A Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients

Conditions
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Medication Adherence, Liver Transplantation, Kidney Transplantation

Intervention / Treatment
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* Other: mHealth intervention
* Other: standard of care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: mHealth intervention<br>mHealth intervention | Other: mHealth intervention<br>* Subjects will receive mHealth direct observation of therapy for 12 weeks<br>|
| Placebo Comparator: standard of care<br>post-transplant standard of care | Other: standard of care<br>* Subjects will receive standard of care observation for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence via Medication Level Variability Index (MLVI) | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood tacrolimus levels | Clinical endpoint measuring the blood levels of tacrolimus (in ng/ml) that indicate rejection of transplant or not | 12 months | 
| Patient Reported Adherence | 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%. | 12 months | 
| Patient Reported QoL as assessed by the PedsQL | 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). | 12 months | 
| mHealth Usability Measurement | 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 | 3 months | 
| Patterns of Medication Adherence | 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). | 12 months | 
| Provider workflow as assessed by patient usage of the mDOT app | Provider clinical workflow will be measured by evaluating patient usage on the app. | 12 months | 
| Patient Reported QoL as assessed by the SF-36 | 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. | 12 months |