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

NCT04863274 | Completed FDA Drug

• 1 other identifier: Primary Prevention Program
• Study Type: observational
• Target: 2,912
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lipid Metabolism Disorders

Keywords

prevention of cardiovascular diseases; atorvastatin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

atorvastatin DRUG

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.

Also known as: SMS and phone call reminders, Patients' consultations

Expanded consultation group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The League of Clinical Research, Russia: lead
• National Research Center for Preventive Medicine: collaborator

Study Sites (1)

League of Clinical Research (LeagueCRR)

Moscow, 119590, Russia

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Interventions

Atorvastatin; Spermine Synthase

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Svetlana I Elkonina, MD

  League of Clinical Research (LeagueCRR)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: April 28, 2021
• Study Start: June 21, 2018
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)