用于提高冠心病患者用药依从性的药物提醒应用程序（MedApp-CHD）研究：一项随机对照试验方案

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol.

作者信息

Santo Karla, Chow Clara K, Thiagalingam Aravinda, Rogers Kris, Chalmers John, Redfern Julie

机构信息

Cardiovascular Division, The George Institute for Global Health, Sydney, Australia.

Sydney Medical School, University of Sydney, Sydney, Australia.

出版信息

BMJ Open. 2017 Oct 8;7(10):e017540. doi: 10.1136/bmjopen-2017-017540.

DOI:10.1136/bmjopen-2017-017540

PMID:28993388

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5640083/

Abstract

INTRODUCTION

The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence.

METHODS AND ANALYSIS

Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps.

ETHICS AND DISSEMINATION

Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums.

TRIAL REGISTRATION NUMBER

ACTRN12616000661471; Pre-results.

摘要

引言

应用商店中可用的智能手机健康应用程序数量不断增加，使这些应用程序成为帮助减少全球长期药物治疗不依从性问题的一个有前景的工具。然而，迄今为止，几乎没有证据表明现有的药物提醒应用程序是有效的。本研究旨在确定与冠心病（CHD）患者的常规护理相比，药物提醒应用程序对心血管药物依从性的影响，并确定与基本应用程序相比，高级应用程序是否与更高的依从性相关。

方法与分析

一项随机对照试验，随访3个月，以评估与常规护理相比，药物提醒应用程序对药物依从性的可行性和有效性。预计将156例冠心病患者随机分为三组之一（常规护理组、基本药物提醒应用程序组和高级药物提醒应用程序组）。常规护理组将接受冠心病的标准护理，无法使用药物提醒应用程序。基本药物提醒应用程序组将可以使用具有提供简单每日提醒且无交互功能这一基本功能的药物提醒应用程序。高级药物提醒应用程序组将可以使用具有额外交互和可定制功能的药物提醒应用程序。主要结局是在3个月时通过八项Morisky药物依从性量表测量的药物依从性。次要结局包括血压和胆固醇水平的临床测量以及药物知识。还将进行过程评估，通过评估应用程序的可接受性、实用性和参与度来评估干预措施的可行性。