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History of Myocardial InfarctionDIAPAsOnNCT03415152

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

An observational study of History of Myocardial Infarction and Hypertriglyceridemia, run by Abbott at 93 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Omacor (Omega-3-acid ethyl esters)
How many people
3,000 participants
Where
93 sitesRussia
Study dates
24 Jan 2018to 1 Jul 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients with myocardial infarction in anamnesis and/or diagnosis of hypertriglyceridemia who are under medical supervision in healthcare institutions of Russia and receive Omacor

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

93 sites in 1 country.

93 sites in 1 country

Russia93 sites

  • Gbuz Amokb Jsc

    Astrakhan, 414056

  • polyclinic GKB №21

    Bashkortostan, 450071

  • GAUZ "BKDTs"

    Bryansk, 241050

  • GP # 1

    Chelyabinsk, 454000

  • GKB №3

    Chelyabinsk, 454001

  • Federal State Budgetary Institution "Research Institute of Complex Problems of Cardiovascular Diseases"

    Kemerovo, 650002

  • GBUZ Polyclinic of City Clinical Hospital № 10

    Khabarovsk, 680000

  • GP #2

    Krasnodar, 350000

  • MBUZ GP number 11

    Krasnodar, 350000

  • Gbuz Kkb #2

    Krasnodar, 350012

  • GBUZ Regional clinical hospital № 2

    Krasnodar, 350012

  • Yablonovskaya polyclinic

    Krasnodar, 350049

  • KKB #1

    Krasnodar, 350059

  • City Polyclinic №27

    Krasnodar, 350061

  • GP №27

    Krasnodar, 350061

  • Llc "Auris"

    Krasnodar, 350061

  • City Polyclinic №7

    Krasnodar, 350063

  • Clinic Mamme

    Krasnodar, 350075

  • GP №15

    Krasnodar, 350075

  • GP №17

    Krasnodar, 350080

  • Mbuz Gp #17

    Krasnodar, 350080

  • Gbuz Nii Kkb №1

    Krasnodar, 350086

  • Gbuz "Nii-Kkb №1"

    Krasnodar, 350087

  • GP №25

    Krasnodar, 350089

  • MBUZ City Polyclinic #11

    Krasnodar, 350910

  • Municipal budgetary health institution "City Polyclinic # 11"

    Krasnodar, 350911

  • Mbuz Gkb №1

    Krasnodar, 350915

  • MC Ultramed

    Krasnodar, 350915

  • MUZ Polyclinic TsRB Poltava

    Krasnodar, 353800

  • Medical Center "Modern Cardiology"

    Krasnodar, 353925

  • Clinic "Medicine for All"

    Krasnodar, 385141

  • Policlinic № 1

    Krasnoyarsk, 660021

  • Maikop City Polyclinic №1

    Maykop, 385018

  • Polyclinic №52 branch №1

    Moscow, 115404

  • ГП № 210 branch 2

    Moscow, 115408

  • FGBU Federal Clinical Research Centre of Russia's Federal Medical-Biological Agency

    Moscow, 115682

  • Gbuz "Gp #22 Dzm"

    Moscow, 117218

  • Fsbi Enc Mz Rf

    Moscow, 117292

  • City polyclinic № 22

    Moscow, 117418

  • GP number 176

    Moscow, 117463

  • Diagnostic Clinical Center №1

    Moscow, 117647

  • OOO "Lechebnii center"

    Moscow, 119034

  • City polyclinic № 195

    Moscow, 121609

  • Outpatient center of CDC #4

    Moscow, 121609

  • GP №45

    Moscow, 12517

  • GBUZ City polyclinic # 43 DZM filial #3

    Moscow, 125446

  • GP №219 branch №4

    Moscow, 125466

  • Branch №1 DGP #94

    Moscow, 125480

  • MSU #169

    Moscow, 127410

  • Medical Center "Health"

    Moscow, 141021

  • Noginsk Central District Hospital

    Moscow, 142400

  • Hospital SCC RAS in Chernogolovka

    Moscow, 142432

  • Polyclinic of the National Science Center of the Russian Academy of Sciences in Chernogolovka

    Moscow, 142432

  • GBUZ NO Pavlovsk CRH

    Nizhny Novgorod, 600100

  • Llc "Healthy Little Healer"

    Nizhny Novgorod, 603024

  • MC "Sadko"

    Nizhny Novgorod, 603074

  • MC Sadko

    Nizhny Novgorod, 603074

  • MC Dobrii doctor

    Nizhny Novgorod, 603076

  • Cst on St.Nizhny Novgorod Oao Rzd

    Nizhny Novgorod, 603140

  • Polyclinic №7 branch 2

    Nizhny Novgorod, 603163

  • GP #2

    Nizhny Novgorod, 606039

  • Gauz Nso Gkp #1

    Novosibirsk, 630099

  • City Polyclinic № 2

    Omsk, 644009

  • BUZOO "GP number 12"

