Tailored to You (TTY) Pilot Study

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Hypertension medication algorithm; Device: Impedance Cardiography

• Registration Number: NCT05141175
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Study Start: 2022-01-10
• Primary Completion: 2022-03-01
• Study Completion: 2022-06-28
• Results First Submitted: 2023-02-23
• Status Verified: 2023-03
• Results First Submitted QC: 2023-04-27
• Last Update Submitted: 2023-04-27
• Results First Posted: 2023-05-01
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypertension patients	Hypertension medication algorithm	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.
Hypertension patients	Impedance Cardiography	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Completed Study as Measured by Enrollment Logs	1.5 months
Number of Participants Enrolled as Measured by Enrollment Logs	1.5 months

Secondary Outcome Measures

Name	Time	Method
Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review	Up to 4 months
Change in Blood Pressure as Measured by Medical Record	Baseline, 4 months

Trial Locations

Locations (1)

Duke Primary Care; 🇺🇸 Durham, North Carolina, United States