HypertensionNCT00374829
Impact of an IT-Based and Healthcare Professional Support Program on Patients With High Blood Pressure
A study testing An IT-based patient follow-up and reminder system in people with Hypertension, run by Université de Montréal at 1 site in Canada.
Trial summary
The study is a randomised controlled trial to evaluate the impact of a program using information technology (IT) and healthcare professional support in patients with high blood pressure (BP) compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- An IT-based patient follow-up and reminder system
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 223 participants
- Where
- 1 siteCanada
- Study dates
- May 2004to Jun 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with untreated or suboptimally controlled hypertension
- Age equal to or greater than 18 years
- Ambulatory outpatients currently being treated in primary care setting
- Capable of giving informed consent
- Able to communicate in and read either French or English
- Purchase their medication at a pharmacy participating in the program
Show all 9Show fewer
- Agree to stay with one pharmacy for the duration of the study
- Able to have a 24 hour ABPM recording within 7 days of screening
- Written informed consent obtained
Who cannot join
- Unlikely to complete study due to life-threatening disease or condition
- Having chronic atrial fibrillation
- Unable to use an ordinary telephone
- Pregnant at the initial visit
- Participating in another clinical trial concomitantly
- Participated in an antihypertensive clinical trial within the past 2 months
- Living with another subject that is currently participating in the study
- Delaying pharmacotherapy for baseline ABPM could put the subject at risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Multidisciplinary, Information Technology Supported Program on Blood Pressure Control in Primary Care (The Loyal Study)
The study is a randomised controlled trial to evaluate the impact of a program using information technology (IT) and healthcare professional support in patients with high blood pressure (BP) compared to usual care. The program helps patients monitor their own BP and medication and keeps nurses,physicians and pharmacists informed while respecting patient confidentiality. The IT system links directly with the patient's pharmacy data. Using pharmacy data and responses to questions on compliance and BP control, the IT system provides appropriate counselling, telephone reminders, generates prescription refill and renewal reminder calls and monitors BP. The system reports compliance and self recorded BP measurements to healthcare providers and also links with a nurse. This is so that the nurse, the patient's doctor and pharmacist can help answer questions about medication and controlling high blood pressure.
A total of 500 patients in Laval, Quebec will participate in the study. Half of the patients will have the program plus usual care and the other have usual care only. We hypothesize that the program will improve BP control by helping patients take their medication properly and by helping doctors ensure that the best strength and kinds of medication are used to control high blood pressure. We believe the program will achieve this by helping to improve communication between patients and healthcare providers, without adversely impacting quality of life. Additional sub-studies will determine if the program is cost effective and can be applied in real practice and if the program helps patients, doctors, pharmacists and nurses communicate better.
Read the detailed description
As the Canadian population ages, the number of hypertensive patients that have major cardiovascular events will increase, placing additional burden on healthcare resources. The positive effects of optimal blood pressure (BP) control on morbidity and mortality have been clearly established. In spite of this, data suggest that only 13% of Canadian hypertensive patients are adequately controlled. It is believed that much of this poor BP control can be attributed to: patient non-compliance; acceptance of inadequate BP control by clinicians; lower BP goals; and the fact that it is difficult to achieve adequate BP control with monotherapy in the majority of patients.
There is a recognised need to improve communication between patients and health care providers and among healthcare professionals themselves and to develop new tools to improve patients compliance. We have developed an information technology (IT)-based system to empower patients to be responsible for monitoring their blood pressure (BP) and compliance and to facilitate communication with healthcare providers. The IT-based system links with actual pharmacy prescription refill and renewal data. Using these data as well as responses to questions on compliance and BP control that patients provide using the telephone, the system: offers patients counselling and telephone reminders; generates prescription refill and renewal reminder calls; and, monitors patient recorded BP. The system generates monthly reports to the treating physician and pharmacist on compliance and blood pressure control, which we believe will help them monitor and modify therapy as appropriate. The system also links patients with a nurse if BP is inadequately controlled and/or if patients are non-compliant, who, in turn, can then provide appropriate counselling and refer the patients to their physician or pharmacist as appropriate.
The randomised controlled trial (RCT), is designed to determine if this multidisciplinary, information-technology supported hypertension management program (hereafter called "the intervention") will improve BP control. We hypothesise that the intervention will achieve this through enhanced compliance with pharmacotherapy by patients and the use of higher doses and more anti-hypertensive agents when appropriate, without adversely impacting quality of life. Additional sub-studies will be conducted to explore the perceptions patients, their families and healthcare providers have on the impact of the intervention on the process of care and to further explore the links between communication and relationship skills (CRS), compliance and health-care outcomes and to further evaluate collaborative models of inter-professional practice.
