Clinical trial NCT03415152: A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
Official title: A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: History of Myocardial Infarction
Hypertriglyceridemia
Keywords: Omacor
Omega-3-acid ethyl esters
patient adherence
patient reported outcomes
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

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

Primary outcomes:
measure: Mean Adherence Rate at the End of the Study (Visit 3)
timeFrame: 6 months
Secondary outcomes:
measure: Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3)
timeFrame: 6 months
measure: The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination
timeFrame: 6 months
measure: 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)
timeFrame: 3 months, 6 months
measure: Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)
timeFrame: 3 months, 6 months
measure: Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program
timeFrame: 6 months
measure: Number of New Cases of Stenocardia During 6 Months of the Program
timeFrame: 6 months
measure: Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program
timeFrame: 6 months
measure: Number of Cases of Cardio-vascular Death During 6 Months of the Program
timeFrame: 6 months
measure: Mean Adherence Rate at Visit 2
timeFrame: 3 months
measure: Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2
timeFrame: 3 months, 6 months
measure: The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3
timeFrame: 3 months, 6 months
measure: Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 2
timeFrame: 0 months, 3 months
measure: 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)
timeFrame: Baseline, 3 Months, 6 Months
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Gbuz Amokb Jsc
city: Bashkortostan
country: Russian Federation
facility: polyclinic GKB №21
city: Bryansk
country: Russian Federation
facility: GAUZ "BKDTs"
city: Chelyabinsk
country: Russian Federation
facility: GP # 1
city: Chelyabinsk
country: Russian Federation
facility: GKB №3
city: Kemerovo
country: Russian Federation
facility: Federal State Budgetary Institution "Research Institute of Complex Problems of Cardiovascular Diseases"
city: Khabarovsk
country: Russian Federation
facility: GBUZ Polyclinic of City Clinical Hospital № 10
city: Krasnodar
country: Russian Federation
facility: GP #2
city: Krasnodar
country: Russian Federation
facility: MBUZ GP number 11
city: Krasnodar
country: Russian Federation
facility: Gbuz Kkb #2
city: Krasnodar
country: Russian Federation
facility: GBUZ Regional clinical hospital № 2
city: Krasnodar
country: Russian Federation
facility: Yablonovskaya polyclinic
city: Krasnodar
country: Russian Federation
facility: KKB #1
city: Krasnodar
country: Russian Federation
facility: City Polyclinic №27
city: Krasnodar
country: Russian Federation
facility: GP №27
city: Krasnodar
country: Russian Federation
facility: Llc "Auris"
city: Krasnodar
country: Russian Federation
facility: City Polyclinic №7
city: Krasnodar
country: Russian Federation
facility: Clinic Mamme
city: Krasnodar
country: Russian Federation
facility: GP №15
city: Krasnodar
country: Russian Federation
facility: GP №17
city: Krasnodar
country: Russian Federation
facility: Mbuz Gp #17
city: Krasnodar
country: Russian Federation
facility: Gbuz Nii Kkb №1
city: Krasnodar
country: Russian Federation
facility: Gbuz "Nii-Kkb №1"
city: Krasnodar
country: Russian Federation
facility: GP №25
city: Krasnodar
country: Russian Federation
facility: MBUZ City Polyclinic #11
city: Krasnodar
country: Russian Federation
facility: Municipal budgetary health institution "City Polyclinic # 11"
city: Krasnodar
country: Russian Federation
facility: Mbuz Gkb №1
city: Krasnodar
country: Russian Federation
facility: MC Ultramed
city: Krasnodar
country: Russian Federation
facility: MUZ Polyclinic TsRB Poltava
city: Krasnodar
country: Russian Federation
facility: Medical Center "Modern Cardiology"
city: Krasnodar
country: Russian Federation
facility: Clinic "Medicine for All"
city: Krasnoyarsk
country: Russian Federation
facility: Policlinic № 1
city: Maykop
country: Russian Federation
facility: Maikop City Polyclinic №1
city: Moscow
country: Russian Federation
facility: Polyclinic №52 branch №1
city: Moscow
country: Russian Federation
facility: ГП № 210 branch 2
city: Moscow
country: Russian Federation
facility: FGBU Federal Clinical Research Centre of Russia's Federal Medical-Biological Agency
city: Moscow
country: Russian Federation
facility: Gbuz "Gp #22 Dzm"
city: Moscow
