Preventing Cognitive Decline by Reducing BP Target Trial

NCT05106036 | Recruiting DMC

• 2 other identifiers: STU-2021-0735R33AG068486
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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

Cognitive Decline; Blood Pressure; Hypertension

Outcome Measures

Primary Outcomes (1)

• Cognitive Decline

  Rate of change in Modified Telephone Interview for Cognitive Status (TICS-m) test between study arms. The test has scores ranging from 0 to 42 with higher values indicating better cognitive status.

  4 years

Secondary Outcomes (1)

• Mild Cognitive Decline or Dementia

  4 years

Other Outcomes (8)

• Number of Pharmacy Refills

  4 years

• Change in quality of life assessment

  4 years

• Number of encounters within the participant's health system

  4 years

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Home BP data will be averaged each month via OmronConnect app on the patients' smartphone, which is programmed to send home BP readings to MyChart via Apple or Google Health.Participants whose home blood pressure reading average is systolic ≥ 130 and diastolic ≥ 80 will trigger the CDS (Clinical Decision Support) tool to assist their physicians with their blood pressure management. Study Team will not be involved in treatment decision making, it will be determined by subject's treating physician. .

Other: Clinical Support Decision Tool

Usual Care Arm

NO INTERVENTION

Physicians will continue to make decisions about the participant's blood hypertension management as usual without the CDS tool.

Interventions

Clinical Support Decision Tool OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Ability to understand and willingness to provide informed consent
• Owns a smartphone

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Aging (NIA): collaborator
• Duke University: collaborator
• Parkland Health and Hospital System: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Hypertension

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Venkatraghavan Sundaram, Ph.D.

CONTACT

214-590-3848; venkatraghavan.sundaram@phhs.org

Miguel Vazquez, MD

CONTACT

214-648-3442; miguel.vazquez@utsoutwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clinical Director, Division of Nephrology

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 3, 2021
• Study Start: July 11, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)