High Blood PressureNCT00717665
Self-monitoring of Blood Pressure in Primary Care
A study testing Home blood pressure tele-management system. in people with High Blood Pressure, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Home blood pressure tele-management system.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- High Blood Pressure
- Being tested
- Home blood pressure tele-management system., Usual care.
- Keywords
- Hypertension, Telemanagement, Home blood pressure monitoring, Self care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home blood pressure tele-management system.Device
Scheduled blood pressure monitoring with transmission of information to a central server for processing and disbursement.
Usual care.Other
Patient self-monitoring of blood pressure with results taken by patient to the doctor at scheduled visits.
| Study group | Role | What they receive |
|---|---|---|
| A, 1, I | Experimental | Not described Receives: Device: Home blood pressure tele-management system. |
| A, 2, I | Active comparator | Not described Receives: Other: Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory.
Measured: 1 year
Secondary outcomes (9)
mean change in systolic and diastolic BP on 24-hour ambulatory and one-week home BP monitoring
Measured: from the baseline to the last (12-month) visit
mean change in daytime diastolic BP on 24-hour ambulatory BP monitoring
Measured: 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
Measured: 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
Measured: one year
number and doses of different classes of antihypertensive medications
Measured: one year
average adherence rate with home BP monitoring
Measured: one year
the number of adherence reminders in the tele-management group over the course of the study
Measured: one year
the number of office visits of patients
Measured: during the one year study period
determinants of adherence to tele-monitoring
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- Alexander G. Logan, MD, FRCP(C), Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717665
- Sponsor's protocol ID
- ESA 5970
- Status last verified
- Jun 2011
- First submitted
- 15 Jul 2008
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14615107Wolf-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.
PubMed 14638619Logan 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.
PubMed 17765133Logan 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.
PubMed 22615116
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-monitoring of Blood Pressure in Primary Care in Older Diabetic Patients With Uncontrolled Systolic Hypertension
- ClinicalTrials.gov ID
- NCT00717665
- Acronym / sponsor ID
- ESA 5970
- Conditions
- High Blood Pressure
- Keywords
- Hypertension, Telemanagement, Home blood pressure monitoring, Self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1, I | Experimental | Device: Home blood pressure tele-management system. |
| A, 2, I | Active comparator | Other: Usual care. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home blood pressure tele-management system.Scheduled blood pressure monitoring with transmission of information to a central server for processing and disbursement. | Device | A, 1, I |
| Usual care.Patient self-monitoring of blood pressure with results taken by patient to the doctor at scheduled visits. | Other | A, 2, I |
Primary outcome
The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory.
Time frame: 1 year
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Background: PubMed 14615107Turnbull 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.
- Background: PubMed 14638619Wolf-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.
- Background: PubMed 17765133Logan 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.
- Derived from this study: PubMed 22615116Logan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander G. Logan, MD, FRCP(C) principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home blood pressure tele-management system. in people with High Blood Pressure, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00717665, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.