country: Russian Federation
facility: Fsbi Enc Mz Rf
city: Moscow
country: Russian Federation
facility: City polyclinic № 22
city: Moscow
country: Russian Federation
facility: GP number 176
city: Moscow
country: Russian Federation
facility: Diagnostic Clinical Center №1
city: Moscow
country: Russian Federation
facility: OOO "Lechebnii center"
city: Moscow
country: Russian Federation
facility: City polyclinic № 195
city: Moscow
country: Russian Federation
facility: Outpatient center of CDC #4
city: Moscow
country: Russian Federation
facility: GP №45
city: Moscow
country: Russian Federation
facility: GBUZ City polyclinic # 43 DZM filial #3
city: Moscow
country: Russian Federation
facility: GP №219 branch №4
city: Moscow
country: Russian Federation
facility: Branch №1 DGP #94
city: Moscow
country: Russian Federation
facility: MSU #169
city: Moscow
country: Russian Federation
facility: Medical Center "Health"
city: Moscow
country: Russian Federation
facility: Noginsk Central District Hospital
city: Moscow
country: Russian Federation
facility: Hospital SCC RAS in Chernogolovka
city: Moscow
country: Russian Federation
facility: Polyclinic of the National Science Center of the Russian Academy of Sciences in Chernogolovka
city: Nizhny Novgorod
country: Russian Federation
facility: GBUZ NO Pavlovsk CRH
city: Nizhny Novgorod
country: Russian Federation
facility: Llc "Healthy Little Healer"
city: Nizhny Novgorod
country: Russian Federation
facility: MC "Sadko"
city: Nizhny Novgorod
country: Russian Federation
facility: MC Sadko
city: Nizhny Novgorod
country: Russian Federation
facility: MC Dobrii doctor
city: Nizhny Novgorod
country: Russian Federation
facility: Cst on St.Nizhny Novgorod Oao Rzd
city: Nizhny Novgorod
country: Russian Federation
facility: Polyclinic №7 branch 2
city: Nizhny Novgorod
country: Russian Federation
facility: GP #2
city: Novosibirsk
country: Russian Federation
facility: Gauz Nso Gkp #1
city: Omsk
country: Russian Federation
facility: City Polyclinic № 2
city: Omsk
country: Russian Federation
facility: BUZOO "GP number 12"
city: Rostov-on-Don
country: Russian Federation
facility: MBUZ CRB Myasnitskogo region
city: Rostov
country: Russian Federation
facility: Consultative clinic, Regional clinical hospital #2 Rostov region
city: Rostov
country: Russian Federation
facility: GP №16
city: Rostov
country: Russian Federation
facility: Polyclinic GB №7
city: Rostov
country: Russian Federation
facility: NUZ Road Clinical Hospital at the station Rostov-Glavnii JSC "Russian Railways"
city: Saint Petersburg
country: Russian Federation
facility: Gbou Vpo Pspbgmu Im. I.P. Pavlova Ministry of Health of Russia
city: Saint Petersburg
country: Russian Federation
facility: Fsbi "Szfmits Im. Va Almazova" Ministry of Health of Russia
city: Saint Petersburg
country: Russian Federation
facility: GP №121
city: Samara
country: Russian Federation
facility: Non-State Healthcare Institution "Road Clinical Hospital at Samara Station JSC "Russian Railways"
city: Samara
country: Russian Federation
facility: Gbuz Sb Sgb #10
city: Samara
country: Russian Federation
facility: GBUZ SO "Samara City Hospital 6"
city: Samara
country: Russian Federation
facility: Gbuz Co "Volga Crh"
city: Samara
country: Russian Federation
facility: Medical Center on Tupolev
city: Samara
country: Russian Federation
facility: Zhigulevskaya polyclinic
city: Saratov
country: Russian Federation
facility: City polyclinic № 2
city: Smolensk
country: Russian Federation
facility: OGBUZ Polyclinic №3
city: Stavropol'
country: Russian Federation
facility: Gbuz Sk Skkkd
city: Stavropol'
country: Russian Federation
facility: Regional Clinical Cardiology Dispensary
city: Stavropol'
country: Russian Federation
facility: GBUZ SK "Pyatigorsk GKB № 2"
city: Tatarstan
country: Russian Federation
facility: Gaus Mkdts
city: Tula
country: Russian Federation
facility: GUZ Citi hospital №13
city: Tula
country: Russian Federation
facility: Guz Gb №13
city: Tula
country: Russian Federation
facility: TOKB KDC
city: Tyumen
country: Russian Federation
facility: First Cardiac Clinic
city: Ufa
country: Russian Federation
facility: GBUZ RB Polyclinic № 46
city: Vladimir
country: Russian Federation
facility: GBUZ IN city Polyclinic №1
city: Volgograd
country: Russian Federation
facility: Guz "Polyclinic № 5"
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Cardiology Center
city: Voronezh
country: Russian Federation
facility: BUZ IN "Voronezh city clinical polyclinic #7"
Study officials:
References:
citation: 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.