Preventing Cognitive Decline by Reducing BP Target Trial

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05106036
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 11, 2022
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
4,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Cognitive Decline [ Time Frame: 4 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Miguel Vazquez, MD
[email protected]
214-648-3442
Wanpen Vongpatanasin, MD
[email protected]
214-648-9078

Find similar trials in Dallas, TX

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
UT Southwestern Medical Center· Dallas, TX

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