Water-Related Diseases |
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Clinical Trial: Take Control of Your Blood Pressure (TCYB)
This study is currently recruiting patients.
Purpose
| Condition | Intervention |
|---|---|
| Cardiovascular Diseases Heart Diseases Hypertension | Behavior: health education |
MedlinePlus related topics: Heart Diseases; High Blood Pressure; Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized
Study start: June 2003; Expected completion: May 2008
BACKGROUND: Hypertension is a major health problem, contributing to high levels of morbidity and mortality. Despite the availability of effective treatment, only approximately 25 percent of patients with hypertension realize effective blood pressure control. The reasons for poor blood pressure control vary, however a predominant reason is poor adherence to medication instructions and to recommendations for life-style modification. The study addresses these two sources of poor blood pressure control through a real world, multifaceted approach.
DESIGN NARRATIVE: The study 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, coronary artery disease (CAD), congestive heart failure (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.
The investigators 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, both interventions, 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, the investigators 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.
Eligibility
Location and Contact Information
North Carolina
Duke University Medical Center, Durham, North Carolina, 27705, United States; Recruiting
Hayden B. Bosworth, Study Chair
Hayden Bosworth, Duke University
More Information
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00123058
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26

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