Clinical trial NCT03427008: A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Kidney Transplant Recipients
Official title: mDOT: A Pilot Study of Video Directly Observed Therapy for Immunosuppressant Adherence in Adult Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Medication Adherence
Transplant; Kidney
Keywords: mHealth
kidney transplantation
medication adherence
video directly observed therapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppression medication adherence among adult kidney 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 kidney transplant recipients at the Johns Hopkins Hospital.

Detailed description: In adult kidney transplant recipients, the leading predictor of rejection, kidney loss, and death is immunosuppressive medication nonadherence. An estimated one-third of kidney transplant recipients reportedly experience medication nonadherence, and even minor deviations from the required protocol have been shown to have negative effects. However, due to the lack of systematic measurements of adherence, the direct relationship between the level of immunosuppressive medication adherence and poor outcomes is not well understood. Therefore, the investigators believe that mHealth technologies could be a feasible way to allow clinicians and researchers to better understand baseline adherence measurements, and increase immunosuppression adherence among kidney transplant recipients.

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 conduct a randomized control trial to compare medication adherence between patients who use the mHealth system against controls who do not.

Eligibility criteria: Inclusion Criteria:

* Adults (≥22 years)
* Receive a kidney transplant at the Johns Hopkins Hospital

Exclusion Criteria:

* Non-English speaking participants

Primary outcomes:
measure: 12-week immunosuppression medication adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Macey Henderson, JD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Daniel Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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