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

September 17, 2020 updated by: Abbott
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Astrakhan, Russian Federation, 414056
        • Gbuz Amokb Jsc
      • Bashkortostan, Russian Federation, 450071
        • polyclinic GKB №21
      • Bryansk, Russian Federation, 241050
        • GAUZ "BKDTs"
      • Chelyabinsk, Russian Federation, 454000
        • GP # 1
      • Chelyabinsk, Russian Federation, 454001
        • GKB №3
      • Kemerovo, Russian Federation, 650002
        • Federal State Budgetary Institution "Research Institute of Complex Problems of Cardiovascular Diseases"
      • Khabarovsk, Russian Federation, 680000
        • GBUZ Polyclinic of City Clinical Hospital № 10
      • Krasnodar, Russian Federation, 350000
        • GP #2
      • Krasnodar, Russian Federation, 350000
        • MBUZ GP number 11
      • Krasnodar, Russian Federation, 350012
        • Gbuz Kkb #2
      • Krasnodar, Russian Federation, 350012
        • GBUZ Regional clinical hospital № 2
      • Krasnodar, Russian Federation, 350049
        • Yablonovskaya polyclinic
      • Krasnodar, Russian Federation, 350059
        • KKB #1
      • Krasnodar, Russian Federation, 350061
        • City Polyclinic №27
      • Krasnodar, Russian Federation, 350061
        • GP №27
      • Krasnodar, Russian Federation, 350061
        • Llc "Auris"
      • Krasnodar, Russian Federation, 350063
        • City Polyclinic №7
      • Krasnodar, Russian Federation, 350075
        • Clinic Mamme
      • Krasnodar, Russian Federation, 350075
        • GP №15
      • Krasnodar, Russian Federation, 350080
        • GP №17
      • Krasnodar, Russian Federation, 350080
        • Mbuz Gp #17
      • Krasnodar, Russian Federation, 350086
        • Gbuz Nii Kkb №1
      • Krasnodar, Russian Federation, 350087
        • Gbuz "Nii-Kkb №1"
      • Krasnodar, Russian Federation, 350089
        • GP №25
      • Krasnodar, Russian Federation, 350910
        • MBUZ City Polyclinic #11
      • Krasnodar, Russian Federation, 350911
        • Municipal budgetary health institution "City Polyclinic # 11"
      • Krasnodar, Russian Federation, 350915
        • Mbuz Gkb №1
      • Krasnodar, Russian Federation, 350915
        • MC Ultramed
      • Krasnodar, Russian Federation, 353800
        • MUZ Polyclinic TsRB Poltava
      • Krasnodar, Russian Federation, 353925
        • Medical Center "Modern Cardiology"
      • Krasnodar, Russian Federation, 385141
        • Clinic "Medicine for All"
      • Krasnoyarsk, Russian Federation, 660021
        • Policlinic № 1
      • Maykop, Russian Federation, 385018
        • Maikop City Polyclinic №1
      • Moscow, Russian Federation, 115404
        • Polyclinic №52 branch №1
      • Moscow, Russian Federation, 115408
        • ГП № 210 branch 2
      • Moscow, Russian Federation, 115682
        • FGBU Federal Clinical Research Centre of Russia's Federal Medical-Biological Agency
      • Moscow, Russian Federation, 117218
        • Gbuz "Gp #22 Dzm"
      • Moscow, Russian Federation, 117292
        • Fsbi Enc Mz Rf
      • Moscow, Russian Federation, 117418
        • City polyclinic № 22
      • Moscow, Russian Federation, 117463
        • GP number 176
      • Moscow, Russian Federation, 117647
        • Diagnostic Clinical Center №1
      • Moscow, Russian Federation, 119034
        • OOO "Lechebnii center"
      • Moscow, Russian Federation, 121609
        • City polyclinic № 195
      • Moscow, Russian Federation, 121609
        • Outpatient center of CDC #4
      • Moscow, Russian Federation, 12517
        • GP №45
      • Moscow, Russian Federation, 125446
        • GBUZ City polyclinic # 43 DZM filial #3
      • Moscow, Russian Federation, 125466
        • GP №219 branch №4
      • Moscow, Russian Federation, 125480
        • Branch №1 DGP #94
      • Moscow, Russian Federation, 127410
        • MSU #169
      • Moscow, Russian Federation, 141021
        • Medical Center "Health"
      • Moscow, Russian Federation, 142400
        • Noginsk Central District Hospital
      • Moscow, Russian Federation, 142432
        • Hospital SCC RAS in Chernogolovka
      • Moscow, Russian Federation, 142432
        • Polyclinic of the National Science Center of the Russian Academy of Sciences in Chernogolovka
      • Nizhny Novgorod, Russian Federation, 600100
        • GBUZ NO Pavlovsk CRH
      • Nizhny Novgorod, Russian Federation, 603024
        • Llc "Healthy Little Healer"
      • Nizhny Novgorod, Russian Federation, 603074
        • MC "Sadko"
      • Nizhny Novgorod, Russian Federation, 603074
        • MC Sadko
      • Nizhny Novgorod, Russian Federation, 603076
        • MC Dobrii doctor
      • Nizhny Novgorod, Russian Federation, 603140
        • Cst on St.Nizhny Novgorod Oao Rzd
      • Nizhny Novgorod, Russian Federation, 603163
        • Polyclinic №7 branch 2
