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Clinical Trials/NCT01425515
NCT01425515CompletedNot Applicable

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

University of North Carolina, Chapel Hill2 sites in 1 country535 target enrollmentStarted: September 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
535
Locations
2
Primary Endpoint
systolic blood pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

systolic blood pressure

Time Frame: 2 years

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

Secondary Outcomes

  • General Cardiovascular Disease Risk(2 years)
  • Blood lipids(2 years)
  • Genomic predictors of blood pressure change(6-, 12-, 18, and 24-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacquie Halladay, MD, MPH

Associate Professor

University of North Carolina, Chapel Hill

Study Sites (2)

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