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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00123058 |
The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.
Condition | Intervention |
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Cardiovascular Diseases Heart Diseases Hypertension |
Behavioral: Health Education Program Device: BP Monitor |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Take Control of Your Blood Pressure (TCYB) |
Enrollment: | 636 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
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Nurse administered: Experimental
Subject received nurse administered behavioral intervention every 8 weeks via telephone for 24 months.
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Behavioral: Health Education Program
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
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Nurse & BP monitor: Experimental
Subjects received both a nurse administered behavioral intervention via telephone every 8 weeks for 24 months and a study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
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Behavioral: Health Education Program
Subjects received a nurse administered behavioral intervention via telephone every 8 weeks for 24 months.
Device: BP Monitor
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
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Usual Care: No Intervention
Subjects received neither home BP monitor nor nurse phone intervention.
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Home BP Monitor: Experimental
Subject received study provided home BP monitor. Subject recorded home BP 3 times per week for 24 months.
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Device: BP Monitor
Subjects received a study provided home BP monitor and recorded home BP 3 times per week for 24 months.
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BACKGROUND:
High BP is a major health problem, which contributes to high levels of morbidity and mortality. Elevated BP levels are a major risk factor for stroke, coronary artery disease (CAD), congestive heart failure (CHF), and kidney disease. In the United States, stroke rates are no longer improving and CHF and kidney failure rates continue to increase. Despite the availability of effective treatment, only 25% of individuals with high BP are able to control it effectively. The reasons for poor BP control vary; however, a predominant reason is poor adherence to medication instructions and life-style modification recommendations. This study will address these two sources of poor BP control through a real world, multifaceted approach.
DESIGN NARRATIVE:
This study will compare a nurse-administered tailored program to a home BP monitoring program to evaluate the impact each program has on BP control. The 5-year randomized controlled study will take place in a primary care setting and will enroll individuals with high BP. The nurse-administered program will be based on the principles of the Health Decision Model and will be designed to increase awareness, yet be easily integrated into the participant's medical care so as to enhance adherence with the prescribed treatment. The use of home BP monitors has been found to be associated with increased self management, medication adherence, and improved BP control.
Five hundred seventy individuals with high BP from two primary care clinics will be randomly assigned to receive either the nurse-administered program, home BP monitoring program, both programs, or regular medical care. Based on an initial assessment, participants assigned to the nurse-administered program will be involved in a behavioral education telephone program to promote medication adherence. This program will include support, reminders, and information on the risks of high BP, health behaviors, patient/doctor communication, literacy, and side effects. Participants will receive continuous education and will be monitored and supported to enhance medication adherence. Participants assigned to the home BP monitors will record their BP every other day and mail the results to the study physicians. The primary outcome will be whether or not the participant's BP is greater than 140/90 mm Hg (for non-diabetic individuals) or greater than 130/85 mm Hg (for diabetic individuals) at 6-month intervals over 24 months (5 total measurements). Descriptive statistics will be computed for all study variables stratified by treatment group. Because each participant may have a different number of measurements, the study physicians will model the responses and evaluate the programs using a mixed effects model for dichotomous outcomes. Based upon preliminary data, this study will improve participants' management of high BP, decrease health care utilization, and subsequently improve BP control.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Duke University Medical Center ( Hayden B. Bosworth, PhD ) |
Study ID Numbers: | 233, R01 HL70713 |
Study First Received: | July 20, 2005 |
Last Updated: | December 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00123058 |
Health Authority: | United States: Federal Government |
Heart Diseases Vascular Diseases Hypertension |
Cardiovascular Diseases |