RecruitingNot ApplicableNCT05106036

Preventing Cognitive Decline by Reducing BP Target Trial

Sponsor

University of Texas Southwestern Medical Center

Enrollment

4,000 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

Hypertension Blood Pressure Cognitive Decline

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.

Eligibility

Min Age: 70 Years

Inclusion Criteria6

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

Exclusion Criteria9

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

Interventions

OTHERClinical 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.