N/A
N=3,000
A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
History of Myocardial Infarction · Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT03415152 ↗Enrolled (actual)
3,000
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Mean Adherence Rate at the End of the Study (Visit 3) — 0.37 proportion of days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Omacor (Omega-3-acid ethyl esters) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Adherence Rate at the End of the Study (Visit 3) |
0.37 | — |
| SECONDARY Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3) |
12.9 | — |
| SECONDARY The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination |
0; 0.08; 0.43; 0.23; 1.94; 2.68 | — |
| SECONDARY 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) |
7.63; 32.86; 25.71; 20.81; 22.66; 26.43 | — |
| SECONDARY Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1) |
-1; -0.98; -0.77; 0.15; -1.32; -1.32 | — |
| SECONDARY Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program |
0.74; 99.26 | — |
| SECONDARY Number of New Cases of Stenocardia During 6 Months of the Program |
0.97; 99.03 | — |
| SECONDARY Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program |
0.04; 99.96 | — |
| SECONDARY Number of Cases of Cardio-vascular Death During 6 Months of the Program |
0.04 | — |
| SECONDARY Mean Adherence Rate at Visit 2 |
0.48 | — |
| SECONDARY Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2 |
0.24 | — |
| SECONDARY The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3 |
50; 15.56; 34.44; 75; 4.44; 20.56 | — |
| SECONDARY Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 2 |
12.55; 12.99 | — |
| SECONDARY 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) |
0.47; 0.44 | — |
Summary
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy
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
Data sourced from ClinicalTrials.gov (NCT03415152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.