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Completed

NCT Number: NCT01425515

Improving Care for Patients With High Blood Pressure

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.

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Key information

Conditions

Hypertension Cardiovascular Disease Risk Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kinston Enterprise Center - Study Office

Kinston, North Carolina, 28501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. systolic blood pressure

    Time frame: 2 years

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

Secondary outcomes

  1. Blood lipids

    Time frame: 2 years

    We will measure blood lipids including total cholesterol and HDL over the course of the study to calculate overall cardiovascular risk.

  2. General Cardiovascular Disease Risk

    Time frame: 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)

  3. Genomic predictors of blood pressure change

    Time frame: 6-, 12-, 18, and 24-month follow-up

    A systems approach to developing genomic models integrating clinical and genomic data.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 30, 2011
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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