Primary Prevention Program (3P)
The Program to Assess the Influence of Routing and Extended Statin Counseling of Patient With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance
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 retrospective part: database of patients with cardiovascular risks;
- the prospective part: observation of patients in the real medical practice
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Astrakhan、ロシア連邦
- Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention
-
Nizhny Novgorod、ロシア連邦
- Nizhny Novgorod Regional Center for Medical Prevention
-
Novosibirsk、ロシア連邦
- Regional Center for Medical Prevention
-
Samara、ロシア連邦
- Samara Regional Center for Medical Prevention
-
Ufa、ロシア連邦
- Republican Center for Medical Prevention of the Republic of Bashkortostan
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Men and women 40-65 years old with the presence of:
- moderate cardiovascular risk (<5% but ≥1% on a SCORE scale) and cholesterol level LDL ≥3.0 mmol / l, in which the target is not reached during the improvement of lifestyle level of cholesterol-LDL, and the attending physician considers appropriate the appointment lipid-lowering drugs (statins), or
- high cardiovascular risk (≥5% but <10% on a SCORE scale) and cholesterol level LDL ≥ 2.5 mmol / l, or
- very high cardiovascular risk (≥10% on the SCORE scale) and cholesterol-LDL ≥1.8mmol / l, or
- atherosclerotic stenosis of the brachiocephalic arteries> 50% in the absence cerebrovascular diseases and the level of cholesterol-LDL ≥1.8 mmol / l, which do not have contraindications to taking statins and not taking drugs of this group in currently.
Exclusion Criteria:
- The presence of the following clinically significant events in anamnesis: myocardial infarction, stroke, myocardial infarction
- The presence of the following diseases at the time of statin administration: ischemic heart disease; heart failure; atherosclerotic disease of peripheral arteries; atherosclerotic stenosis of the brachiocephalic arteries in the presence of cerebrovascular disease; chronic renal failure with creatinine clearance <30 ml / min; liver disease with an increase in AST and ALT levels of more than 3 times, compared to the upper limit of normal; history of muscular or neuromuscular diseases, with elevated CPK; alcoholism, oncological, mental and other severe concomitant diseases; intolerance to statins in anamnesis; use of other lipid-modifying agents.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:extended statin counseling group
Extended statins counseling.
Patients are handed out information leaflets on the correction of risk factors, SMS reminders.
|
Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.
|
介入なし:convetional statin counseling group
Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Assess the effect of routing and extended statin counseling on changes in treatment adherence
時間枠:Baseline and Month 12
|
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
|
Change from baseline in lipid levels (mmol/l)
時間枠:Baseline, Month 3, Month 6 and Month 12
|
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)
時間枠:Baseline, Month 3, Month 6 and Month 12
|
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
時間枠:Baseline and Month 12
|
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
|
協力者と研究者
捜査官
- スタディディレクター:Oxana M Drapkina, MD, PhD、Director of National Medical Research Center for Preventive Medicine, Moscow
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。