Primary Prevention Program (3P)
9. september 2019 opdateret af: National Research Center for Preventive Medicine
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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2912
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Astrakhan, Den Russiske Føderation
- Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention
-
Nizhny Novgorod, Den Russiske Føderation
- Nizhny Novgorod Regional Center for Medical Prevention
-
Novosibirsk, Den Russiske Føderation
- Regional Center for Medical Prevention
-
Samara, Den Russiske Føderation
- Samara Regional Center for Medical Prevention
-
Ufa, Den Russiske Føderation
- Republican Center for Medical Prevention of the Republic of Bashkortostan
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: convetional statin counseling group
Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assess the effect of routing and extended statin counseling on changes in treatment adherence
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studieleder: Oxana M Drapkina, MD, PhD, Director of National Medical Research Center for Preventive Medicine, Moscow
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. juni 2018
Primær færdiggørelse (Faktiske)
28. august 2019
Studieafslutning (Faktiske)
28. august 2019
Datoer for studieregistrering
Først indsendt
12. februar 2019
Først indsendt, der opfyldte QC-kriterier
24. april 2019
Først opslået (Faktiske)
25. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 03-01/18
Plan for individuelle deltagerdata (IPD)
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