Self-monitoring of Blood Pressure in Primary Care

NCT00717665 | Completed

• 1 other identifier: ESA 5970
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 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.

Conditions

High Blood Pressure

Keywords

Hypertension; Telemanagement; Home blood pressure monitoring; Self care

Outcome Measures

Primary Outcomes (1)

• The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory.

  1 year

Secondary Outcomes (9)

• 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

• mean change in daytime diastolic BP on 24-hour ambulatory BP monitoring

  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

  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

  one year

• number and doses of different classes of antihypertensive medications

  one year

Study Arms (2)

A, 1, I

EXPERIMENTAL

Device: Home blood pressure tele-management system.

A, 2, I

ACTIVE COMPARATOR

Other: Usual care.

Interventions

Home blood pressure tele-management system. DEVICE

Scheduled blood pressure monitoring with transmission of information to a central server for processing and disbursement.

A, 1, I

Usual care. OTHER

Patient self-monitoring of blood pressure with results taken by patient to the doctor at scheduled visits.

A, 2, I

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (4)

• 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. doi: 10.1016/s0140-6736(03)14739-3.

  PMID: 14615107 BACKGROUND

• 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. doi: 10.1161/01.HYP.0000103630.72812.10. Epub 2003 Nov 24.

  PMID: 14638619 BACKGROUND

• 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. doi: 10.1016/j.amjhyper.2007.03.020.

  PMID: 17765133 BACKGROUND

• Logan AG, Irvine MJ, McIsaac WJ, Tisler A, Rossos PG, Easty A, Feig DS, Cafazzo JA. Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics. Hypertension. 2012 Jul;60(1):51-7. doi: 10.1161/HYPERTENSIONAHA.111.188409. Epub 2012 May 21.

  PMID: 22615116 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alexander G. Logan, MD, FRCP(C)

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: June 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

CA (1)