Clinical trial NCT01425515: Improving Care for Patients With High Blood Pressure
Official title: Heart Healthy Lenoir: Improving Care for Patients With High Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Disease Risk
Keywords: hypertension
genomics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-08-30
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: systolic blood pressure
timeFrame: 2 years
Secondary outcomes:
measure: Blood lipids
timeFrame: 2 years
measure: General Cardiovascular Disease Risk
timeFrame: 2 years
measure: Genomic predictors of blood pressure change
timeFrame: 6-, 12-, 18, and 24-month follow-up
Other outcomes:
Locations:
city: Kinston
country: United States
facility: Kinston Enterprise Center - Study Office
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jacqueline Halladay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cummings DM, Adams A, Halladay J, Hinderliter A, Donahue KE, Cene CW, Li Q, Miller C, Garcia B, Tillman J, Little E, DeWalt D. Race-Specific Patterns of Treatment Intensification Among Hypertensive Patients Using Home Blood Pressure Monitoring: Analysis Using Defined Daily Doses in the Heart Healthy Lenoir Study. Ann Pharmacother. 2019 Apr;53(4):333-340. doi: 10.1177/1060028018806001. Epub 2018 Oct 3.
citation: Chatterjee A, Daftary G, Gatison L, Gillman MW. Lessons Learned From a Partnership to Evaluate a School Food Program. Prog Community Health Partnersh. 2016;10(4):577-584. doi: 10.1353/cpr.2016.0066.
citation: Cummings DM, Wu JR, Cene C, Halladay J, Donahue KE, Hinderliter A, Miller C, Garcia B, Penn D, Tillman J, DeWalt D. Perceived Social Standing, Medication Nonadherence, and Systolic Blood Pressure in the Rural South. J Rural Health. 2016 Spring;32(2):156-63. doi: 10.1111/jrh.12138. Epub 2015 Sep 3.
citation: Halladay JR, Donahue KE, Hinderliter AL, Cummings DM, Cene CW, Miller CL, Garcia BA, Tillman J, DeWalt D; Heart Healthy Lenoir Research Team. The Heart Healthy Lenoir project--an intervention to reduce disparities in hypertension control: study protocol. BMC Health Serv Res. 2013 Oct 25;13:441. doi: 10.1186/1472-6963-13-441.