Managing blood pressure among stroke survivors is essential in reducing the risk of recurrent stroke and cardiovascular events, but questions remain about the best way to provide care and support patients who are at risk.
In 2021, researchers at 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 - one utilizes telehealth, and the other is in-person clinic management.
Now, the clinical trial is expanding its footprint with the addition of two Advocate Health sites - Advocate Christ Medical Center, in Oak Lawn, Illinois, and Advocate Lutheran General Hospital, in Park Ridge, Illinois.
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, M.D., 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 under-represented 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, M.D., 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 cellular-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.
The study is an extension of a previous research collaboration between Wake Forest University School of Medicine and the UNC Gillings School of Global Public Health on post-acute stroke care - COMprehensive Post-Acute Stroke Services Study (COMPASS).
The Gillings School team is the data coordinating center, which is led by co-principal investigator Wayne Rosamond, Ph.D., professor of epidemiology.
Participants are also being recruited from Atrium Health Carolinas Medical Center, in Charlotte and Atrium Health Wake Forest Baptist Medical Center, in Winston-Salem.
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 Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with evidence-based information needed to make better-informed health care decisions.