Improving Care for Patients With High Blood Pressure

NCT01425515 | Completed DMC

• 2 other identifiers: 10-0395P50HL105184
• Study Type: interventional
• Target: 535
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Disease Risk

Keywords

hypertension; genomics

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure

  We will measures blood pressure at enrollment and then every 6 months for 24 months.

  2 years

Secondary Outcomes (3)

• Blood lipids

  2 years

• General Cardiovascular Disease Risk

  2 years

• Genomic predictors of blood pressure change

  6-, 12-, 18, and 24-month follow-up

Interventions

Complex quality improvement intervention BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Kinston Enterprise Center - Study Office

Kinston, North Carolina, 28501, United States

Location

Related Publications (5)

• 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.

  PMID: 18212285 BACKGROUND

• 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.

  PMID: 30282468 DERIVED

• 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.

  PMID: 28569683 DERIVED

• 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.

  PMID: 26334761 DERIVED

• 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.

  PMID: 24156629 DERIVED

Related Links

• Summary information about the Heart Healthy Lenoir Project

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jacqueline Halladay, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

US (1)