Improving Care for Patients With High Blood Pressure

Hypertension Clinical Trial

Official title:

Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425515
• Other study ID #: 10-0395
• Secondary ID: P50HL105184
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: November 17, 2014
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease Risk
• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Complex quality improvement intervention
We are implementing a complex quality improvement intervention that includes changes in practice processes to enhance hypertension care, provision of home blood pressure monitors to patients, and telephone coaching around hypertension self-management.

Locations

Country	Name	City	State
United States	Kinston Enterprise Center - Study Office	Kinston	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure	We will measures blood pressure at enrollment and then every 6 months for 24 months.	2 years	No
Secondary	Blood lipids	We will measure blood lipids including total cholesterol and HDL over the course of the study to calculate overall cardiovascular risk.	2 years	No
Secondary	General Cardiovascular Disease Risk	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)	2 years	No
Secondary	Genomic predictors of blood pressure change	A systems approach to developing genomic models integrating clinical and genomic data.	6-, 12-, 18, and 24-month follow-up	No

External Links

•   Summary information about the Heart Healthy Lenoir Project