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比较改善冠心病退伍军人药物依从性的移动健康策略(Mobile4Meds):一项混合方法研究的方案

Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

作者信息

Park Linda G, Collins Eileen G, Shim Janet K, Whooley Mary A

机构信息

Department of Veterans Affairs, Community Health Systems, University of California, San Francisco, San Francisco, CA, United States.

Edward Hines Jr., VA Hospital, Department of Biobehavioral Health Science, University of Illinois at Chicago, Chicago, IL, United States.

出版信息

JMIR Res Protoc. 2017 Jul 18;6(7):e134. doi: 10.2196/resprot.7327.

Abstract

BACKGROUND

Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence.

OBJECTIVE

The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT).

METHODS

We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports.

RESULTS

Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018.

CONCLUSIONS

Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03022669.

摘要

背景

坚持服用抗血小板药物对于预防经皮冠状动脉介入治疗(PCI)后危及生命的并发症(如支架血栓形成)至关重要,但到12个月时,不依从率在21%至57%之间。通过短信或移动应用程序提供的移动干预措施是促进行为改变和提高药物依从性的一种实用且经济的策略。

目的

“移动4药物”研究旨在确定与提供给所有退伍军人的教育网站对照相比,短信或移动应用程序是否能提高急性冠状动脉综合征(ACS)或PCI患者的抗血小板治疗依从性。该研究的三个目标是:(1)通过焦点小组确定促进药物依从性的短信内容和频率偏好;(2)通过对所有商业上可用的药物依从性应用程序进行内容分析以及以可用性为中心的焦点小组,确定最以患者为中心的促进依从性的应用程序;(3)通过随机临床试验(RCT)比较ACS/PCI后退伍军人的抗血小板药物依从性。

方法

我们将采用混合方法设计,利用焦点小组实现前两个目标(N = 32)。患者被随机分配到三个组之一后将被随访12个月:(1)定制短信组,(2)移动应用程序组,或(3)网站对照组(N = 225)。药物依从性将通过电子监测设备、药房记录和自我报告进行测量。

结果

焦点小组的招募工作目前正在进行中。我们预计在2018年初招募RCT的患者。

结论

使用退伍军人设计的方案确定移动技术促进药物依从性的疗效将对退伍军人健康和公共卫生产生重大影响,特别是对于需要严格坚持药物治疗的慢性病患者。

试验注册

ClinicalTrials.gov NCT03022669。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7016/5539386/4094d1ee0ee1/resprot_v6i7e134_fig1.jpg

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