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Preventing Cognitive Decline by Reducing BP Target Trial

The PCOT study is a multi-site randomized trial of patients 70 years or older with high BP. The main goal of the study Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) is to conduct a large pragmatic clinical trial (PCT) to test the hypothesis that patients who receive care with a combination of clinical decision support (CDS) 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…

ClinicalTrials.gov IDNCT05106036

PhaseNA

Enrollment4000

SponsorUniversity of Texas Southwestern Medical Center

Age70 Years

SexALL

I'm interested View official listing

Conditions studied

Cognitive Decline, Blood Pressure, Hypertension

About this study

Interventions

Other: Clinical Support Decision Tool — Participants whose home blood pressure reading average is systolic ≥ 130 and diastolic ≥ 80 will trigger the Clinical Decision Support (CDS) tool to assist their physicians with their blood pressure management. Home BP data will be averaged each month via Omron Connect app on the patients' smartphone, which is programmed to send home BP readings to MyChart via Apple or Google Health. We have designed CDS to present treatment choices of antihypertensive medication regimen based on medications patients are currently taking. For example, patients who are currently taking an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), our CDS algorithm will recommend addition of a calcium channel blocker as the first tier of recommendation and thiazide diuretics as second tier of recommendation. Laboratory data and home BP in the past month will be presented in a clear and simple manner for the clinicians to activate and use to optimize BP control.

Primary outcomes

Cognitive Decline (4 years)

Eligibility information

Inclusion Criteria: * High BP defined as at least 1 BP readings of SBP \>= 130 or DBP \>=80 during the 24 months prior to enrollment * Clinic visit with primary care provider within the last 24 months * Ability to write and speak English or Spanish * 70 years of age or older * Ability to understand and willingness to provide informed consent * Owns a smartphone Exclusion Criteria: * Blood pressure consistently \<130/80 mmHg * Presence of dementia, Alzheimer's disease, or significant neurological disease * Major and unstable heart disease (e.g., acute heart failure (systolic or diastolic), acute on chronic heart failure (systolic or diastolic), acute coronary syndrome or cardiac arrest, liver or renal transplantation * Under 70 years of age * Inability to write or speak English or Spanish * Chronic kidney disease stage 5 or ESKD * Chemotherapy * Any conditions judged by the medical providers to contraindicate participation due to risk to patient safety or lack of adherence * Expected life expectancy under a year

Study locations

UT Southwestern Medical Center, Dallas, Texas 75390 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.