Chip Faircloth, EVP
Wake Forest School of Medicine Researchers Receive $29.9 Million Award to Study Effectiveness of Blood Pressure Interventions
INTERVENT to provide telehealth coaching to all participants from the study's nine major Southeastern medical centers
Savannah, Georgia - August 11, 2021 - People living in the South, known as the Stroke Belt, are not only at a greater risk of having strokes, but the region is also associated with higher stroke mortality. The link between high blood pressure and stroke is well-known, and lowering blood pressure reduces stroke risk. But how can blood pressure be most effectively managed among stroke survivors, and is the use of telehealth the most effective strategy?
Researchers at Wake Forest School of Medicine hope to answer those questions with a $29.9 million, six-and-a-half-year award from Patient-Centered Outcomes Research Institute (PCORI) - an independent, nonprofit, nongovernmental research funding organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.
PCORI's Board has approved this award pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
The multi-center, patient-randomized control trial is being led by Cheryl D. Bushnell, M.D., stroke division chief and professor of neurology for Wake Forest School of Medicine. This award will fund the first study of its kind 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.
"Using telehealth was necessary during the COVID-19 pandemic," Bushnell said. "And we believe telehealth could be an effective strategy for managing patient risk factors, specifically lowering blood pressure to targets that ultimately reduce the risk of recurrent stroke and cardiovascular events."
Study participants will be 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 Bluetooth-enabled blood pressure cuff, individualized health care coaching and remote clinical care, while the ICM intervention occurs primarily in-person, with frequent blood pressure monitoring and clinical care. INTERVENT International ("INTERVENT") has been selected to provide the tailored telehealth coaching on risk factor and lifestyle management, as well as remote patient monitoring, to patients in the ITTM arm, and guideline-based risk factor and lifestyle coaching to patients in the ICM arm.
"Stroke is one of the leading causes of death and disability, and high blood pressure is a modifiable risk factor," Bushnell said. "No matter which intervention proves most effective, we believe this trial will have a major impact on blood pressure management in stroke patients, especially in under-represented minorities, the elderly and those with residual disabilities."
The study is an extension of a previous research collaboration between Wake Forest and the UNC Gillings School of Global Public Health on post-acute stroke care- COMprehensive Post-Acute Stroke Services Study (COMPASS).
As part of the new trial, the Gillings School team will receive $8.2 million of the award to lead the data coordinating center with co-investigator Wayne Rosamond, Ph.D., professor of epidemiology.
"This study leverages advances in technology to enhance remote patient-clinician interaction around the common problem of blood pressure management that could have an impact on clinical practice of stroke care, as well as other conditions," Rosamond said.
Participating clinic sites, all located in the southeast, include Wake Forest Baptist Medical Center, UNC Medical Center, 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.
Neil Gordon, M.D., Ph.D., M.P.H., INTERVENT's CEO and medical director, said, "Study patients will receive ongoing, high-quality chronic care management services, including individualized assistance in making and adhering to meaningful lifestyle changes." He also stated that "This important new study is the third landmark multi-center stroke-related clinical trial to use INTERVENT's evidence-based telehealth coaching program. The first study (SAMMPRIS), funded by the NIH and published in the New England Journal of Medicine and Lancet, helped establish the value of telehealth coaching when used in collaboration with stroke neurologists to reduce cerebrovascular events. The second NIH-funded study (CREST-2), involving over 135 medical centers, is currently in progress. We could not be more excited about working with our colleagues from the prestigious institutions/comprehensive stroke programs participating in this practical new study. In the process, care will be evaluated and transformed to improve the recovery, health and wellbeing of stroke patients."
INTERVENT International is a physician-led, global, technology-driven behavior change and population health management company that provides its services primarily via digital and telehealth approaches. INTERVENT develops, licenses and provides evidence-based, technology-enabled, data-driven programs for the prevention and management of multiple chronic diseases (including stroke) and cost-drivers. INTERVENT's programs have been proven effective in more than 115 published scientific abstracts and manuscripts, including randomized and independently-conducted clinical trials published in prestigious peer-reviewed scientific journals. More than two million individuals have participated in INTERVENT's programs, including patients from over 130 medical centers in the U.S. and Canada as part of two recent multi-center clinical trials (SAMMPRIS and CREST-2) funded by the National Institutes of Health. INTERVENT's digital/telehealth coaching program is currently being used by all participants in the Canadian Diabetes Prevention Program. For more information, visit www.interventhealth.com or email email@example.com.