Contact information
Type
Scientific
Primary contact
Dr Lyne Lalonde
ORCID ID
Contact details
Équipe de recherche
Soins de première ligne
Centre de santé et de services sociaux
de Laval (Cité de la Santé de Laval)
1755 René-Laennec
local D-S145
Laval
Quebec
H7M 3L9
Canada
+1 514 343 6111 ext. 5315
lyne.lalonde@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-75427
Study information
Scientific title
Randomised controlled trial to evaluate an ambulatory integrated primary care management program for patients with dyslipidaemia: TEAM Study
Acronym
TEAM
Study hypothesis
Compared to the usual care (UC) patients, those assigned to the integrated primary care (IPC) intervention will have a larger reduction in low-density lipoprotein cholesterol (LDL-C) and more patients will achieve the recommended target lipid levels.
Ethics approval
Ethics and research committee of the Laval Health and Social Service Centre gave approval on the 19th October 2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Dyslipidaemia
Intervention
In the integrated primary care (IPC) intervention, family physicians will be responsible for the diagnosis and prescription of the statin treatment. Thereafter, the pharmacists will be responsible for monitoring the effectiveness and safety of the treatment. They will be allowed to request laboratory tests at predetermined time intervals and perform protocol-driven dosage adjustments.
In the usual care (UC) intervention, physicians and pharmacists will receive no instructions regarding the type and frequency of patient visits.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Mean change in LDL-C from baseline to month 12
Secondary outcome measures
1. Achievement of the recommended target lipid levels, TC, HDL-C, TC/HDL-C, triglyceride, blood pressure, body mass index, fasting blood glucose, adherence and persistence to statin treatment, patient satisfaction, knowledge and decisional conflict, professionals' satisfaction
2. Application of the IPC intervention
Overall trial start date
01/02/2006
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than or equal to 18 years, either sex
2. Speak and read French or English
3. Are able to give informed consent and understand and follow study procedures
4. Agree to participate and sign the informed consent
5. According to the results of their last laboratory tests (performed in the previous three months), are candidate for initiating statin monotherapy or are currently on statin monotherapy at a non-optimal dose and are not adequately controlled according to one of the following criteria:
5.1. High risk (10-year coronary heart disease [CHD] risk greater than 20%): LDL-C greater than 2.5 mmol/l and total cholesterol (TC):high-density lipoprotein (HDL-C) ratio greater than 4
5.2. Moderate risk (10-year CHD risk between 11 - 19%): LDL-C greater than 3.5 mmol/l and TC:HDL-C ratio greater than 5
6. Agree to be followed by one of the participating family physicians and one of the pharmacists for the duration of the study (12 months)
7. IPC physician agrees to refer the patient to a participating pharmacist for dyslipidaemia-treatment follow-up
8. Physician agrees to delay the beginning or change of pharmacotherapy until the initial study visit
9. Patients are not patients of a particular pharmacy or report being patients of one of the participating pharmacies
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
224
Participant exclusion criteria
1. Patients already taking lipid-lowering medication and adequately controlled according to the most recent Canadian guidelines for the treatment of dyslipidaemia
2. Patients taking more than one lipid-lowering medication
3. Patients with acute cardiovascular disease (CVD) event (e.g. myocardial infarction, stroke and revascularisation) in the previous 6 months
4. Patients with a life-threatening disease or another health condition (severe mental problems, chronic alcoholism, renal insufficiency [creatinine clearance less than 60 ml/min], hepatic insufficiency [aspartate aminotransferase {AST}, alanine aminotransferase {ALT} greater than 3 x the upper normal limit] etc.) that, according to the referring physician, make them unlikely to complete the study
5. Patient with triglyceride greater than 5 mmol/l
6. Patient with LDL-C greater than 5 mmol/l
7. Patient with contraindication to statin medication (elevated transaminase levels [AST or ALT greater than 3 x the upper normal limit], history of myalgia with creatinine kinase [CK] greater than 10 x the upper normal limit)
8. Participating in another clinical trial
Recruitment start date
01/02/2006
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Équipe de recherche
Laval, Quebec
H7M 3L9
Canada
Sponsor information
Organisation
University of Montreal (Canada)
Sponsor details
Faculté de Pharmacie
Université de Montréal
C.P. 6128
Succursale Centre-ville
Montreal
Quebec
H3C 3J7
Canada
+1 514 343 7497
sophie.brisbois@umontreal.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75427)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20212029
Publication citations
-
Results
Villeneuve J, Genest J, Blais L, Vanier MC, Lamarre D, Fredette M, Lussier MT, Perreault S, Hudon E, Berbiche D, Lalonde L, A cluster randomized controlled Trial to Evaluate an Ambulatory primary care Management program for patients with dyslipidemia: the TEAM study., CMAJ, 2010, 182, 5, 447-455, doi: 10.1503/cmaj.090533.