R33AG068486

Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) - SPRINT, and its accompanying cognitive-focused substudy SPRINT-MIND recently showed that blood pressure control (goal SBP<120 mm Hg) reduced incident mild cognitive impairment as well as a combined outcome of MCI and dementia. Divergence in opinion among experts and professional societies about BP goals still remain due to the concerns of potential harms.

There is a clear need to implement new practical approaches to control blood pressure in clinical practice and test their effectiveness. Pragmatic clinical trials embedded in health systems (EPCTS) offer a unique opportunity to study the effectiveness of implementation of evidence-based interventions in real-world clinical settings.

Our team is currently conducting ICD-PIECES (NCT02587936), the largest EPCT in patients with the coexistent chronic conditions of chronic kidney disease, hypertension, and diabetes as part of a demonstration project in the NIH Health Care Systems Research Collaboratory. We now propose the Preventing Cognitive Decline by Reducing BP Target Trial (PCOT), to examine the effects of lowering BP to less than 130/80 upon the incidence of cognitive decline.

Our main hypothesis is that patients who receive care with a collaboratory model that combines clinical decision support applied to home BPs and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care.

In this EPCT, we will compare the effects of intensive BP control between the intervention and usual care arm on the rate of cognitive decline measuring the change in TICS-M per year. We will recruit 4,000 patients over 70 years of age with BP >130/80 mmHg from 2 diverse health systems and randomize patients within each health system to usual care or to a combination of care with clinical decision support using home BPs and practice facilitators and PharmDs to lower home BP to <130/80 mmHg.

The primary outcome will be development cognitive decline as determined by a decrease in TICS-M scores from baseline. Additionally, we will determine the potential harms of intensive lowering BP home BP below 130/80 mmHg with usual care on hospitalizations, emergency department visits, cardiovascular events, deaths, syncope, falls, fractures, hypotension, electrolyte abnormalities, and acute kidney injury. We will also determine the impact of intensive BP management on quality of life with scores obtained using the PROMIS Scale V1.2 - Global Health Instrument annually.

This trial is pragmatic, with broad inclusion criteria and evidence-based interventions informed by patients and delivered in primary care settings by the clinical teams in health systems serving ethnically and socioeconomically diverse populations. Lessons from this trial should provide valuable insights to guide clinical practices in BP control and cognitive assessments in real-world settings, as well as design and implementation of future pragmatic trials.

The University Of Texas Southwestern Medical Center

NOT APPLICABLE

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Dallas, Texas 75390 United States

Single Zip Code

Implementation Research on Hypertension Control to Prevent Dementia and Cognitive Decline (R61/R33 Clinical Trial Optional) (RFA-AG-20-028)

Amendment Since initial award the total obligations have increased 313% from $1,241,873 to $5,122,897.