mKidney: A novel mobile health application to improve follow-up and post-donation care management in living kidney donors

Background: Living kidney donors face a small but measurable increase in the risk of developing chronic diseases, including end‐stage renal disease, after donation. The Organ Procurement and Transplantation Network (OPTN) requires that transplant hospitals monitor donors at 6‐months, 1‐year, and 2‐years postdonation; however, the majority of transplant programs struggle to meet these requirements.1 Mobile health (mHealth) technologies have shown promise in promoting patient engagement and self‐care management in other healthcare settings. An mHealth system might improve transplant hospitals' ability to engage with donors in postdonation follow‐up care and achieve compliance with OPTN‐mandated reporting requirements. Methods: We developed the mKidney® system based on input elicited from donors, transplant providers, and thought leaders in the field of transplantation and health information technology. We are conducting a pilot randomized controlled trial (RCT) to evaluate the impact of the mKidney® system on rates of postdonation follow‐up, in preparation for a fully‐powered multi‐site clinical trial (NCT03400085). Participants are randomized to the intervention (mKidney ® system) or control arm (standard of care) using block randomization. Compliance with follow‐up at 6‐months, 1‐year, and 2‐years is tracked over time. 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. Results: Extensive stakeholder input resulted in key design features of the mKidney® system, including a HIPAA‐compliant patient‐facing smartphone app and transplant provider‐facing web portal, simple user interface for answering required clinical survey questions and reviewing responses, automated short message service (SMS) text message reminders, email and push notifications, as well as data export functionality. We have enrolled 164 donors as of April 2019; more clinical outcomes will be available at the time of ISODP. Conclusions: Designed specifically to facilitate the required collection and reporting of donor follow‐up data, the mKidney® system is a possible new solution to improve historically poor post‐donation follow‐up and care management.