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

Abstract

Background: Maintaining sustained adherence to medication for optimal management of chronic noninfectious diseases, such as atherosclerotic vascular disease, is a well-documented therapeutic challenge.

Objective: The DIAPAsOn study was a 6-month, multicenter prospective observational study in the Russian Federation that examined adherence to a preparation of highly purified omega-3 polyunsaturated fatty acids (Omacor) in 2167 adult patients with a history of recent myocardial infarction or endogenous hypertriglyceridemia.

Methods: A feature of DIAPAsOn was the use of a bespoke electronic patient engagement and data collection system to monitor adherence. Adherence was also monitored by enquiry at clinic visits. A full description of the study's aims and methods has appeared in JMIR Research Protocols.

Results: The net average reduction from baseline in both total and low-density lipoprotein cholesterol was approximately 1 mmol/L and the net average increase in high-density lipoprotein cholesterol was 0.2 (SD 0.53) mmol/L (P<.001 for all outcomes vs baseline). The mean triglyceride level was 3.0 (SD 1.3) mmol/L at visit 1, 2.0 (SD 0.9) mmol/L at visit 2, and 1.7 (SD 0.7) mmol/L at visit 3 (P<.001 for later visits vs visit 1). The percentage of patients with a triglyceride level <1.7 mmol/L rose from 13.1% (282/2151) at baseline to 54% (1028/1905) at the end of the study. Digital reporting of adherence was registered by 8.3% (180/2167) of patients; average scores indicted poor adherence. However, a clinic-based enquiry suggested high levels of adherence. Data on health-related quality of life accrued from digitally engaged patients identified improvements among patients reporting high adherence to study treatment, but patient numbers were small.

Conclusions: The lipid and lipoprotein findings indicate that Omacor had nominally favorable effects on the blood lipid profile. Less than 10% of patients enrolled in DIAPAsOn used the bespoke digital platform piloted in the study, and the level of self-reported adherence to medication by these patients was also low. Reasons for this low uptake and adherence are unclear. Better adherence was recorded in clinical reports.

Trial registration: ClinicalTrials.gov NCT03415152; https://ichgcp.net/clinical-trials-registry/NCT03415152.

Keywords: cardiac; cardiac health; cardiology; clinical report; digital health; eHealth; electronic patient engagement; heart; myocardial infarction; patient engagement; primary care; research; treatment; treatment adherence.

Conflict of interest statement

Conflicts of Interest: GPA has not received any educational grants from any companies and has not received any fees or nonfinancial support from health care companies related to this study. GPA reports receiving honoraria for professional lectures at regional and national medical educational events from health care companies including Abbott, Bayer, Boehringer Ingelheim, and Servier. AGA has not received any educational grants from any companies and has not received any fees or nonfinancial support from health care companies related to this study. AGA reports receiving honoraria for professional lectures at regional and national medical educational events from health care companies including Abbott, Bayer, Boehringer Ingelheim, and Servier. FTA and TVF declare no conflicts of interest.

©Gregory P Arutyunov, Alexander G Arutyunov, Fail T Ageev, Tatiana V Fofanova. Originally published in JMIR Cardio (https://cardio.jmir.org), 25.07.2022.

Figures

Figure 1

Patient subsets in the DIAPAsOn study. Numbers in the form “xx/yy” indicate patients who did not/did use the study’s digital tools.

Figure 2

Distribution of adherence categories for (A) the overall population (B), the post–myocardial infarction subgroup, and (C), the hypertriglyceridemia subgroup, based on responses to the National Questionnaire of Treatment Compliance.

Figure 3

In-study changes in blood lipids in (A) the overall population (B), the post–myocardial infarction subgroup, and (C), the hypertriglyceridemia subgroup. TC: total cholesterol; TG: triglyceride; LDL: low-density lipoprotein; HDL: high-density lipoprotein.