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

Completed

• Conditions: Lipid Metabolism Disorders
• Interventions: Drug: atorvastatin

• Registration Number: NCT04863274
• Lead Sponsor: The League of Clinical Research, Russia

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.

Study Timeline

• Study Start: 2018-06-21
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Study First Submitted: 2021-01-20
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-28
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2912

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Expanded consultation group	atorvastatin	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

League of Clinical Research (LeagueCRR); 🇷🇺 Moscow, Russian Federation