The goal of this study is to improve patients' management of their hypertension. We will examine the impact of a nurse administered tailored intervention and home blood pressure (BP) monitor on BP control. This 5-year randomized controlled trial will occur in a primary care setting among diagnosed hypertensive patients. The nurse-administered intervention is based on the principles of the Health Decision Model and is designed to increase awareness, yet be easily implemented in patient care so as to enhance adherence with the prescribed regimen. The use of home BP monitors has been found to be associated with increased self management, adherence, and improved BP control. Elevated BP levels are a major risk factor for stroke, CAD, CHF, and renal disease. However, stroke rates are no longer improving and CHF and renal failure continue to increase in the U.S. Despite the high prevalence of hypertension, only approximately 25 percent of all hypertensive patients have adequate BP control. This study will be an important step in testing the effectiveness of both a nurse and self-administered intervention to improve BP control in a community sample of hypertensive patients. We will obtain consent from 570 hypertensive patients from 2 large primary care clinics and randomly assign them to receive the nurse intervention alone, home monitoring alone, bothinterventions, or usual care. Based on baseline needs assessment, patients randomized to the nurse-administered tailored intervention will receive a telephone behavioral education intervention to promote adherence with medication, including support and reminders, information on the risks of hypertension, health behaviors, patient/provider communication, literacy, and side effects at periodic telephone contacts. Patients will receive continuous patient education and will be monitored and supported to enhance adherence. Patients assigned to the home BP monitors will record their BP every other day and mail this material to the investigators. The primary outcome will be dichotomous, representing whether or not the patient's BP is > 140/90 mm/Hg (non-diabetic) and >130/85 mm/Hg (diabetics) at six month interval outpatient measurements over 24 months (5 total measurements). Descriptive statistics will be computed for all study variables stratified by treatment group. Because each patient may have a different number of observations over time, we will model the responses and evaluate the interventions using a mixed effects model for dichotomous outcomes. Based upon preliminary data, this study is expected to improve patients' management of their hypertension, decrease health care utilization and subsequently improve BP control.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
1R01HL070713-01A1
Application #
6617647
Study Section
Special Emphasis Panel (ZRG1-RPHB-2 (01))
Program Officer
Jobe, Jared B
Project Start
2003-06-01
Project End
2007-05-31
Budget Start
2003-06-01
Budget End
2004-05-31
Support Year
1
Fiscal Year
2003
Total Cost
$715,640
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
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Reed, Shelby D; Li, Yanhong; Oddone, Eugene Z et al. (2010) Economic evaluation of home blood pressure monitoring with or without telephonic behavioral self-management in patients with hypertension. Am J Hypertens 23:142-8
Bosworth, Hayden B; Olsen, Maren K; Grubber, Janet M et al. (2009) Two self-management interventions to improve hypertension control: a randomized trial. Ann Intern Med 151:687-95
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Bosworth, Hayden B; Powers, Benjamin; Grubber, Janet M et al. (2008) Racial differences in blood pressure control: potential explanatory factors. J Gen Intern Med 23:692-8
Bosworth, Hayden B; Voils, Corrine I; Potter, Guy G et al. (2008) The effects of antidepressant medication adherence as well as psychosocial and clinical factors on depression outcome among older adults. Int J Geriatr Psychiatry 23:129-34
Bosworth, Hayden B; Olsen, Maren K; Neary, Alice et al. (2008) Take Control of Your Blood Pressure (TCYB) study: a multifactorial tailored behavioral and educational intervention for achieving blood pressure control. Patient Educ Couns 70:338-47

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