Cardiovascular Disease Risk, Hypertension
Conditions
Keywords
hypertension, genomics
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.
Interventions
BEHAVIORALComplex 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| systolic blood pressure | 2 years | We will measures blood pressure at enrollment and then every 6 months for 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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. |
Countries
United States
Outcome results
None listed