Self-monitoring of Blood Pressure in Primary Care

High Blood Pressure Clinical Trial

Official title: Self-monitoring of Blood Pressure in Primary Care in Older Diabetic Patients With Uncontrolled Systolic Hypertension

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

• NCT number: NCT00717665
• Study type: Interventional
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Completion date: June 2010