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Ambulatory integrated primary care management program for patients with dyslipidaemia

Randomised controlled trial to evaluate an ambulatory integrated primary care management program for patients with dyslipidaemia: TEAM Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66345533
Enrollment
224
Registered
2005-08-09
Start date
2006-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemia Nutritional, Metabolic, Endocrine Dyslipidaemia

Interventions

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

Sponsors

University of Montreal (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Mean change in LDL-C from baseline to month 12

Secondary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026