A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
DIAPAsOn
1 other identifier
observational
3,000
1 country
93
Brief Summary
A prospective observational program using digital technology tools to enhance patient adherence to Omacor therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2018
CompletedStudy Start
First participant enrolled
January 24, 2018
CompletedFirst Posted
Study publicly available on registry
January 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedResults Posted
Study results publicly available
October 12, 2020
CompletedOctober 12, 2020
September 1, 2020
1.4 years
January 3, 2018
June 25, 2020
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
6 months
Secondary Outcomes (13)
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 Percentage of Patients Who Have Chosen Each of the Suggested Reasons 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)
3 months, 6 months
Change 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
6 months
- +8 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (93)
Gbuz Amokb Jsc
Astrakhan, 414056, Russia
polyclinic GKB №21
Bashkortostan, 450071, Russia
GAUZ "BKDTs"
Bryansk, 241050, Russia
GP # 1
Chelyabinsk, 454000, Russia
GKB №3
Chelyabinsk, 454001, Russia
Federal State Budgetary Institution "Research Institute of Complex Problems of Cardiovascular Diseases"
Kemerovo, 650002, Russia
GBUZ Polyclinic of City Clinical Hospital № 10
Khabarovsk, 680000, Russia
GP #2
Krasnodar, 350000, Russia
MBUZ GP number 11
Krasnodar, 350000, Russia
Gbuz Kkb #2
Krasnodar, 350012, Russia
GBUZ Regional clinical hospital № 2
Krasnodar, 350012, Russia
Yablonovskaya polyclinic
Krasnodar, 350049, Russia
KKB #1
Krasnodar, 350059, Russia
City Polyclinic №27
Krasnodar, 350061, Russia
GP №27
Krasnodar, 350061, Russia
Llc "Auris"
Krasnodar, 350061, Russia
City Polyclinic №7
Krasnodar, 350063, Russia
Clinic Mamme
Krasnodar, 350075, Russia
GP №15
Krasnodar, 350075, Russia
GP №17
Krasnodar, 350080, Russia
Mbuz Gp #17
Krasnodar, 350080, Russia
Gbuz Nii Kkb №1
Krasnodar, 350086, Russia
Gbuz "Nii-Kkb №1"
Krasnodar, 350087, Russia
GP №25
Krasnodar, 350089, Russia
MBUZ City Polyclinic #11
Krasnodar, 350910, Russia
Municipal budgetary health institution "City Polyclinic # 11"
Krasnodar, 350911, Russia
Mbuz Gkb №1
Krasnodar, 350915, Russia
MC Ultramed
Krasnodar, 350915, Russia
MUZ Polyclinic TsRB Poltava
Krasnodar, 353800, Russia
Medical Center "Modern Cardiology"
Krasnodar, 353925, Russia
Clinic "Medicine for All"
Krasnodar, 385141, Russia
Policlinic № 1
Krasnoyarsk, 660021, Russia
Maikop City Polyclinic №1
Maykop, 385018, Russia
Polyclinic №52 branch №1
Moscow, 115404, Russia
ГП № 210 branch 2
Moscow, 115408, Russia
FGBU Federal Clinical Research Centre of Russia's Federal Medical-Biological Agency
Moscow, 115682, Russia
Gbuz "Gp #22 Dzm"
Moscow, 117218, Russia
Fsbi Enc Mz Rf
Moscow, 117292, Russia
City polyclinic № 22
Moscow, 117418, Russia
GP number 176
Moscow, 117463, Russia
Diagnostic Clinical Center №1
Moscow, 117647, Russia
OOO "Lechebnii center"
Moscow, 119034, Russia
City polyclinic № 195
Moscow, 121609, Russia
Outpatient center of CDC #4
Moscow, 121609, Russia
