Self-monitoring of Blood Pressure in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00717665
First received: July 15, 2008
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
High Blood Pressure
Device: Home blood pressure tele-management system.
Other: Usual care.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-monitoring of Blood Pressure in Primary Care in Older Diabetic Patients With Uncontrolled Systolic Hypertension

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • mean change in daytime diastolic BP on 24-hour ambulatory BP monitoring [ Time Frame: from the baseline to the last (12-month) visit ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • number and doses of different classes of antihypertensive medications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • average adherence rate with home BP monitoring [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • the number of adherence reminders in the tele-management group over the course of the study [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • the number of office visits of patients [ Time Frame: during the one year study period ] [ Designated as safety issue: Yes ]
  • determinants of adherence to tele-monitoring [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 110
Study Start Date: June 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717665

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Alexander G. Logan, MD, FRCP(C) Mount Sinai Hospital, New York
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Alexander Logan, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00717665     History of Changes
Other Study ID Numbers: ESA 5970
Study First Received: July 15, 2008
Last Updated: June 24, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Hypertension
Telemanagement
Home blood pressure monitoring
Self care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014