Feasibility of the "Bring Your Own Device" Model in Clinical Research: Results from a Randomized Controlled Pilot Study of a Mobile Patient Engagement Tool.

BACKGROUND Rising rates of smartphone ownership highlight opportunities for improved mobile application usage in clinical trials. While current methods call for device provisioning, the "bring your own device" (BYOD) model permits participants to use personal phones allowing for improved patient engagement and lowered operational costs. However, more evidence is needed to demonstrate the BYOD model's feasibility in research settings. OBJECTIVE To assess if CentrosHealth, a mobile application designed to support trial compliance, produces different outcomes in medication adherence and application engagement when distributed through study-provisioned devices compared to the BYOD model. METHODS 87 participants were randomly selected to use the mobile application or no intervention for a 28-day pilot study at a 2:1 randomization ratio (2 intervention: 1 control) and asked to consume a twice-daily probiotic supplement. The application users were further randomized into two groups: receiving the application on a personal "BYOD" or study-provided smartphone. In-depth interviews were performed in a randomly-selected subset of the intervention group (five BYOD and five study-provided smartphone users). RESULTS The BYOD subgroup showed significantly greater engagement than study-provided phone users, as shown by higher application use frequency and duration over the study period. The BYOD subgroup also demonstrated a significant effect of engagement on medication adherence for number of application sessions (unstandardized regression coefficient beta=0.0006, p=0.02) and time spent therein (beta=0.00001, p=0.03). Study-provided phone users showed higher initial adherence rates, but greater decline (5.7%) than BYOD users (0.9%) over the study period. In-depth interviews revealed that participants preferred the BYOD model over using study-provided devices. CONCLUSIONS Results indicate that the BYOD model is feasible in health research settings and improves participant experience, calling for further BYOD model validity assessment. Although group differences in medication adherence decline were insignificant, the greater trend of decline in provisioned device users warrants further investigation to determine if trends reach significance over time. Significantly higher application engagement rates and effect of engagement on medication adherence in the BYOD subgroup similarly imply that greater application engagement may correlate to better medication adherence over time.