A Pilot Study of mDOT for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients

Study Overview
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Brief Summary
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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 kidney transplant recipients. The investigators aim to test this by recruiting adolescent (ages 14-21) kidney 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 50 adolescent kidney transplant recipients at the Johns Hopkins Hospital.

Detailed Description
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In kidney transplant recipients, non-adherence to immunosuppressant medications post-transplant has been associated with a range of negative implications, including increased healthcare utilization, rejection of the graft, kidney loss, and death. Specifically, adolescents and young adults are the most at risk populations for experiencing death-censored graft loss and medication non-adherence. Previous studies have reported rates of non-adherence in this population ranging from 50-70%, and even minor deviations in immunosuppressant medication adherence have been shown to have negative effects. The use of mobile health (mHealth) technology could prove useful in aiding transplant recipients to stay adherent to their medical regimen. 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, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to perform a pilot trial examining the rates of medication adherence in adolescent kidney transplant recipients who use a novel mHealth system, and to understand the acceptability/satisfaction with using this technology.

Official Title
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A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients

Conditions
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Medication Adherence, Kidney Transplant

Intervention / Treatment
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* Other: mHealth Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents (14-21 years old) Have received a kidney transplant at the Johns Hopkins Hospital Exclusion Criteria: Non-English speaking International

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single center prospective control trial. Participants in this study will use the mHealth application to manage and track their immunosuppression medical regimen post-transplant.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth Intervention<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>Participants will not download the mHealth application. They will continue with their standard of care. Study personnel will send out surveys about general adherence. Participants will take their medications according to the instructions given by their transplant team and without any aid of the mHealth application. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-week immunosuppression medication adherence | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, kidney transplantation, medication adherence, video directly observed therapy