Recruiting

Cognitive Decline

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05106036

Conditions

Cognitive Decline

Blood Pressure

Hypertension

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Clinical Support Decision Tool

Study Details

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

Study ID

NCT05106036

Start date

Jul 11, 2022

Status verified date

Nov, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

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. .

no intervention: Usual Care Arm

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

Interventions

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 outcome measure

  • Cognitive Decline [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Venkatraghavan Sundaram, Ph.D.

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

Miguel Vazquez, MD

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

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Miguel Vazquez, MD

214-648-3442Miguel.Vazquez@UTSouthwestern.edu

Wanpen Vongpatanasin, MD

214-648-9078Wanpen.Vongpatanasin@UTSouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-12-03.