232.1: Mobile directly observed therapy for immunosuppression adherence in adult kidney transplant recipients: A pilot randomized controlled trial.

Abstract

Background: The leading predictor of rejection, de novo DSA, graft loss, and death among adult kidney transplant (KT) recipients is immunosuppressive medication nonadherence. An estimated one-third of kidney transplant recipients reportedly experience medication nonadherence. To understand if mobile technology with asynchronous, video directly observed therapy can be leveraged in adult KT recipients to improve medication adherence habits, we adapted a mobile smartphone application (mDOT) that has previously been shown to increase medication adherence among tuberculous patients. This protocol has been reviewed and approved by the applicable institutional review boards with respect to scientific content and compliance with applicable research and human subjects regulations. Methods: We are testing the feasibility of implementing mDOT for transplantation in a pilot randomized control trial (RCT). Key features of mDOT for transplantation include a HIPAA-compliant patient-facing smartphone app and transplant provider-facing web portal, symptom and side-effect tracking and reporting, dose-by dose medication tracking with video observation by transplant pharmacy capability, text message and push notifications for medication reminders, and two-way in-app secure messaging between patient and provider. Our ongoing pilot RCT (NCT03427008) is evaluating mDOT on rates of post-transplant immunosuppression medication adherence in adult KT recipients in preparation for a fully-powered multi-site clinical trial. Participants are randomized to the intervention (mDOT) or control arm (standard of care) using block randomization. Immunosuppression adherence is tracked over time through medical record abstraction of laboratory values in addition to the self-reported immunosuppressant therapy adherence instrument. Qualitative feedback on the feasibility and usability of mDOT for transplantation is collected from patients through a telephone interview and post-satisfaction survey at the end of their 12-weeks in the study (Figure). Results: We have enrolled 10 adult KT recipients as of October 2018. 50% of the patients identify as white and 50% as black. 70% of these patients are male and median age is 57.5 (IQR: 45.0, 61.0) (Table). Feedback from patients and video reviewers have allowed us to optimize the app to foster greater patient-provider communication and user-friendliness. Clinical outcomes and qualitative feedback will be available at the time of ISODP. Conclusions: Designed to facilitate immunosuppression adherence and engagement with transplant providers, mDOT may be a promising technology for adult KT recipients in the early post-transplant period. National Institute of Diabetes and Digestive and Kidney Diseases K01DK114388. National Institute of Diabetes and Digestive and Kidney Diseases K24DK101828. National Institute of Diabetes and Digestive and Kidney Diseases K01DK101677. Johns Hopkins University Discovery Award.