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Clinical Support Tool for Preventing Cognitive Decline (PCOT Trial)

N/A

Recruiting

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Must not have

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

Chronic kidney disease stage 5 or ESKD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a combination of clinical decision support and team-based care can help reduce blood pressure and prevent cognitive decline in elderly patients.

Who is the study for?

This trial is for people aged 70 or older with high blood pressure, defined as two readings of SBP >= 130 or DBP >=80 in the last 24 months. Participants must be able to communicate in English or Spanish, have visited a primary care provider within the last two years, and own a smartphone or tablet.

What is being tested?

The PCOT study tests if patients receiving team-based care and using a clinical decision support tool have better blood pressure control and lower rates of mild cognitive impairment compared to those getting usual medical care.

What are the potential side effects?

Since this trial involves non-drug interventions like clinical support tools and team-based care approaches rather than medications, traditional side effects are not applicable. However, there may be indirect effects related to changes in healthcare management.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have recent severe heart issues or organ transplants.

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I have advanced kidney disease or am on dialysis.

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I am younger than 70 years old.

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I have dementia, Alzheimer's, or a major neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognitive Decline

Secondary study objectives

Mild Cognitive Decline or Dementia

Other study objectives

BP Above 130/80

Change in quality of life assessment

Combination Pill Use

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

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. .

Group II: Usual Care ArmActive Control1 Intervention

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

0 / 4Eligibility criteria met