Improving Care for Patients With High Blood Pressure

Not Applicable

Completed

• Conditions: Hypertension; Cardiovascular Disease Risk

• Registration Number: NCT01425515
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The investigators are conducting a single group intervention study to improve blood pressure control and reduce racial and literacy related disparities among people with hypertension. The intervention includes providing patients with home blood pressure monitors, administering phone-coaching to participants, and improving hypertension care at the participating practices from which patients are enrolled. The investigators will follow the patients for 2 years to determine if blood pressure control improves. In addition, the project will explore genetic factors associated with cardiovascular disease risk and treatment success.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Study Start: 2011-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

• Men and women who meet the following inclusion criteria will be eligible for study participation:
• 18 years or older,
• Able and willing to give informed consent,
• A current patient of 1 of the 5 participating practices,
• Have a current diagnosis of hypertension by their primary care physician or have 3 documented blood pressures above 150/90,
• Their most recent systolic blood pressure was greater than or equal to 150 at their most recent clinic visit,
• Receive physician approval to participate in the study.
• Anyone enrolled in the High Blood Pressure study is eligible to participate in the genomics component of the project.

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Exclusion Criteria

• non-English speaking,
• current treatment of psychosis,
• diagnosed with advanced dementia as determined by the clinician,
• current substance abuse,
• lack of phone access,
• history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for > 5 years,
• estimated creatinine clearance less than 30 ml/min (because hypertension management becomes more complicated at this point),
• are pregnant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
systolic blood pressure	2 years	We will measures blood pressure at enrollment and then every 6 months for 24 months.

Secondary Outcome Measures

Name	Time	Method
General Cardiovascular Disease Risk	2 years	We will measure variables (blood pressure, cholesterol, aspirin use, smoking status, and diabetes status) to calculate general cardiovascular disease risk which includes (coronary death, myocardial infarction, coronary insufficiency, angina, ischemic stroke, hemorrhagic stroke, transient ischemic attack, peripheral artery disease, heart failure). (D'Agostino, 2008)
Blood lipids	2 years	We will measure blood lipids including total cholesterol and HDL over the course of the study to calculate overall cardiovascular risk.
Genomic predictors of blood pressure change	6-, 12-, 18, and 24-month follow-up	A systems approach to developing genomic models integrating clinical and genomic data.

Trial Locations

Locations (1)

Kinston Enterprise Center - Study Office; 🇺🇸 Kinston, North Carolina, United States