Status:
COMPLETED
Self-monitoring of Blood Pressure in Primary Care
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
High Blood Pressure
Eligibility:
All Genders
30+ years
Phase:
NA
Brief 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...
Detailed 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 foun...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes mellitus (the onset of diabetes must have occurred on or after the age of 30 years and there is no history of diabetic ketoacidosis)
- Uncontrolled systolic hypertension (defined as a daytime systolic BP of 130 mm Hg or higher on 24-hour ambulatory)
Exclusion
- Conditions making the patient unsuitable for study such as severe cognitive impairment, language difficulties (unable to speak and understand instructions in English), frequent (more than once per month for more than week) or prolonged (more than 2 months) trips away from home, homelessness, self-identified substance abuse, being pregnant, or unable to use home BP device;
- Life expectancy less than one year
- Coexisting conditions that require frequent (more than once a month) office visits or repeated (more than once in the past year) hospitalizations
- Atrial fibrillation or other cardiac arrhythmias requiring drug treatment
- Moderately severe chronic renal failure defined as estimated GFR less than 25 mL/min
- Myocardial infarction, episode of heart failure requiring hospitalization, or paralyzing stroke in the past year
- Having unstable angina
- Severe valvular heart diseases such as severe aortic stenosis
- Symptomatic orthostatic hypotension
- Refusal to sign consent form or to carry out the demands made by the study
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00717665
Start Date
June 1 2007
End Date
June 1 2010
Last Update
June 28 2011
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5