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A Prospective Observational P...

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

Last Updated: 2020-10-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-24

Study Completion Date

2019-07-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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History of Myocardial Infarction Hypertriglyceridemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Omacor (Omega-3-acid ethyl esters)

Adult patients with history of myocardial infarction not earlier than 6 months ago and/or with diagnosis of hypertriglyceridemia who having been prescribed Omacor for at least 6 months.

Omacor (Omega-3-acid ethyl esters)

Intervention Type DRUG

Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.

Interventions

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Omacor (Omega-3-acid ethyl esters)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women ≥ 18 years of age
* Patients with history of myocardial infarction not earlier than 6 months ago. AND/OR Patients with diagnosis of hypertriglyceridemia
* Patients having been prescribed Omacor (Omega-3 triglycerides \[EPA/DHA = 1.2/1 - 90%\]) for at least 6 months AND who have been taking Omacor no more than 14 days at the time of enrollment into the program.
* Patients who can, in the opinion of the Investigator, himself or through immediate relatives's help complete electronic system of data collection through mobile application or web-browser
* Patients who have signed the consent to participate in this program before entering their data in the electronic Case Report Form (eCRF) and who understand their right to discontinue the program at any time

Exclusion Criteria

* Patients taken medicines (except for Omacor) or nutrition supplements containing omega-3 in any proportions at the time of enrollment into the program OR it has been less than 3 months since last dose of medicines or nutrition supplements containing omega-3 taken.
* Female patients during pregnancy or breastfeeding
* Patients with increased sensitivity to the active substance, excipients, and soy
* Patients with exogenous hypertriglyceridemia (type I hyperchylomicronemia)
* Participation in any other clinical or non-clinical study/program at present or within the latest 30 days
* Patients with any other clinical states that make him/her ineligible for the program on the study doctor's opinion based on clinical assessment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers