Strategic Planning and Execution
A global leader in carotenoid-based dietary supplements desired to understand the efficacy of one of its supplements in relieving symptoms linked with Lower Urinary Tract Symptoms (LUTS). Accompanying objectives included: Gauging subject satisfaction and perception, measuring probability of continued use and/or recommendation of the product, assessing product safety, and identifying changes in sexual function after completion of treatment cycle.
This study called for male subjects, age 40 or older, residing in the U.S. – who accumulated a score of eight (or greater) on the self-administered International Prostate Symptom Score (I-PSS) questionnaire (used to analyze LUTS). Participants were recruited by way of online advertisements which linked to a landing page explaining both the clinical trial and treatment product in detail. Interested subjects were then invited to access ClaimIt™, ObvioHealth’s application used to conduct studies digitally, where they could review/sign an electronic informed consent (eIC) form before being considered for enrollment. Being a remote study, subjects weren’t required to visit a physical site during screening but were instead asked to fill out a screening and medical history e-questionnaire. After enrollment, subjects were asked to consume one capsule of the manufacturer’s supplement each day for twelve consecutive weeks, and to report any noticeable changes to their health.
Efficacy was proven during the study, as subjects reported the treatment helpful in reducing symptoms of LUTS. ObvioHealth employed a recruiting method that enabled the targeting of subjects on a nation-wide scale, allowing for the collection of data points from across the U.S., as opposed to numerous remote locations. The study was designed to be completely remote, offering convenience to subjects who may have not otherwise been able to participate. Subjects overwhelmingly described the ClaimIt™ application as user-friendly, with over 92 percent of survey respondents describing the app as either “easy” or “very easy” to use; 95 percent of respondents identified ClaimIt™ as “easier to use compared to filling out printed forms on paper.”