GP №45
Moscow, 12517, Russia
GBUZ City polyclinic # 43 DZM filial #3
Moscow, 125446, Russia
GP №219 branch №4
Moscow, 125466, Russia
Branch №1 DGP #94
Moscow, 125480, Russia
MSU #169
Moscow, 127410, Russia
Medical Center "Health"
Moscow, 141021, Russia
Noginsk Central District Hospital
Moscow, 142400, Russia
Hospital SCC RAS in Chernogolovka
Moscow, 142432, Russia
Polyclinic of the National Science Center of the Russian Academy of Sciences in Chernogolovka
Moscow, 142432, Russia
GBUZ NO Pavlovsk CRH
Nizhny Novgorod, 600100, Russia
Llc "Healthy Little Healer"
Nizhny Novgorod, 603024, Russia
MC "Sadko"
Nizhny Novgorod, 603074, Russia
MC Sadko
Nizhny Novgorod, 603074, Russia
MC Dobrii doctor
Nizhny Novgorod, 603076, Russia
Cst on St.Nizhny Novgorod Oao Rzd
Nizhny Novgorod, 603140, Russia
Polyclinic №7 branch 2
Nizhny Novgorod, 603163, Russia
GP #2
Nizhny Novgorod, 606039, Russia
Gauz Nso Gkp #1
Novosibirsk, 630099, Russia
City Polyclinic № 2
Omsk, 644009, Russia
BUZOO "GP number 12"
Omsk, 644070, Russia
Consultative clinic, Regional clinical hospital #2 Rostov region
Rostov, 344000, Russia
GP №16
Rostov, 344000, Russia
Polyclinic GB №7
Rostov, 34410, Russia
NUZ Road Clinical Hospital at the station Rostov-Glavnii JSC "Russian Railways"
Rostov, 346880, Russia
MBUZ CRB Myasnitskogo region
Rostov-on-Don, 346803, Russia
Gbou Vpo Pspbgmu Im. I.P. Pavlova Ministry of Health of Russia
Saint Petersburg, 197022, Russia
Fsbi "Szfmits Im. Va Almazova" Ministry of Health of Russia
Saint Petersburg, 197341, Russia
GP №121
Saint Petersburg, 197372, Russia
Non-State Healthcare Institution "Road Clinical Hospital at Samara Station JSC "Russian Railways"
Samara, 443041, Russia
Gbuz Sb Sgb #10
Samara, 443065, Russia
GBUZ SO "Samara City Hospital 6"
Samara, 443074, Russia
Gbuz Co "Volga Crh"
Samara, 443528, Russia
Medical Center on Tupolev
Samara, 445040, Russia
Zhigulevskaya polyclinic
Samara, 445350, Russia
City polyclinic № 2
Saratov, 410005, Russia
OGBUZ Polyclinic №3
Smolensk, 214019, Russia
Gbuz Sk Skkkd
Stavropol, 355017, Russia
Regional Clinical Cardiology Dispensary
Stavropol, 355026, Russia
GBUZ SK "Pyatigorsk GKB № 2"
Stavropol, 357538, Russia
Gaus Mkdts
Tatarstan, 420101, Russia
GUZ Citi hospital №13
Tula, 300004, Russia
Guz Gb №13
Tula, 300004, Russia
TOKB KDC
Tula, 300035, Russia
First Cardiac Clinic
Tyumen, 625048, Russia
GBUZ RB Polyclinic № 46
Ufa, 450074, Russia
GBUZ IN city Polyclinic №1
Vladimir, 600005, Russia
Guz "Polyclinic № 5"
Volgograd, 400067, Russia
Volgograd Regional Clinical Cardiology Center
Volgograd, 400069, Russia
BUZ IN "Voronezh city clinical polyclinic #7"
Voronezh, 394051, Russia
Related Publications (1)
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.
PMID: 35877173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
Results Point of Contact
- Title
- Irina Solnyshkina
- Organization
- Abbott Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2018
First Posted
January 30, 2018
Study Start
January 24, 2018
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
October 12, 2020
Results First Posted
October 12, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share