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| [ ...Back to search results ] | [ Print-friendly version ] |
| Ambulatory integrated primary care management program for patients with dyslipidaemia |
| ISRCTN | ISRCTN66345533 |
| ClinicalTrials.gov identifier | |
| Public title | Ambulatory integrated primary care management program for patients with dyslipidaemia |
| Scientific title | Randomised controlled trial to evaluate an ambulatory integrated primary care management program for patients with dyslipidaemia: TEAM Study |
| Acronym | TEAM |
| Serial number at source | MCT-75427 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Dyslipidaemia |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2006 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 224 |
| 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 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. |
| Primary outcome measure(s) | Mean change in LDL-C from baseline to month 12 |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75427) |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20212029 |
| Contact name | Dr Lyne Lalonde |
| Address |
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 |
| City/town | Laval, Quebec |
| Zip/Postcode | H7M 3L9 |
| Country | Canada |
| Tel | +1 514 343 6111 ext. 5315 |
| Fax | +1 514 343 5691 |
| lyne.lalonde@umontreal.ca | |
| Sponsor | University of Montreal (Canada) |
| Address |
Faculté de Pharmacie
Université de Montréal C.P. 6128 Succursale Centre-ville |
| City/town | Montreal, Quebec |
| Zip/Postcode | H3C 3J7 |
| Country | Canada |
| Tel | +1 514 343 7497 |
| sophie.brisbois@umontreal.ca | |
| Sponsor website: | http://www.umontreal.ca/english/ |
| Date applied | 09/08/2005 |
| Last edited | 16/04/2010 |
| Date ISRCTN assigned | 09/08/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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