Influence of Additional Physician's Consultations and Short Message Service (SMS) Reminders to Patient Compliance (3P)

The Program to Assess the Influence of Routing and In-depth Consultation of Patients With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance

A systematic collection of retrospective and prospective data based on non-interventional 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 world medical practice.

Study Overview

• Status: Completed
• Conditions: Lipid Metabolism Disorders
• Intervention / Treatment: Drug: atorvastatin

Detailed Description

The research program will have two parts:

Stage 1: identification of patients with moderate, high and very high cardiovascular risk, 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.

• Study Type: Observational
• Enrollment (Actual): 2912

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119590
    • League of Clinical Research (LeagueCRR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The total population of patients (2912 people) will be divided into three strata:

patients with moderate risk of CVD (1242 patients) patients with high risk of CVD (1044 patients) patients with very high risk of CVD (626 patients). The subjects are randomized to a study or control group in each stratum in the ratio of 1: 1

Description

Inclusion criteria:

Data on the following subjects is planned to be collected in the project:

• Aged from 40 to 65 years inclusively
• With a high (≥5%) cardiovascular risk measured by SCORE and low density lipoprotein (LDL) levels of ≥2,5 mmol/L, or with a very high (≥10%) cardiovascular risk measured by SCORE and LDL levels ≥1,8 mmol/L or With atherosclerotic stenosis of brachiocephalic arteries of >50% in the absence of cerebrovascular disease

Exclusion criteria:

• No contraindications to statin treatment and not taking stating at study entry.

• History of the following clinically significant events and conditions:

  (а) myocardial infarction (б) stroke (в) transient ischemic attack

• Presence of the following diseases at the time of a statin administration:

  (а) ischemic heart disease (б) heart failure (в) peripheral artery atherosclerosis (г) atherosclerotic stenosis of brachiocephalic arteries with cerebrovascular disease .

Subjects must give their consent for processing of their personal data for the purposes of this scientific project.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Expanded consultation group; In an expanded consultation group is being conducted in the study group on the importance of primary prevention of cardiovascular diseases and on the reduction of cardiovascular risk by taking statins. Patients are given brochures and information materials on the risk factors for cardiovascular diseases and the possibility of their correction. Also, the patients of the study group are regularly reminded (2 times a month) with the help of SMS mailings and calls of health workers about the need to follow the doctor's recommendations for taking atorvastatin and returning to the medical institution.

Drug: atorvastatin; Profound patients' consultations (different from standard practice) on the importance of primary prevention of cardiovascular diseases, including preventive administration of statins. Subjects in profound consultation group will receive regular reminders (2 times a month) via SMS and phone calls to check following the doctor's recommendations and remind about follow-up visit to study centre.; Other Names: SMS and phone call reminders; Patients' consultations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target level of LDL cholesterol	To assess number of patients achieving the target level of low-density lipoprotein cholesterol in study group and in control group.	12 months

Collaborators and Investigators

• Sponsor: The League of Clinical Research, Russia
• Collaborators: National Research Center for Preventive Medicine
• Investigators: Study Director: Svetlana I Elkonina, MD, League of Clinical Research (LeagueCRR)

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: atorvastatin; prevention of cardiovascular diseases
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: Primary Prevention Program

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No