The primary outcome measure is to evaluate the impact of the intervention on the mean change in 24-hour systolic and diastolic BP levels measured using ABPM. Secondary objectives are to assess the likely mechanisms that account for the results for the primary objective by measuring: refill compliance to the BP lowering regimen, the number of dosage and/or type of medication changes over the 12-month study period and the time interval between prescriptions to initiate these changes, the number of different anti-hypertensive agents used and the number and nature of interventions by pharmacists, nurses and physicians. In addition average 24 hour and nocturnal diastolic and systolic blood pressure measurements using 24 hour continuous ABPM at 12-month follow-up; the proportion of subjects who achieve target BP according to the Canadian recommendations; the subject's health related quality of life at baseline and at 12-months; the cost-effectiveness of the system from a third party payer's perspective in terms of $ per QALY (derived from the EuroQoL) and $ per years of life gained, after modelling for long term reduction in events associated with better blood pressure control; the subject's acceptance or refusal of all or part of the IT-based reminder and blood pressure monitoring system; and, the physician's and subject's perception of the impact of the system on the process of care.
- Conditions
- Hypertension
- Being tested
- An IT-based patient follow-up and reminder system
- Keywords
- randomised prospective trial, medication refill compliance, hypertension, ambulatory blood pressure monitoring, information technology based patient support system, process of care, quality of life, pharmacoeconomics, multidisciplinary patient management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An IT-based patient follow-up and reminder systemBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean 24-hour systolic and diastolic BP using ABPM
Measured: 12 months
Secondary outcomes (8)
Refill compliance to the BP lowering regimen
Measured: 12 months
Dosage and/or type of medication changes
Measured: 12 months
Change in the mean daytime and nocturnal systolic and diastolic BP between baseline and 12 months measured using ABPM
Measured: 12 months
Proportion of subjects who achieve target BP
Measured: 12 months
Proportion of patients presenting with an adverse cardiovascular event
Measured: 12 months
The mean change in health related quality of life
Measured: 12 months
Number and nature of pharmacist, nurse and physician interventions
Measured: 12 months
Long-term cost-effectiveness of the system
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startMay 2004
- Study completionJun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Investigators
- Stéphane Rinfret, MD MSc FRCPC, Principal investigator, Centre de Recherche, Centre Hospitalier de l'Université de Montréal (CRCHUM)Pavel Hamet, MD PhD FRCPC, Study director, Centre de Recherche, Centre Hospitalier de l'Université de Montréal (CRCHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374829
- Sponsor's protocol ID
- NRA 0530008
- Other IDs
- ISRCTN75436659
- Status last verified
- May 2007
- First submitted
- 8 Sep 2006
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rinfret S, Lussier MT, Peirce A, Duhamel F, Cossette S, Lalonde L, Tremblay C, Guertin MC, LeLorier J, Turgeon J, Hamet P; LOYAL Study Investigators. The impact of a multidisciplinary information technology-supported program on blood pressure control in primary care. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):170-7. doi: 10.1161/CIRCOUTCOMES.108.823765. Epub 2009 May 5.
PubMed 20031834
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Multidisciplinary, Information Technology Supported Program on Blood Pressure Control in Primary Care (The Loyal Study)
- ClinicalTrials.gov ID
- NCT00374829
- Acronym / sponsor ID
- NRA 0530008
- Conditions
- Hypertension
- Keywords
- randomised prospective trial, medication refill compliance, hypertension, ambulatory blood pressure monitoring, information technology based patient support system, process of care, quality of life, pharmacoeconomics, multidisciplinary patient management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pfizer
- Study start
- May 2004
- Study completion
- Jun 2007 (estimated)
- First posted
- 12 Sep 2006 (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.
The study is a randomised controlled trial to evaluate the impact of a program using information technology (IT) and healthcare professional support in patients with high blood pressure (BP) compared to usual care. The program helps patients monitor their own BP and medication and keeps nurses,physicians and pharmacists informed while respecting patient confidentiality. The IT system links directly with the patient's pharmacy data. Using pharmacy data and responses to questions on compliance and BP control, the IT system provides appropriate counselling, telephone reminders, generates prescription refill and renewal reminder calls and monitors BP. The system reports compliance and self recorded BP measurements to healthcare providers and also links with a nurse. This is so that the nurse, the patient's doctor and pharmacist can help answer questions about medication and controlling high blood pressure.
A total of 500 patients in Laval, Quebec will participate in the study. Half of the patients will have the program plus usual care and the other have usual care only. We hypothesize that the program will improve BP control by helping patients take their medication properly and by helping doctors ensure that the best strength and kinds of medication are used to control high blood pressure. We believe the program will achieve this by helping to improve communication between patients and healthcare providers, without adversely impacting quality of life. Additional sub-studies will determine if the program is cost effective and can be applied in real practice and if the program helps patients, doctors, pharmacists and nurses communicate better.
Detailed description
As the Canadian population ages, the number of hypertensive patients that have major cardiovascular events will increase, placing additional burden on healthcare resources. The positive effects of optimal blood pressure (BP) control on morbidity and mortality have been clearly established. In spite of this, data suggest that only 13% of Canadian hypertensive patients are adequately controlled. It is believed that much of this poor BP control can be attributed to: patient non-compliance; acceptance of inadequate BP control by clinicians; lower BP goals; and the fact that it is difficult to achieve adequate BP control with monotherapy in the majority of patients.