    Omsk, 644070

  • Consultative clinic, Regional clinical hospital #2 Rostov region

    Rostov-on-Don, 344000

  • GP №16

    Rostov-on-Don, 344000

  • Polyclinic GB №7

    Rostov-on-Don, 34410

  • MBUZ CRB Myasnitskogo region

    Rostov-on-Don, 346803

  • NUZ Road Clinical Hospital at the station Rostov-Glavnii JSC "Russian Railways"

    Rostov-on-Don, 346880

  • Gbou Vpo Pspbgmu Im. I.P. Pavlova Ministry of Health of Russia

    Saint Petersburg, 197022

  • Fsbi "Szfmits Im. Va Almazova" Ministry of Health of Russia

    Saint Petersburg, 197341

  • GP №121

    Saint Petersburg, 197372

  • Non-State Healthcare Institution "Road Clinical Hospital at Samara Station JSC "Russian Railways"

    Samara, 443041

  • Gbuz Sb Sgb #10

    Samara, 443065

  • GBUZ SO "Samara City Hospital 6"

    Samara, 443074

  • Gbuz Co "Volga Crh"

    Samara, 443528

  • Medical Center on Tupolev

    Samara, 445040

  • Zhigulevskaya polyclinic

    Samara, 445350

  • City polyclinic № 2

    Saratov, 410005

  • OGBUZ Polyclinic №3

    Smolensk, 214019

  • Gbuz Sk Skkkd

    Stavropol, 355017

  • Regional Clinical Cardiology Dispensary

    Stavropol, 355026

  • GBUZ SK "Pyatigorsk GKB № 2"

    Stavropol, 357538

  • Gaus Mkdts

    Tatarstan, 420101

  • GUZ Citi hospital №13

    Tula, 300004

  • Guz Gb №13

    Tula, 300004

  • TOKB KDC

    Tula, 300035

  • First Cardiac Clinic

    Tyumen, 625048

  • GBUZ RB Polyclinic № 46

    Ufa, 450074

  • GBUZ IN city Polyclinic №1

    Vladimir, 600005

  • Guz "Polyclinic № 5"

    Volgograd, 400067

  • Volgograd Regional Clinical Cardiology Center

    Volgograd, 400069

  • BUZ IN "Voronezh city clinical polyclinic #7"

    Voronezh, 394051

Other trials in Russia

About this study

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

Read the 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.

Being tested
Omacor (Omega-3-acid ethyl esters)
Keywords
Omacor, Omega-3-acid ethyl esters, patient adherence, patient reported outcomes
Medical subject headings
Hypertriglyceridemia, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omacor (Omega-3-acid ethyl esters)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.

Study groups in NCT03415152
Study groupRoleWhat they receive
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.
Receives: Drug: Omacor (Omega-3-acid ethyl esters)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (13)

  1. 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

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 3 months, 6 months

  4. 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)

    Measured: 3 months, 6 months

  5. Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program

    Percentage of patients with hospitalizations due to cardiovascular disease

    Measured: 6 months

  6. Number of New Cases of Stenocardia During 6 Months of the Program

    Percentage of patients with new cases of stenocardia

    Measured: 6 months

  7. Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program

    Percentage of patients with non-fatal myocardial infarction cases

    Measured: 6 months

  8. Number of Cases of Cardio-vascular Death During 6 Months of the Program

    Percentage of patients dead due to cardio-vascular death

    Measured: 6 months

  9. 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.

    Measured: 3 months

  10. 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.

    Measured: 3 months, 6 months

  11. 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

    Measured: 3 months, 6 months

  12. 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

    Measured: 0 months, 3 months

  13. 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

    Measured: Baseline, 3 Months, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start24 Jan 2018
  3. Primary completion1 Jul 2019
  4. Study completion1 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03415152
Sponsor's protocol ID
PUFA5004
Acronym
DIAPAsOn
Status last verified
Sep 2020
First submitted
3 Jan 2018
Last updated
12 Oct 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arutyunov GP, Arutyunov AG, Ageev FT, Fofanova TV. Use of Digital Technology Tools to Characterize Adherence to Prescription-Grade Omega-3 Polyunsaturated Fatty Acid Therapy in Postmyocardial or Hypertriglyceridemic Patients in the DIAPAsOn Study: Prospective Observational Study. JMIR Cardio. 2022 Jul 25;6(2):e37490. doi: 10.2196/37490.

    PubMed 35877173

Questions about this trial

What is this clinical trial studying?

An observational study of History of Myocardial Infarction and Hypertriglyceridemia, run by Abbott at 93 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Adherence Rate at the End of the Study (Visit 3) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03415152, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.

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