Strategic Planning and Execution
An international food manufacturer offering a line-up of well-known brands under the liquid condiment category planned to drive growth by introducing its legacy rice vinegar brand as an intervention to lower blood pressure in pre-hypertensive adults and those with an increased risk of CVD. ObvioHealth was tasked with developing a research plan to test the product against a placebo iteration to determine safety, efficacy, and likeability amongst consumers. Enrollment for the study required a diverse population (60-70 percent Caucasian, 10-30 percent African-American, 10-20 percent “other race”). Two sites were chosen within the Houston, Texas and Atlanta, Georgia areas to aid in the enrollment efforts.
ObvioHealth managed all aspects of study execution from protocol & eCRF design, recruitment, randomization, subject management, logistics, and integration of a product shipping partner. ClaimIt was deployed in a hybrid study model amongst two U.S. sites designed to collect clinical safety and efficacy data utilizing vascular function reactivity testing and laboratory testing as a method to measure and monitor the subjects’ cardiovascular health. Between site visits, subjects completed daily questionnaires and chatted with the study team via the ClaimIt app. Subjects also received daily reminders from the app to drink the product as well as report any changes to their health status to the study team. This kept participants engaged, compliant and retained.
A digital recruitment strategy was deployed to rapidly enroll 130 pre-hypertensive subjects, resulting in an unprecedented number of African American subjects enrolled. Nine days after the launch of the study, the first subject was randomized. The use of the ClaimIt app with the mix of site visits afforded a very high product-compliance rate of 93 percent. ObvioHealth utilized highly advanced technology to track vital clinical results for this project and facilitated the collection of all data points for real-time evaluation by our biostatisticians. The final data is still being evaluated.
ObvioHealth enrolled 130 subjects from Georgia and Texas in 170 days for a fraction of the recruitment cost of a traditional “brick and mortar” site.
ObvioHealth screened 5,057 subjects, but due to specific protocol criteria, many did not qualify. Due to specific protocol criteria, ObvioHealth knew it needed to screen a large number of potential participants