Self-monitoring of Blood Pressure in Primary Care
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|ClinicalTrials.gov Identifier: NCT00717665|
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : June 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|High Blood Pressure||Device: Home blood pressure tele-management system. Other: Usual care.||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Self-monitoring of Blood Pressure in Primary Care in Older Diabetic Patients With Uncontrolled Systolic Hypertension|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
|Experimental: A, 1, I||
Device: Home blood pressure tele-management system.
Scheduled blood pressure monitoring with transmission of information to a central server for processing and disbursement.
|Active Comparator: A, 2, I||
Other: Usual care.
Patient self-monitoring of blood pressure with results taken by patient to the doctor at scheduled visits.
- The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. [ Time Frame: 1 year ]
- mean change in systolic and diastolic BP on 24-hour ambulatory and one-week home BP monitoring [ Time Frame: from the baseline to the last (12-month) visit ]
- mean change in daytime diastolic BP on 24-hour ambulatory BP monitoring [ Time Frame: from the baseline to the last (12-month) visit ]
- mean change in systolic and diastolic BP during the sleep period on 24-hour ambulatory BP monitoring [ Time Frame: from the baseline to the last (12-month) visit ]
- the proportion of patients at systolic BP goal, defined as <130 mmHg and diastolic BP goal, defined as <80 mm Hg, based on the 24-hour ambulatory BP and one-week home BP monitoring recording [ Time Frame: one year ]
- number and doses of different classes of antihypertensive medications [ Time Frame: one year ]
- average adherence rate with home BP monitoring [ Time Frame: one year ]
- the number of adherence reminders in the tele-management group over the course of the study [ Time Frame: one year ]
- the number of office visits of patients [ Time Frame: during the one year study period ]
- determinants of adherence to tele-monitoring [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717665
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Alexander G. Logan, MD, FRCP(C)||Mount Sinai Hospital, New York|