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| Name | Class |
|---|---|
| The League of Clinical Research, Russia | OTHER |
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A systematic collection of retrospective and prospective data based on non-intervention patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases:
The research program will have two parts:
Stage1: identification of patients with moderate, high and very high cardiovascular risks, not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs.
Stage 2: a prospective observation of patients receiving primary medical prophylaxis of CVD with atorvastatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extended statin counseling group | Experimental | Extended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders. |
|
| convetional statin counseling group | No Intervention | Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended counseling | Behavioral | Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months | The primary objective of this study is to assess the influence of routing and extended statin counseling of patients with cardiovascular risk factors on the change in the percentage of patients who achieved target LDL cholesterol level from baseline through 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the effect of routing and extended statin counseling on changes in treatment adherence | The method used to measure adherence included the Morisky Medication Adherence Scale (MMAS - 4). Morisky Medication Adherence Scale is 4- item self-reported scale measuring medication taking behavior. Scores are transformed to a range of 0-4, in which higher scores reflect better adherence | Baseline and Month 12 |
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Inclusion Criteria:
Men and women 40-65 years old with the presence of:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oxana M Drapkina, MD, PhD | Director of National Medical Research Center for Preventive Medicine, Moscow | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention | Astrakhan | Russia | ||||
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Change from baseline in lipid levels (mmol/l) | To evaluate the impact of extended statin counseling on change of CVD risk factors (lipid levels) in patients with moderate, high and very high risk. Measurement of lipid levels at baseline and after 3,6,12 months | Baseline, Month 3, Month 6 and Month 12 |
| Change from baseline in blood pressure (mm Hg) | To evaluate the impact of standard and extended counseling on change of CVD risk factors (blood pressure). Measurement of blood pressure (mm Hg) at baseline and after 3,6,12 months | Baseline, Month 3, Month 6 and Month 12 |
| Impact of standard and extended counseling on statin therapy adherence | The method used to measure adherence was KAP test. KAP test is the specially designed questionnaire for this study includes 14 questions, in patients with hyperlipidemia. KAP test summary score is an assessment of patients' knowledge about high cholesterol, their attitude to this problem and the application of this knowledge. Higher scores reflect better indicators of knowledge, attitudes and practices | Baseline and Month 12 |
| Nizhny Novgorod Regional Center for Medical Prevention |
| Nizhny Novgorod |
| Russia |
| Regional Center for Medical Prevention | Novosibirsk | Russia |
| Samara Regional Center for Medical Prevention | Samara | Russia |
| Republican Center for Medical Prevention of the Republic of Bashkortostan | Ufa | Russia |