Improving Care for Patients With High Blood Pressure

NCT ID: NCT01425515

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Hypertension Cardiovascular Disease Risk

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Jacquie Halladay, MD, MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacqueline Halladay, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Kinston Enterprise Center - Study Office

Kinston, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18212285 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30282468 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28569683 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26334761 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24156629 (View on PubMed)

Related Links

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http://hpdp.unc.edu/research/projects/heart-healthy-lenoir/

Summary information about the Heart Healthy Lenoir Project

Other Identifiers

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P50HL105184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-0395

Identifier Type: -

Identifier Source: org_study_id