NCT05106036 · University of Texas Southwestern Medical Center
Preventing Cognitive Decline by Reducing BP Target Trial
(PCOT)
What this study is about
The PCOT study is a multi-site randomly assigned 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.
View original scientific description
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.
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 outcome measures
Cognitive Decline
Time frame: 4 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Dallas, Texas
Collaborators
National Institute on Aging (NIA), Duke University, Parkland Health and Hospital System
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 3, 2025 · Source of record for eligibility and locations