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

NCT ID: NCT04863274

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2912 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2020-10-15

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.

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.

Conditions

Lipid Metabolism Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

atorvastatin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

SMS and phone call reminders; Patients' consultations

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role: collaborator

The League of Clinical Research, Russia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svetlana I Elkonina, MD

Role: STUDY_DIRECTOR

League of Clinical Research (LeagueCRR)

Locations

League of Clinical Research (LeagueCRR)

Moscow, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Primary Prevention Program

Identifier Type: -

Identifier Source: org_study_id