The trial, which included 350 women to validate the efficacy of the device on women’s incontinence, was done completely virtually.
Outsourcing-Pharma caught up with Matty Culbreth-Notaro, Chief Operating Officer of ObvioHealth, and Dan Brenner, founder & CEO of 1nHealth, to find out more.
Outsourcing-Pharma (OSP): Could you please share some perspective on what might make a urogynecology study especially challenging, compared to other conditions or therapeutic areas?
Matty Culbreth-Notaro (MCN): Most urogynecology studies revolve around sensitive topics that, unfortunately, many women find embarrassing. DCTs can minimize site visits where face-to-face conversations about intimate topics can be intimidating. In Renovia’s case, women could participate virtually - without a single site visit - allowing them to be discreet and comfortable.
Women can also be a difficult cohort to recruit. Women are disproportionately responsible for child care and for caring for older loved ones while also working. This leaves them little time to participate in a clinical trial.
OSP: Then, please share some of the concerns the Renovia team might have discussed with ObvioHealth when planning and designing the study around the Ieva system.
MCN: Renovia was navigating unknown territory in uncertain times. The pandemic struck as the company was planning the trial. There had also never been a fully virtual study conducted in urogynecology.
Renovia expressed concern about the ability to ensure safety and monitor for adverse events. There was also a concern around the ability to maintain participant compliance and as well as hesitations about whether participants could properly be trained in a virtual environment. Finally, Renovia felt apprehensive about recruitment and retention considering the challenges with recruiting women, especially during a pandemic.
ObvioHealth helped Renovia optimize the protocol for a virtual study. We utilized our mobile app to assess changes in health status to help capture adverse events and monitor participant safety. Our virtual site team had personalized telehealth interactions with the participants as needed to monitor the compliance and ensure safety. This team was also able to answer patient questions and speak to any concerns they may have at any time during their journey with the trial using our mobile app.
OSP: Please share what you can about the digital recruitment strategy you and 1nHealth put together. How did you work to connect with women from different age groups?
Dan Brenner (DB): Our team focused in creating advertising content that was reflective of demographic nuances, which carried over to the advertising platforms and content we chose. For instance, our pre-launch research indicated that older urge-incontinence sufferers used and disliked disposable pads, while the younger age group typically went through an unwanted amount of underwear. Our content strategy reflected these insights, which led to a meaningful connection with key patient segments. 1nHealth’s content philosophy is that the research opportunity has to be presented central to the patient’s world—not to what the study needs.
OSP: Specifically, please tell us about how you managed to recruit in under 14 weeks. What were some of the tools and tricks you employed to accelerate recruitment and conserve costs?
DB: Online, direct-to-patient recruitment benefits from a rapid ability to scale, so getting the messaging to resonate with the audience on Day 1 allowed for this DCT study to fill quickly. Credit the Obviohealth COACH team (virtual site team) for being responsive to the massive influx of qualified participants and facilitating their enrollment into the study quickly.
OSP: Did you and your colleagues in the study learn any interesting lessons about DCT trial design and deployment from this experience?
MCN: In this study, 22% of participants were 65 years of age and older, with the oldest participant being 82 years of age. The more mature participants actually had higher compliance than the younger cohort which indicated the older participants not only completed their research related tasks as expected, but they were also able to easily navigate the mobile app/technology.
Some of the older participants appeared to be struggling to read the font on a few of our app screens. A couple days into the study, we quickly updated our mobile app to ensure legibility. Fortunately, our tech team was able to update the mobile app within a few days to accommodate the immediate need.