There is a recognised need to improve communication between patients and health care providers and among healthcare professionals themselves and to develop new tools to improve patients compliance. We have developed an information technology (IT)-based system to empower patients to be responsible for monitoring their blood pressure (BP) and compliance and to facilitate communication with healthcare providers. The IT-based system links with actual pharmacy prescription refill and renewal data. Using these data as well as responses to questions on compliance and BP control that patients provide using the telephone, the system: offers patients counselling and telephone reminders; generates prescription refill and renewal reminder calls; and, monitors patient recorded BP. The system generates monthly reports to the treating physician and pharmacist on compliance and blood pressure control, which we believe will help them monitor and modify therapy as appropriate. The system also links patients with a nurse if BP is inadequately controlled and/or if patients are non-compliant, who, in turn, can then provide appropriate counselling and refer the patients to their physician or pharmacist as appropriate.
The randomised controlled trial (RCT), is designed to determine if this multidisciplinary, information-technology supported hypertension management program (hereafter called "the intervention") will improve BP control. We hypothesise that the intervention will achieve this through enhanced compliance with pharmacotherapy by patients and the use of higher doses and more anti-hypertensive agents when appropriate, without adversely impacting quality of life. Additional sub-studies will be conducted to explore the perceptions patients, their families and healthcare providers have on the impact of the intervention on the process of care and to further explore the links between communication and relationship skills (CRS), compliance and health-care outcomes and to further evaluate collaborative models of inter-professional practice.
The primary outcome measure is to evaluate the impact of the intervention on the mean change in 24-hour systolic and diastolic BP levels measured using ABPM. Secondary objectives are to assess the likely mechanisms that account for the results for the primary objective by measuring: refill compliance to the BP lowering regimen, the number of dosage and/or type of medication changes over the 12-month study period and the time interval between prescriptions to initiate these changes, the number of different anti-hypertensive agents used and the number and nature of interventions by pharmacists, nurses and physicians. In addition average 24 hour and nocturnal diastolic and systolic blood pressure measurements using 24 hour continuous ABPM at 12-month follow-up; the proportion of subjects who achieve target BP according to the Canadian recommendations; the subject's health related quality of life at baseline and at 12-months; the cost-effectiveness of the system from a third party payer's perspective in terms of $ per QALY (derived from the EuroQoL) and $ per years of life gained, after modelling for long term reduction in events associated with better blood pressure control; the subject's acceptance or refusal of all or part of the IT-based reminder and blood pressure monitoring system; and, the physician's and subject's perception of the impact of the system on the process of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female with untreated or suboptimally controlled hypertension
- Age equal to or greater than 18 years
- Ambulatory outpatients currently being treated in primary care setting
- Capable of giving informed consent
- Able to communicate in and read either French or English
Key exclusion criteria (8 listed)
- Unlikely to complete study due to life-threatening disease or condition
- Having chronic atrial fibrillation
- Unable to use an ordinary telephone
- Pregnant at the initial visit
- Participating in another clinical trial concomitantly
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 |
|---|---|---|
| An IT-based patient follow-up and reminder system | Behavioural | – |
Primary outcome
Change in the mean 24-hour systolic and diastolic BP using ABPM
Time frame: 12 months
8 secondary outcomes
Refill compliance to the BP lowering regimen
Time frame: 12 months
Dosage and/or type of medication changes
Time frame: 12 months
Change in the mean daytime and nocturnal systolic and diastolic BP between baseline and 12 months measured using ABPM
Time frame: 12 months
Proportion of subjects who achieve target BP
Time frame: 12 months
Proportion of patients presenting with an adverse cardiovascular event
Time frame: 12 months
The mean change in health related quality of life
Time frame: 12 months
Number and nature of pharmacist, nurse and physician interventions
Time frame: 12 months
Long-term cost-effectiveness of the system
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
- Derived from this study: PubMed 20031834Rinfret S, Lussier MT, Peirce A, Duhamel F, Cossette S, Lalonde L, Tremblay C, Guertin MC, LeLorier J, Turgeon J, Hamet P; LOYAL Study Investigators. The impact of a multidisciplinary information technology-supported program on blood pressure control in primary care. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):170-7. doi: 10.1161/CIRCOUTCOMES.108.823765. Epub 2009 May 5.
- ISRCTN RegisterLink provided by the sponsor.
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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.
Stéphane Rinfret, MD MSc FRCPC principal investigator
Centre de Recherche, Centre Hospitalier de l'Université de Montréal (CRCHUM)
Pavel Hamet, MD PhD FRCPC study director
Centre de Recherche, Centre Hospitalier de l'Université de Montréal (CRCHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An IT-based patient follow-up and reminder system in people with Hypertension, run by Université de Montréal 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 May 2009. 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?
Results are not available in the source record.
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?
Change in the mean 24-hour systolic and diastolic BP using ABPM (time frame: 12 months). 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 NCT00374829, which also lists 1 linked publication.
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 8 May 2009.