November 20, 2023

Managing blood pressure among stroke survivors is essential in reducing the risk of repeated stroke and cardiovascular events, but questions remain about the best way to provide care and support patients.

Now, a major clinical trial — launched in the southeastern United States and co-run by researchers at the UNC Gillings School of Global Public Health — seeks to answer those questions in part by expanding its footprint with the addition of two sites in Illinois: Advocate Christ Medical Center and Advocate Lutheran General Hospital.

In 2021, researchers at North Carolina’s Wake Forest University School of Medicine, the academic core of Advocate Health, received a $29.9 million, six-and-a-half-year award from the Patient-Centered Outcomes Research Institute (PCORI) and launched a multi-center, patient-randomized control trial to test two interventions to lower blood pressure in the first six months following a stroke.

The trial contrasts one intervention that relies on telehealth with another that uses in-person clinic management.

Dr. Wayne Rosamond

Dr. Wayne Rosamond

Researchers at the University of North Carolina at Chapel Hill’s Gillings School lead the data coordinating center for the trial. The UNC team is led by co-principal investigator Wayne Rosamond, PhD, professor of epidemiology at Gillings.

“Now that we have completed the feasibility phase of the trial, we are excited to continue our collaboration with Wake Forest to scale up the research design and data systems from what was used in the three clinical centers involved in the feasibility phase to, now, 11 main trial clinical centers,” Rosamond said. “Our team at UNC will continue to provide scientific leadership in decision making regarding the analytical, statistical and data management aspects of the trial.”

This is one of the first Wake Forest University School of Medicine studies that will enroll participants at Advocate Health locations since Advocate Aurora Health and Atrium Health announced their combination in late 2022.

“We’re thrilled to bring this study to Illinois,” said Cheryl D. Bushnell, MD, professor and vice chair of neurology at Wake Forest University School of Medicine and principal investigator of the trial. “Our goal with this study perfectly aligns with the overall mission of redefining how best to meet patients’ needs.”

Bushnell said there’s also an emphasis on enrolling underrepresented populations who are at higher risk for recurrent stroke.

“As the academic core of Advocate Health, one of our top priorities has been to begin expanding clinical research to cover a much larger footprint of the United States,” said Ebony Boulware, MD, dean of Wake Forest University School of Medicine and chief science officer at Advocate Health. “Giving more people, across a much wider geographic area, the opportunity to participate in clinical trials helps us build even stronger research studies, improve health equity and accelerate the speed at which we can translate scientific findings into improved clinical care for our patients and our communities.”

Researchers will enroll 1,550 participants, who are being randomized to either an Intensive Tailored Telehealth Management (ITTM) or Intensive Clinic Management (ICM) intervention.

The ITTM intervention involves monitoring blood pressure at home through use of a cell phone enabled blood pressure cuff, individualized health care coaching and remote clinical care, while the ICM intervention occurs in-person, with frequent blood pressure monitoring and clinical care.

Participants for the new study also are being recruited from Atrium Health Carolinas Medical Center and Atrium Health Wake Forest Baptist Medical Center — both in North Carolina.

Additional participating clinic sites include Duke University Medical Center, Medical University of South Carolina, Health Sciences South Carolina, Vanderbilt University Medical Center, Mayo Clinic Florida, University of Alabama Hospital and Erlanger Health.

“We are optimistic that telehealth is a promising strategy in lowering blood pressure,” Bushnell said. “Given the prevalence of stroke, it’s imperative that we provide interventions that are effective and accessible.”

PCORI is an independent, nonprofit research funding organization authorized by the U.S. Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with evidence-based information to make better-informed health care decisions.

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