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

Study Overview
=================
Brief Summary
-----------------
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy

Detailed 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.

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

Conditions
-----------------
History of Myocardial Infarction, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: Omacor (Omega-3-acid ethyl esters)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omacor (Omega-3-acid ethyl esters)<br>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. | Drug: Omacor (Omega-3-acid ethyl esters)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Adherence Rate at the End of the Study (Visit 3) | Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3) | The average score for the National questionnaire on therapy compliance for all study duration Visit 1 - Visit 3. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance | 6 months | 
| The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | The percentage of patients (%) who have chosen each of the suggested reason for therapy termination. | 6 months | 
| The Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1) | Mean difference of the average score on each of 8 scales of Short Form Survey (SF)-36 quality of life questionnaire at Visit 2 and Visit 3 versus the baseline. 36-Item Short Form Survey (SF-36) taps eight health concepts. Each of 36 items is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state. | 3 months, 6 months | 
| Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1) | Mean difference of lipid profile parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1) | 3 months, 6 months | 
| Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program | Percentage of patients with hospitalizations due to cardiovascular disease | 6 months | 
| Number of New Cases of Stenocardia During 6 Months of the Program | Percentage of patients with new cases of stenocardia | 6 months | 
| Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program | Percentage of patients with non-fatal myocardial infarction cases | 6 months | 
| Number of Cases of Cardio-vascular Death During 6 Months of the Program | Percentage of patients dead due to cardio-vascular death | 6 months | 
| Mean Adherence Rate at Visit 2 | Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period. | 3 months | 
| Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2 | Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period. | 3 months, 6 months | 
| The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3 | The percentage of patients with adherence rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3 | 3 months, 6 months | 
| Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 2 | The average score for the National questionnaire on therapy compliance at Visit 1, Visit 2. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance | 0 months, 3 months | 
| Change of Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 2 and Visit 3 Versus Baseline (Visit 1) | The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance | Baseline, 3 Months, 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Omacor, Omega-3-acid ethyl esters, patient adherence, patient reported outcomes