Last updated on March 2019

A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy


Brief description of study

A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy

Detailed Study Description

It is known that only 50% of patients with chronic diseases adhere to medical recommendations; at the same time, high patient adherence significantly improve the survival of patients with chronic diseases. The treatment duration required to achieve a significant reduction in the risk of cardiovascular complications is the subject of discussion, but studies demonstrate that long-term therapy for 5 years or more gives the greatest effect. Today, during the era of technological progress, there is a possibility to freely apply information and telecommunication technologies (e.g. cell phones, computer) in different fields, including medicine. Remote monitoring of patients by means of phone calls using structured questionnaires can also significantly improve clinical outcomes (mortality and cardiovascular hospitalizations) by 38%. Unfortunately, in the case of a long-term, usually lifetime, treatment, the use of such methods is still very limited on a large scale.

This prospective observational program will help to explore the use of digital technologies and evaluate their effectiveness to increase patient adherence using an example of patients whose treatment scheme includes Omacor. Physicians and patients will be granted a personal access to the electronic data capture system. The physician will enter data about patients who signed the informed consent into the electronic system. At Visit 1 the patient will be given a card providing the personal access to his/her account in the electronic system. In addition to visits to the physician, the program specifies remote completion of the electronic form by the patient. Additional objective of the program includes raising patients' awareness about the disease due to familiarization with educational materials available in patient personal account in the electronic system.

This study is a prospective observational program within the frames of which Omacor (Omega-3 triglycerides [EPA/docosahexaenoic acid (DHA) = 1.2/1 - 90%]) is prescribed to patients with a history of myocardial infarction within a routine procedure as a part of the combination therapy (in combination with statins, antiaggregants, beta-blockers, angiotensin-converting enzyme inhibitors (ACE)) and/or to patients with hypertriglyceridemia. The population of observed patients will be limited to those who were prescribed Omacor for the first time or not earlier than 3 months after the last dose of Omacor and course of administration is at least 6 months. Discontinuation of the drug product administration by the patient is not the reason for exclusion of the patient from the study. For outcome measures which are applicable, further analysis will be performed in subgroups of patients with the different medication adherence rate: <0,5, 0,5-0,7, 0,8 at Visit 2 and Visit 3. Adherence rate will be calculated as the sum of days when patient taken the full prescribed dose of Omacor in period divided by the number of days in period.

Clinical Study Identifier: NCT03415152

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GBUZ Polyclinic of City Clinical Hospital 10

Khabarovsk, Russian Federation

GBUZ Regional clinical hospital 2

Krasnodar, Russian Federation

City polyclinic 22

Moscow, Russian Federation

OOO "Lechebnii center"

Moscow, Russian Federation

City polyclinic 195

Moscow, Russian Federation

Outpatient center of CDC #4

Moscow, Russian Federation

GBUZ City polyclinic # 43 DZM filial #3

Moscow, Russian Federation

Diagnostic Clinical Center 1

Moscow, Russian Federation

MC Sadko

Nizhny Novgorod, Russian Federation

MBUZ CRB Myasnitskogo region

Rostov-on-Don, Russian Federation

City polyclinic 2

Saratov, Russian Federation

OGBUZ Polyclinic 3

Smolensk, Russian Federation

GUZ Citi hospital 13

Tula, Russian Federation

Guz Gb 13

Tula, Russian Federation

TOKB KDC

Tula, Russian Federation

GBUZ RB Polyclinic 46

Ufa, Russian Federation

Recruitment Status: Closed


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