How the DeTAP Study Overcame Participation Barriers in a Fully Decentralized Trial for Atrial Fibrillation Patients

Challenge
Recruitment is often the Achilles heel of clinical trials, with studies showing that up to 86% struggle to meet their enrollment targets on schedule. This was no different for the DeTAP study, as by design, it started out as a traditional study with onsite recruitment and onboarding. These Initial recruitment efforts using traditional methods yielded only 6 participants, far below the enrollment target. 

Additionally, the study’s complex operations presented another major challenge. The study participants, who were older adults, often less familiar with digital tools, were required to use a study app and medical devices to measure blood pressure and collect electrocardiogram (ECG) readings at home. Onboarding older participants onto this app and ensuring they could correctly use both the app and the associated medical devices was a critical concern. The DeTAP team needed a platform to facilitate recruitment, streamline operations, and prioritize patient support throughout the study, ensuring they felt confident and connected, even from home.‍

The Solution
The study team turned to the Studypages platform, offering fully integrated trial technology designed to provide participants with a high-touch experience while simplifying clinical trial operations. This wasn’t just about adding another technology for technology’s sake—it was about finding a solution that allowed the team to be participant-centered, making the entire process easier and more efficient for everyone involved.

To meet the aggressive enrollment goal, recruitment efforts shifted to a completely digital recruitment strategy powered by Studypages. Through targeted social media campaigns, the team was able to connect with a much broader group of potential participants. This digital-first approach expanded their reach and made the enrollment process incredibly user-friendly. Participants could sign up, complete pre-qualification surveys, and sign consent forms—all from the comfort of their homes.

A key element in this strategy was Studypages’ participant-facing branded microsite. This was the central hub where potential participants could find all the information they needed about the trial. The microsite's clear, accessible design helped build trust with participants, making it easy for them to take the first steps toward enrollment.

But Studypages didn’t stop at recruitment and enrollment. The platform’s collaborative workspace played a pivotal role in team operations coordination, allowing the study team to track and manage trial progress in real-time. This level of coordination was essential in a decentralized trial, where the team had to manage participants across various locations without the need for in-person meetings. For example, after a patient filled out the survey on the Studypages platform and was deemed eligible, they would receive an automated email and text link to upload a photo of their OAC prescription bottle. This photo was then evaluated by the study coordinator at the Stanford Center for Clinical Research (SCCR) to confirm OAC usage. Once confirmed, the participant was sent an SMS text message with a link to the electronic informed consent form for DeTAP.

Onboarding elderly participants onto the study app was another critical task, and Studypages’ user-friendly interface made this process much smoother. The platform’s remote monitoring tools allowed participants to easily input their health information and transmit it securely to the study team. This ensured the data's accuracy and reliability while empowering participants to actively manage their health from home. 

Moreover, Studypages’ intuitive communication tools enabled the study team to efficiently and securely connect with participants, providing regular updates, reminders, and virtual check-ins. This continuous interaction helped participants feel supported and informed, significantly reducing the risk of dropouts.   ‍