      • Nizhny Novgorod, Russian Federation, 606039
        • GP #2
      • Novosibirsk, Russian Federation, 630099
        • Gauz Nso Gkp #1
      • Omsk, Russian Federation, 644009
        • City polyclinic № 2
      • Omsk, Russian Federation, 644070
        • BUZOO "GP number 12"
      • Rostov, Russian Federation, 344000
        • Consultative clinic, Regional clinical hospital #2 Rostov region
      • Rostov, Russian Federation, 344000
        • GP №16
      • Rostov, Russian Federation, 34410
        • Polyclinic GB №7
      • Rostov, Russian Federation, 346880
        • NUZ Road Clinical Hospital at the station Rostov-Glavnii JSC "Russian Railways"
      • Rostov-on-Don, Russian Federation, 346803
        • MBUZ CRB Myasnitskogo region
      • Saint Petersburg, Russian Federation, 197022
        • Gbou Vpo Pspbgmu Im. I.P. Pavlova Ministry of Health of Russia
      • Saint Petersburg, Russian Federation, 197341
        • Fsbi "Szfmits Im. Va Almazova" Ministry of Health of Russia
      • Saint Petersburg, Russian Federation, 197372
        • GP №121
      • Samara, Russian Federation, 443041
        • Non-State Healthcare Institution "Road Clinical Hospital at Samara Station JSC "Russian Railways"
      • Samara, Russian Federation, 443065
        • Gbuz Sb Sgb #10
      • Samara, Russian Federation, 443074
        • GBUZ SO "Samara City Hospital 6"
      • Samara, Russian Federation, 443528
        • Gbuz Co "Volga Crh"
      • Samara, Russian Federation, 445040
        • Medical Center on Tupolev
      • Samara, Russian Federation, 445350
        • Zhigulevskaya polyclinic
      • Saratov, Russian Federation, 410005
        • City polyclinic № 2
      • Smolensk, Russian Federation, 214019
        • OGBUZ Polyclinic №3
      • Stavropol', Russian Federation, 355017
        • Gbuz Sk Skkkd
      • Stavropol', Russian Federation, 355026
        • Regional clinical cardiology dispensary
      • Stavropol', Russian Federation, 357538
        • GBUZ SK "Pyatigorsk GKB № 2"
      • Tatarstan, Russian Federation, 420101
        • Gaus Mkdts
      • Tula, Russian Federation, 300004
        • GUZ Citi hospital №13
      • Tula, Russian Federation, 300004
        • Guz Gb №13
      • Tula, Russian Federation, 300035
        • TOKB KDC
      • Tyumen, Russian Federation, 625048
        • First Cardiac Clinic
      • Ufa, Russian Federation, 450074
        • GBUZ RB Polyclinic № 46
      • Vladimir, Russian Federation, 600005
        • GBUZ IN city Polyclinic №1
      • Volgograd, Russian Federation, 400067
        • Guz "Polyclinic № 5"
      • Volgograd, Russian Federation, 400069
        • Volgograd Regional Clinical Cardiology Center
      • Voronezh, Russian Federation, 394051
        • BUZ IN "Voronezh city clinical polyclinic #7"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Omacor (Omega-3-acid ethyl esters)
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.

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)
Time Frame: 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.
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)
Time Frame: 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
6 months
The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
Time Frame: 6 months
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)
Time Frame: 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.
3 months, 6 months
Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
Time Frame: 3 months, 6 months

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
Time Frame: 6 months
Percentage of patients with hospitalizations due to cardiovascular disease
6 months
Number of New Cases of Stenocardia During 6 Months of the Program
Time Frame: 6 months
Percentage of patients with new cases of stenocardia
6 months
Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program
Time Frame: 6 months
Percentage of patients with non-fatal myocardial infarction cases
6 months
Number of Cases of Cardio-vascular Death During 6 Months of the Program
Time Frame: 6 months
Percentage of patients dead due to cardio-vascular death
6 months
Mean Adherence Rate at Visit 2
Time Frame: 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.
3 months
Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2
Time Frame: 3 months, 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.
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
Time Frame: 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
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
Time Frame: 0 months, 3 months

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)
Time Frame: Baseline, 3 Months, 6 Months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

January 30, 2018

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUFA5004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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