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.
Status | Completed |
Enrollment | 110 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Heart and Stroke Foundation of Ontario |
Canada,
Logan AG, McIsaac WJ, Tisler A, Irvine MJ, Saunders A, Dunai A, Rizo CA, Feig DS, Hamill M, Trudel M, Cafazzo JA. Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients. Am J Hypertens. 2007 Sep;20(9):942-8. — View Citation
Turnbull F; Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. Lancet. 2003 Nov 8;362(9395):1527-35. — View Citation
Wolf-Maier K, Cooper RS, Kramer H, Banegas JR, Giampaoli S, Joffres MR, Poulter N, Primatesta P, Stegmayr B, Thamm M. Hypertension treatment and control in five European countries, Canada, and the United States. Hypertension. 2004 Jan;43(1):10-7. Epub 2003 Nov 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. | 1 year | Yes | |
Secondary | mean change in systolic and diastolic BP on 24-hour ambulatory and one-week home BP monitoring | from the baseline to the last (12-month) visit | Yes | |
Secondary | mean change in daytime diastolic BP on 24-hour ambulatory BP monitoring | from the baseline to the last (12-month) visit | Yes | |
Secondary | mean change in systolic and diastolic BP during the sleep period on 24-hour ambulatory BP monitoring | from the baseline to the last (12-month) visit | Yes | |
Secondary | 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 | one year | Yes | |
Secondary | number and doses of different classes of antihypertensive medications | one year | Yes | |
Secondary | average adherence rate with home BP monitoring | one year | Yes | |
Secondary | the number of adherence reminders in the tele-management group over the course of the study | one year | Yes | |
Secondary | the number of office visits of patients | during the one year study period | Yes | |
Secondary | determinants of adherence to tele-monitoring | one year | Yes |
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