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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 15, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The League of Clinical Research, Russia
  • Collaborator
    • National Research Center for Preventive Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Svetlana I Elkonina, MD, Study Director, League of Clinical Research (LeagueCRR)

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