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

Hypertriglyceridemia Clinical Trial

— DIAPAsOn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415152
• Other study ID #: PUFA5004
• Status: Completed
• Start date: January 24, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2020
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• History of Myocardial Infarction
• Hypertriglyceridemia
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Gbuz Amokb Jsc	Astrakhan
Russian Federation	polyclinic GKB ?21	Bashkortostan
Russian Federation	GAUZ "BKDTs"	Bryansk
Russian Federation	GKB ?3	Chelyabinsk
Russian Federation	GP # 1	Chelyabinsk
Russian Federation	Federal State Budgetary Institution "Research Institute of Complex Problems of Cardiovascular Diseases"	Kemerovo
Russian Federation	GBUZ Polyclinic of City Clinical Hospital ? 10	Khabarovsk
Russian Federation	City Polyclinic ?27	Krasnodar
Russian Federation	City Polyclinic ?7	Krasnodar
Russian Federation	Clinic "Medicine for All"	Krasnodar
Russian Federation	Clinic Mamme	Krasnodar
Russian Federation	Gbuz "Nii-Kkb ?1"	Krasnodar
Russian Federation	Gbuz Kkb #2	Krasnodar
Russian Federation	Gbuz Nii Kkb ?1	Krasnodar
Russian Federation	GBUZ Regional clinical hospital ? 2	Krasnodar
Russian Federation	GP #2	Krasnodar
Russian Federation	GP ?15	Krasnodar
Russian Federation	GP ?17	Krasnodar
Russian Federation	GP ?25	Krasnodar
Russian Federation	GP ?27	Krasnodar
Russian Federation	KKB #1	Krasnodar
Russian Federation	Llc "Auris"	Krasnodar
Russian Federation	MBUZ City Polyclinic #11	Krasnodar
Russian Federation	Mbuz Gkb ?1	Krasnodar
Russian Federation	Mbuz Gp #17	Krasnodar
Russian Federation	MBUZ GP number 11	Krasnodar
Russian Federation	MC Ultramed	Krasnodar
Russian Federation	Medical Center "Modern Cardiology"	Krasnodar
Russian Federation	Municipal budgetary health institution "City Polyclinic # 11"	Krasnodar
Russian Federation	MUZ Polyclinic TsRB Poltava	Krasnodar
Russian Federation	Yablonovskaya polyclinic	Krasnodar
Russian Federation	Policlinic ? 1	Krasnoyarsk
Russian Federation	Maikop City Polyclinic ?1	Maykop
Russian Federation	?? ? 210 branch 2	Moscow
Russian Federation	Branch ?1 DGP #94	Moscow
Russian Federation	City polyclinic ? 195	Moscow
Russian Federation	City polyclinic ? 22	Moscow
Russian Federation	Diagnostic Clinical Center ?1	Moscow
Russian Federation	FGBU Federal Clinical Research Centre of Russia's Federal Medical-Biological Agency	Moscow
Russian Federation	Fsbi Enc Mz Rf	Moscow
Russian Federation	Gbuz "Gp #22 Dzm"	Moscow
Russian Federation	GBUZ City polyclinic # 43 DZM filial #3	Moscow
Russian Federation	GP ?219 branch ?4	Moscow
Russian Federation	GP ?45	Moscow
Russian Federation	GP number 176	Moscow
Russian Federation	Hospital SCC RAS in Chernogolovka	Moscow
Russian Federation	Medical Center "Health"	Moscow
Russian Federation	MSU #169	Moscow
Russian Federation	Noginsk Central District Hospital	Moscow
Russian Federation	OOO "Lechebnii center"	Moscow
Russian Federation	Outpatient center of CDC #4	Moscow
Russian Federation	Polyclinic ?52 branch ?1	Moscow
Russian Federation	Polyclinic of the National Science Center of the Russian Academy of Sciences in Chernogolovka	Moscow
Russian Federation	Cst on St.Nizhny Novgorod Oao Rzd	Nizhny Novgorod
Russian Federation	GBUZ NO Pavlovsk CRH	Nizhny Novgorod
Russian Federation	GP #2	Nizhny Novgorod
Russian Federation	Llc "Healthy Little Healer"	Nizhny Novgorod
Russian Federation	MC "Sadko"	Nizhny Novgorod
Russian Federation	MC Dobrii doctor	Nizhny Novgorod
Russian Federation	MC Sadko	Nizhny Novgorod
Russian Federation	Polyclinic ?7 branch 2	Nizhny Novgorod
Russian Federation	Gauz Nso Gkp #1	Novosibirsk
Russian Federation	BUZOO "GP number 12"	Omsk
Russian Federation	City Polyclinic ? 2	Omsk
Russian Federation	Consultative clinic, Regional clinical hospital #2 Rostov region	Rostov
Russian Federation	GP ?16	Rostov
Russian Federation	NUZ Road Clinical Hospital at the station Rostov-Glavnii JSC "Russian Railways"	Rostov
Russian Federation	Polyclinic GB ?7	Rostov
Russian Federation	MBUZ CRB Myasnitskogo region	Rostov-on-Don
Russian Federation	Fsbi "Szfmits Im. Va Almazova" Ministry of Health of Russia	Saint Petersburg
Russian Federation	Gbou Vpo Pspbgmu Im. I.P. Pavlova Ministry of Health of Russia	Saint Petersburg
Russian Federation	GP ?121	Saint Petersburg
Russian Federation	Gbuz Co "Volga Crh"	Samara
Russian Federation	Gbuz Sb Sgb #10	Samara
Russian Federation	GBUZ SO "Samara City Hospital 6"	Samara
Russian Federation	Medical Center on Tupolev	Samara
Russian Federation	Non-State Healthcare Institution "Road Clinical Hospital at Samara Station JSC "Russian Railways"	Samara
Russian Federation	Zhigulevskaya polyclinic	Samara
Russian Federation	City polyclinic ? 2	Saratov
Russian Federation	OGBUZ Polyclinic ?3	Smolensk
Russian Federation	GBUZ SK "Pyatigorsk GKB ? 2"	Stavropol'
Russian Federation	Gbuz Sk Skkkd	Stavropol'
Russian Federation	Regional Clinical Cardiology Dispensary	Stavropol'
Russian Federation	Gaus Mkdts	Tatarstan
Russian Federation	GUZ Citi hospital ?13	Tula
Russian Federation	Guz Gb ?13	Tula
Russian Federation	TOKB KDC	Tula
Russian Federation	First Cardiac Clinic	Tyumen
Russian Federation	GBUZ RB Polyclinic ? 46	Ufa
Russian Federation	GBUZ IN city Polyclinic ?1	Vladimir
Russian Federation	Guz "Polyclinic ? 5"	Volgograd
Russian Federation	Volgograd Regional Clinical Cardiology Center	Volgograd
Russian Federation	BUZ IN "Voronezh city clinical polyclinic #7"	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 months
Secondary	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.	6 months
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)	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
Secondary	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)	3 months, 6 months
Secondary	Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program	Percentage of patients with hospitalizations due to cardiovascular disease	6 months
Secondary	Number of New Cases of Stenocardia During 6 Months of the Program	Percentage of patients with new cases of stenocardia	6 months
Secondary	Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program	Percentage of patients with non-fatal myocardial infarction cases	6 months
Secondary	Number of Cases of Cardio-vascular Death During 6 Months of the Program	Percentage of patients dead due to cardio-vascular death	6 months
Secondary	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.	3 months
Secondary	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.	3 months, 6 months
Secondary	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	3 months, 6 months
Secondary	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	0 months, 3 months
Secondary	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	Baseline, 3 Months, 6 Months