Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Kidney Transplant
  • Medication Adherence
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 14 years and 21 years
Gender
Both males and females

Description

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 mo...

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.

Tracking Information

NCT #
NCT03504137
Collaborators
Not Provided
Investigators
Principal Investigator: Macey L Henderson, JD PhD Johns Hopkins University