Miami, Florida, United States, 33136
Contact: Lissett Moni   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Naureen Islam   
Contact: Abigail Shegelman   
United States, Virginia
University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22903
Contact: Robin Kelly   
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Douglas Mogul, MD, PhD Johns Hopkins University
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Responsible Party: Johns Hopkins University Identifier: NCT04587024    
Other Study ID Numbers: IRB00257447
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: October 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