The Kidney Mobile Health Registry Pilot Study

Abstract

Background: Mobile health (mHealth) can offer investigators novel approaches to research and data collection, while reducing traditional barriers to study participation. Potential benefits to research use of mHealth include representative sample acquisition of rare disease participants, access to external electronic health record (EHR) data, and real-time disease metric tracking. Unfortunately, mHealth initiatives in kidney disease research are limited. Objective: Assess the feasibility and potential value of mHealth use in targeted kidney disease study populations including integration into existing traditional clinical studies through a pilot of the Kidney Mobile Health Registry. Methods: Three ongoing, observational cohort studies (Recurrence post-transplant observational study in FSGS and Minimal Change Disease (RESOLVE), Kidney Research Network (KRN), and Cure Glomerulonephropathy Network (CureGN) were selected as pilot sub-studies for the Kidney Mobile Health Registry. The registry was built in collaboration with CareEvolution (Ann Arbor, MI) and is offered via the MyDataHelps (MDH) application (iOS, Android, or web). Individuals were invited to participate in the registry by the study team or could enroll independently via weblink or QR code. Target enrollment was uncapped including both children and adults with glomerular diseases. Participants were consented electronically within the platform and prompted to connect to their local EHR system(s) upon enrollment. Additional patient reported information was collected through in-app surveys. Results: The sub-studies were moved to production following a phased approach. Prior to production launch, beta testing was completed. Feedback regarding system bugs, usability, and suggestions for improvement were provided and implemented in an iterative fashion. All phases of the mobile registry were moved to production by March 2024. Thus far 13 patients have been enrolled across the 3 pilots, primarily in CureGN. EHR data extracted for the initial 11 CureGN patients have been validated against existing laboratory data available to the study team with 96% accuracy for the study's 2 most important endpoints (creatinine and urine protein to creatinine ratio UPCR). Further, the initial data extract yielded an additional 137 creatinine values and 162 UPCR values not previously available. Pilot survey results suggest favorable reactions to use and utility of mHealth in ongoing kidney disease studies. Conclusions: Our pilot data suggests that mHealth has the potential to offer significant value to kidney health research where there is significant need for innovation. Our EHR results suggest significant opportunity to prolong follow up times with important kidney outcomes in a remote fashion regardless of clinical site IT infrastructure and reduce clinical coordinator burden. Further exploration of mHealth for recruitment, retention, and participant engagement strategies specific to the glomerular disease and larger kidney disease populations are needed.