Back to resultsTailored to You (TTY) Pilot Study
Primary Purpose
Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypertension medication algorithm
Impedance Cardiography
Sponsored by
About this trial
This is an interventional other trial for Hypertension
Eligibility Criteria
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:
-
Sites / Locations
- Duke Primary Care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypertension patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants Enrolled as Measured by Enrollment Logs
Number of Participants That Completed Study as Measured by Enrollment Logs
Secondary Outcome Measures
Change in Blood Pressure as Measured by Medical Record
Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05141175
Brief Title
Tailored to You (TTY) Pilot Study
Official Title
The Duke Primary Care Tailored to You (TTY) Blood Pressure Control Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypertension patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hypertension medication algorithm
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Impedance Cardiography
Intervention Description
The ICG system provides a printed report that indicates whether a person's hemodynamic state is predominantly one that is vasoconstricted, hyperdynamic, or mixed
Primary Outcome Measure Information:
Title
Number of Participants Enrolled as Measured by Enrollment Logs
Time Frame
1.5 months
Title
Number of Participants That Completed Study as Measured by Enrollment Logs
Time Frame
1.5 months
Secondary Outcome Measure Information:
Title
Change in Blood Pressure as Measured by Medical Record
Time Frame
Baseline, 4 months
Title
Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Viera, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Primary Care
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Tailored to You (TTY) Pilot Study
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