Trial · NCT03415152
A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
NCT03415152, Completed, Abbott; results first posted 2020-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy. Trials, record NCT03415152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03415152
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
- NCT number
- NCT03415152
- Status
- Completed
- Enrollment
- 3,000 participants, actual
- Lead sponsor
- Abbott
- Conditions
- History of Myocardial Infarction, Hypertriglyceridemia
- Interventions
- Omacor (Omega-3-acid ethyl esters)
- First posted
- 2018-01-30
- Last updated
- 2020-10-12
- Results first posted
- 2020-10-12
- Limitations and caveats
Score on the G. Health of the SF-36 scale should not be taken into account due to a technical error occurred at the stage of transferring the scale to the electronic case report form and which affected the results, changing the patient's responses
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Adherence Rate at the End of the Study (Visit 3) | 6 months | 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. |
| Secondary | Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3) | 6 months | 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 |
| Secondary | The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | 6 months | The percentage of patients (%) who have chosen each of the suggested reason for therapy termination. |
| 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) | 3 months, 6 months | 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. |
| Secondary | Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1) | 3 months, 6 months | Mean difference of lipid profile parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1\) |
| Secondary | Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program | 6 months | Percentage of patients with hospitalizations due to cardiovascular disease |
| Secondary | Number of New Cases of Stenocardia During 6 Months of the Program | 6 months | Percentage of patients with new cases of stenocardia |
| Secondary | Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program | 6 months | Percentage of patients with non-fatal myocardial infarction cases |
| Secondary | Number of Cases of Cardio-vascular Death During 6 Months of the Program | 6 months | Percentage of patients dead due to cardio-vascular death |
| Secondary | Mean Adherence Rate at Visit 2 | 3 months | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Adherence Rate at the End of the Study (Visit 3) | 6 months | Population of patients registered in electronic system and reported Omacor administration | proportion of days | MEAN |
| SECONDARY | Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3) | 6 months | Population of patients attended at Visit 3 (month 6) | score on a scale | MEAN |
| SECONDARY | The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | 6 months | percentage of participants | NUMBER | |
| 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) | 3 months, 6 months | Population of patients registered in electronic system and reported Omacor administration | score on a scale | MEAN |
| SECONDARY | Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1) | 3 months, 6 months | Per protocol population: patients who attended at least one follow-up visit. | mmol/L | MEAN |
| SECONDARY | Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Number of New Cases of Stenocardia During 6 Months of the Program | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Cases of Cardio-vascular Death During 6 Months of the Program | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Mean Adherence Rate at Visit 2 | 3 months | Population of patients registered in electronic system and reported Omacor administration | proportion of days | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Adherence Rate at the End of the Study (Visit 3) | Omacor (Omega-3-acid Ethyl Esters) | 0.37 | Standard Deviation 0.38 | proportion of days | |
| Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3) | Omacor (Omega-3-acid Ethyl Esters) | 12.9 | Standard Deviation 2.99 | score on a scale | |
| The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | Omacor (Omega-3-acid Ethyl Esters) | Adverse drug reactions | 0 | percentage of participants | |
| The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | Omacor (Omega-3-acid Ethyl Esters) | Lack of efficacy | 0.08 | percentage of participants | |
| The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | Omacor (Omega-3-acid Ethyl Esters) | Inconvenience of use | 0.43 | percentage of participants | |
| The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | Omacor (Omega-3-acid Ethyl Esters) | Absence at the pharmacy | 0.23 | percentage of participants | |
| The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | Omacor (Omega-3-acid Ethyl Esters) | Other reason | 1.94 | percentage of participants | |
| The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | Omacor (Omega-3-acid Ethyl Esters) | Total | 2.68 | percentage of participants | |
| 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) | Omacor (Omega-3-acid Ethyl Esters) | Physical functioning (V2-V1,3 m) | 7.63 | Standard Deviation 13.4 | score on a scale |
| 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) | Omacor (Omega-3-acid Ethyl Esters) | Role limitations due to physical health (V2-V1,3m) | 32.86 | Standard Deviation 48.42 | score on a scale |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omacor (Omega-3-acid Ethyl Esters) | 3,000 | |
| Overall Study | COMPLETED | Omacor (Omega-3-acid Ethyl Esters) | 1,975 | |
| Overall Study | NOT COMPLETED | Omacor (Omega-3-acid Ethyl Esters) | 1,025 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eructation | Gastrointestinal disorders | Omacor (Omega-3-acid Ethyl Esters) | 1 | 3,000 | 1 |
| other | Abnormal faeces | Gastrointestinal disorders | Omacor (Omega-3-acid Ethyl Esters) | 1 | 3,000 | 1 |
| other | Nausea | Gastrointestinal disorders | Omacor (Omega-3-acid Ethyl Esters) | 1 | 3,000 | 1 |
| other | Alanine aminotransferase increased | Investigations | Omacor (Omega-3-acid Ethyl Esters) | 1 | 3,000 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omacor (Omega-3-acid Ethyl Esters) | 4 | 3,000 |
| Total, other adverse events | Omacor (Omega-3-acid Ethyl Esters) | 4 | 3,000 |
| Total, serious adverse events | Omacor (Omega-3-acid Ethyl Esters) | 0 | 3,000 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35877173 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03415152
GET https://conductscience.org/api/trials/v1/NCT03415152/results?page=2