Huma Published Study Results in Fully DCT in Atrial Fibrillation Patients

Huma Therapeutics, in partnership with Bayer and Stanford University, published study results from its fully decentralized trial (DCT) in atrial fibrillation patients (DeTAP) in NPJ’s Digital Medicine. Rajesh Dash, MD, PhD, associate professor of medicine at the Stanford School of Medicine was the principal investigator of the trial. Based on the results from one of the first peer-reviewed assessments, outcomes of rapid recruitment, high engagement, and increased medication adherence were found among atrial fibrillation patients.

Historically, up to 86% of clinical trials do not achieve enrollment targets in their desired time making recruitment for traditional clinical trials an issue. The study showed that fully decentralized trials such as the DeTAP where there were 94 patients recruited in the span of 12 days using social media along with a waitlist of 300 or more, shows potential to be beneficial for the recruitment process. The participants recruited in the study were aged >55 years old on an oral anticoagulation (OAC) medication. Participants in the DeTAP study used FDA-approved devices that connected to Huma’s app, allowing researchers to take measurements and assess patient results remotely instead of the patients having to travel to the clinic to collect them. Patients in the DeTAP also increased their medication adherence when normally up to 30% of a-fib patients do not adhere to their medication.

The study’s aim was to validate the feasibility, acceptability, and best practices of coordinating/integrating several individual digital health technologies to achieve execution of high compliance, cost-efficient, and scientifically sound clinical trials. The type of study was an interventional, clinical trial, which started on August 10, 2020 and ended August 2021. The intervention/treatment used the DeTAP app which collected the data, had a televisit function, provided information and reminders. The trial also used a Bluetooth-connected electrocardiogram (EKG) and blood pressure device for the participants to provide researchers the data virtually.

The official title of the study was named “Decentralized Trial in Atrial Fibrillation Patients (DeTAP): Validation of a Combined Digital Health Technology Approach to Fully Decentralize an Intervention to Administer, Promote, and Track Oral Anticoagulant Therapy [https://clinicaltrials.gov/ct2/show/NCT04471623].” The primary outcome measures of the study were engagement with the study protocol, e.g. percentage of OAC adherence, and effectiveness of notifications, e.g. time from app-based survey notification completion, over the time frame of the six months. As for the criteria for the eligibly, participants had to have a diagnosis of atrial fibrillation documented within the past year and taking the OAC medication for stoke. They also had to have used a smart phone daily and was willing to use apps and home devices for the study. Lastly, the participants had to be agreeable to use a televisit method to conduct all the study visits from a trial team.

Read more about the news release here.