Impact of an IT-Based and Healthcare Professional Support Program on Patients With High Blood Pressure
The Impact of a Multidisciplinary, Information Technology Supported Program on Blood Pressure Control in Primary Care (The Loyal Study)
2 other identifiers
interventional
223
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started May 2004
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2006
CompletedFirst Posted
Study publicly available on registry
September 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMay 8, 2009
May 1, 2007
September 8, 2006
May 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the mean 24-hour systolic and diastolic BP using ABPM
12 months
Secondary Outcomes (8)
Refill compliance to the BP lowering regimen
12 months
Dosage and/or type of medication changes
12 months
Change in the mean daytime and nocturnal systolic and diastolic BP between baseline and 12 months measured using ABPM
12 months
Proportion of subjects who achieve target BP
12 months
Proportion of patients presenting with an adverse cardiovascular event
12 months
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Université de Montréallead
- Canadian Institutes of Health Research (CIHR)collaborator
- Pfizercollaborator
Study Sites (1)
Cité de la Santé de Laval
Laval, Quebec, H7M 3L9, Canada
Related Publications (1)
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.
PMID: 20031834DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane Rinfret, MD MSc FRCPC
Centre de Recherche, Centre Hospitalier de l'Université de Montréal (CRCHUM)
- STUDY DIRECTOR
Pavel Hamet, MD PhD FRCPC
Centre de Recherche, Centre Hospitalier de l'Université de Montréal (CRCHUM)
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
September 8, 2006
First Posted
September 12, 2006
Study Start
May 1, 2004
Study Completion
June 1, 2007
Last Updated
May 8, 2009
Record last verified: 2007-05