High Blood Pressure Clinical Trial
Official title:
Self-monitoring of Blood Pressure in Primary Care in Older Diabetic Patients With Uncontrolled Systolic Hypertension
This study is an open randomized controlled trial of 12-month duration, which compares the use of a home blood pressure (BP) tele-management system to the usual approach of home BP monitoring in older diabetic patients with uncontrolled systolic hypertension. The purpose of this study is to determine whether home blood pressure tele-management system will markedly improve blood pressure control in a primary care setting.
Hypertension is a major risk factor for renal and cardiovascular disease (CVD). While the
health benefits of lowering blood pressure (BP) are well documented, population surveys have
consistently found that less than a quarter of hypertensive patients have their BP under
good control. Self-monitoring of BP at home has been extensively evaluated as a potentially
useful tool to improve BP control and medication adherence in hypertensive patients.
We developed a user-centric home BP tele-management system. The system captures all home
self-measured BP readings and requires patients to set jointly with their physician their BP
treatment goal, home BP monitoring schedule and BP alert levels. The system tracks the
frequency, date and time of home readings, generates messages for patients and reports for
physicians indicating whether the BP treatment goal has been reached, and sends BP alerts
and adherence reminders for BP readings to patients and clinical BP alerts and reports to
physicians. Using an open, randomized controlled parallel group trial design, older diabetic
patients with uncontrolled systolic hypertension, recruited from the practice of primary
care physicians, will receive either usual care approach to home BP monitoring or care that
incorporates the use of the home BP tele-management system. The primary outcome measure is
the change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour
ambulatory. The secondary objective is to examine the psychosocial factors that may make it
difficult for some patients to monitor their blood pressure at home. The rationale for
including a psychological component in the study is that a critical component of the system
is adherence to self-monitoring. While adherence can be automatically determined through the
telemanagement system, the determinants of adherence to this behaviour have not been
adequately assessed in the literature. To gain insights into this aspect of health behaviour
we will measure psychological predictors using quantitative and qualitative techniques.
Moreover, monitoring adherence with home BP monitoring will provide a proxy measure of
acceptance of the system as a poor adherence rate would suggest that patients perceive it as
a futile exercise, not leading to any changes in their care.
This study tests a novel approach to treat hypertension, a major health problem in diabetic
patients. The information from this study will be invaluable for future health care
planning.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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