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用于检查患者对仅处方使用的ω-3多不饱和脂肪酸疗法依从性以降低心血管风险的数字技术工具:一项前瞻性观察性研究方案及初步人口统计学分析

Digital Technology Tools to Examine Patient Adherence to a Prescription-Only Omega-3 Polyunsaturated Fatty Acid Therapy To Mitigate Cardiovascular Risk: Protocol for a Prospective Observational Study and Preliminary Demographic Analysis.

作者信息

Arutyunov Gregory P, Arutyunov Alexander G, Ageev Fail T, Fofanova Tatiana V

机构信息

Pirogov Russian National Research Medical University, Moscow, Russian Federation.

National Medical Research Center for Cardiology, Moscow, Russian Federation.

出版信息

JMIR Res Protoc. 2021 Aug 30;10(8):e29061. doi: 10.2196/29061.

DOI:10.2196/29061
PMID:34459746
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8438613/
Abstract

BACKGROUND

Sustained adherence and persistence with prescription medications is considered essential to achieve maximal treatment benefit for patients with major chronic, noncommunicable diseases such as hyperlipidemia and lipid-associated cardiovascular disease. It is widely documented, however, that many patients with these conditions have poor long-term adherence to their treatments. The population of Russia is affected by poor adherence in the same ways as populations elsewhere and continues to have high rates of cardiovascular disease.

OBJECTIVE

The purpose of this study was to examine patient adherence to a prescription-only preparation of highly purified omega-3 polyunsaturated fatty acids (1.2 to 1 eicosapentaenoic acid to docosahexaenoic ratio, 90% purity) in a large sample of patients at risk for cardiovascular diseases using digital technology to monitor patient behavior and as an outreach facility for patient education and engagement.

METHODS

We conducted a 6-month prospective observational study (DIAPAsOn) at >100 centers in the Russian Federation. A bespoke electronic data capture and patient engagement system were developed with a well-established Russian technology supplier that enables information obtained during clinic visits to be supplemented by remote patient self-reporting. Other aspects of the program included raising patients' awareness about their condition via educational materials available in personal patient accounts in the electronic system.

RESULTS

From an initial cohort of 3000 patients, a safety population of 2572 patients (age: mean 60 years) with an equal proportion of men and women has been characterized. There was widespread concomitant cardiovascular pathology and commensurate use of multiple classes of cardiovascular medication, notably lipid-modifying and antihypertensive drugs. The program was completed by 1975 patients, of whom 780 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for secondary prevention after myocardial infarction and 1195 were prescribed highly purified omega-3 polyunsaturated fatty acid supplements for hypertriglyceridemia. Data collection and analysis have been completed.

CONCLUSIONS

DIAPAsOn will provide insights into patient adherence with prescription-grade omega-3 polyunsaturated fatty acid therapy and perspectives on the role of mobile technology in monitoring and encouraging adherence to therapy.

摘要

背景

对于患有高脂血症和脂质相关心血管疾病等主要慢性非传染性疾病的患者而言,持续坚持服用处方药被认为是实现最大治疗益处的关键。然而,有大量文献记载,许多患有这些疾病的患者长期治疗依从性较差。俄罗斯民众与其他地区的人群一样,也受到依从性差的影响,心血管疾病发病率持续居高不下。

目的

本研究旨在通过数字技术监测患者行为,并作为患者教育和参与的外展工具,在大量有心血管疾病风险的患者样本中,考察患者对仅凭处方使用的高纯度ω-3多不饱和脂肪酸制剂(二十碳五烯酸与二十二碳六烯酸比例为1.2:1,纯度90%)的依从性。

方法

我们在俄罗斯联邦100多个中心开展了一项为期6个月的前瞻性观察性研究(DIAPAsOn)。与一家成熟的俄罗斯技术供应商合作开发了定制的电子数据采集和患者参与系统,该系统能使门诊就诊时获取的信息通过患者远程自我报告得到补充。该项目的其他方面包括通过电子系统中个人患者账户提供的教育材料提高患者对自身病情的认识。

结果

从最初的3000名患者队列中,确定了一个由2572名患者组成的安全人群(年龄:平均60岁),男女比例相等。患者普遍伴有心血管病变,并相应地使用了多种心血管药物,尤其是调脂药和抗高血压药。1975名患者完成了该项目,其中780名被处方高纯度ω-3多不饱和脂肪酸补充剂用于心肌梗死后的二级预防,1195名被处方高纯度ω-3多不饱和脂肪酸补充剂用于治疗高甘油三酯血症。数据收集和分析已完成。

结论

DIAPAsOn将为患者对处方级ω-3多不饱和脂肪酸治疗的依从性以及移动技术在监测和鼓励治疗依从性方面的作用提供见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/fbac46bbe52d/resprot_v10i8e29061_fig8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/3184132f98bc/resprot_v10i8e29061_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/202f12d7a16e/resprot_v10i8e29061_fig2.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/427312cf32a3/resprot_v10i8e29061_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/b2b9446ee8b5/resprot_v10i8e29061_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/eed50187483a/resprot_v10i8e29061_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/687278f6fa0f/resprot_v10i8e29061_fig7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/fbac46bbe52d/resprot_v10i8e29061_fig8.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/3184132f98bc/resprot_v10i8e29061_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/202f12d7a16e/resprot_v10i8e29061_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/dba9e68b2de2/resprot_v10i8e29061_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/427312cf32a3/resprot_v10i8e29061_fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/b2b9446ee8b5/resprot_v10i8e29061_fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/eed50187483a/resprot_v10i8e29061_fig6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/687278f6fa0f/resprot_v10i8e29061_fig7.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15eb/8438613/fbac46bbe52d/resprot_v10i8e29061_fig8.jpg

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