Preventing Cognitive Decline by Reducing BP Target Trial

NCT05106036 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2025-12-03

No results posted yet for this study

Summary

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 receiving usual medical care. Patients will be recruited from UT Southwestern Medical Center and Parkland Health \& Hospital System.

Conditions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Duke University

    collaborator OTHER
  • Parkland Health and Hospital System

    collaborator OTHER
  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05106036 on ClinicalTrials.gov