Tailored to You (TTY) Pilot Study

Study Overview
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Brief Summary
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The purpose of this research study is to use a test called impedance cardiography (ICG) to provide more information about how to improve the control of blood pressure. Participants will be given this test so investigators can get more information about what is going on inside the heart and blood vessels that is contributing to high blood pressure. ICG is a lot like an EKG (electrocardiogram) in that it uses electrodes and a computer to make a report. Participants will lie down on the exam table and two electrodes go on the right ankle and two electrodes go on the left wrist. The process takes about 5 minutes and is painless and not invasive.

Official Title
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The Duke Primary Care Tailored to You (TTY) Blood Pressure Control Pilot Study

Conditions
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Hypertension

Intervention / Treatment
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* Device: Hypertension medication algorithm
* Device: Impedance Cardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of hypertension Most recent office systolic BP average measured using automated office BP (AOBP) is ≥140 mmHg systolic or ≥90 mmHg diastolic Currently prescribed at least one BP-lowering medication Under the care of a primary care clinician Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertension patients<br>Patients with documented diagnosis of hypertension and their most recent office systolic BP average measured using automated office BP is ≥140 mmHg systolic or ≥90 mmHg diastolic and they are currently prescribed at least one BP-lowering medication will be recruited. | Device: Hypertension medication algorithm<br>* The algorithm is configured to align medication choices based on the hemodynamic findings from the ICG readings. This decision support tool was created so as to organize these medications based on their mechanism of action and is consistent with the evidence-based treatment of hypertension.<br>Device: Impedance Cardiography<br>* The ICG system provides a printed report that indicates whether a person's hemodynamic state is predominantly one that is vasoconstricted, hyperdynamic, or mixed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Enrolled as Measured by Enrollment Logs |  | 1.5 months | 
| Number of Participants That Completed Study as Measured by Enrollment Logs |  | 1.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure as Measured by Medical Record |  | Baseline, 4 months | 
| Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review |  | Up to 4 months |