Using Digital Health Tools and AI to Improve Outcomes for Patients with Irregular Heartbeat

It’s difficult for people to change their everyday behaviors, even when they know the changes are better for their health.

As a cardiologist specializing in heart rhythm disorders, Dr. Nino Isakadze always emphasizes the importance of lifestyle modifications to her patients with atrial fibrillation (Afib), an irregular heartbeat that is more common in people 60 and older. According to clinical guidelines, modifying risk factors such as weight, physical activity, and tobacco and alcohol use are critical for managing Afib and preventing adverse outcomes such as stroke, heart attack, and death.

“Lifestyle modification is challenging for patients and especially elderly populations, and it’s not something that everyone is ready to jump right into,” Isakadze said.

Working with patients, clinicians, and digital technology experts, Isakadze’s team at Johns Hopkins University developed a Virtual Atrial Fibrillation Management Program that uses digital health technologies (DHTs) including a smartwatch and app to help patients achieve these lifestyle changes.

With funding from the PhRMA Foundation, Isakadze is conducting a randomized controlled trial examining whether patients who use the virtual program experience improved outcomes. The 12-week program integrates:

• an Apple watch to track heart health data
• a mobile app to educate and empower patients in tracking their health and setting health goals
• a clinician dashboard with patient data from the mobile app and smartwatch
• individualized weekly health coaching to promote adherence to the program

After the intense 12-week program, participants receive monthly coaching calls for nine months.

“The digital health technologies that we use in everyday life, such as smartphones and smartwatches, can be great tools, providing daily reminders to help us with behavior change and risk factor modification,” Isakadze said.

A previous pilot study of 65 patients confirmed the feasibility of implementing the program. However, that study struggled to enroll diverse patients, including women and individuals from underrepresented racial and ethnic minority groups. For the new study, Isakadze aims to enroll 350 patients and is taking steps to improve representation from these groups.

The study team created a Digital Health Community Task Force made up of local leaders from underrepresented communities. “They have expertise in what their communities need,” she said. “They help make sure that we are doing things that are going to resonate with these diverse communities.”

For example, the task force provided feedback on the design and language for flyers created to educate patients about atrial fibrillation and encourage them to seek care in the Afib clinic. The task force members also help distribute these flyers at community events. Once patients establish care in the Afib clinic, in addition to standard of care, they are eligible to participate in clinical trials, including the virtual risk factor modification trial.

The study team also established an advisory board of Afib patients and sought feedback from those who participated in the pilot study. One patient even created a PowerPoint presentation with their feedback about the initial study and ideas for improvements. “They loved the intervention so much that they want everyone with Afib to have a chance to get their hands on it,” Isakadze said.

The Patient Advisory Board engages in tasks such as reviewing and providing feedback on the coaching document that guides the nurses working with study patients. For instance, the Patient Advisory Board gave advice on how often nurses should call patients, when they should call, and how to improve the reminder notifications that patients receive.

While these guidelines are helpful, Isakadze noted that the program really requires an individualized approach for each patient based on their needs. “It’s not going to be a prescription that is one-size-fits-all,” she said.

As the prevalence of Afib increases, Isakadze hopes the PhF-funded study will confirm the program’s effectiveness in improving patient-reported outcomes such as quality of life and Afib symptom severity as well as clinically meaningful digital outcomes such as Afib recurrence and change in health metrics including weight and blood pressure.

The study could serve as an example for those seeking to create similar programs for other diseases. “We are noting all the ups and downs so that this can be a learning process and generalizable beyond our study,” Isakadze said.

She also aims to advance understanding of DHT use patterns and behaviors predicting successful behavior change using artificial intelligence. She plans to develop best practices and standards for inclusivity in clinical trials using DHTs to aid the Food and Drug Administration (FDA) with regulatory decision-making.

“If we show superior outcomes, that could lead to multi-site studies and then potentially guideline changes so that this can be implemented for patient care and reimbursed,” she said. “I hope that we can offer it to every patient. Those are my hopes and dreams from this study.”

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