Hypertension Clinical Trial
Official title:
Take Control of Your Blood Pressure (TCYB)
The purpose of this study is to improve adherence to blood pressure (BP) monitoring and medication compliance in individuals with high BP.
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.
Additionally, a subset (n=250) of those enrolled and randomized to either the nurse
administered program or usual care will be evaluated separately on the programs's effect on
both primary (blood pressure control) and secondary outcome measures (changes in
hypertension risk perception,satisfaction with care, patient confidence following
recommended regimen, and self-reported adherence to recommended regimens.) Masking for this
is open label.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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