急性冠状动脉综合征后通过短信提高药物依从性和二级预防（TEXTMEDS）：一项随机临床试验方案

TEXT messages to improve MEDication adherence and Secondary prevention (TEXTMEDS) after acute coronary syndrome: a randomised clinical trial protocol.

作者信息

Chow Clara K, Thiagalingam Aravinda, Santo Karla, Kok Cindy, Thakkar Jay, Stepien Sandrine, Billot Laurent, Jan Stephen, Joshi Rohina, Hillis Graham S, Brieger David, Chew Derek P, Rådholm Karin, Atherton John J, Bhindi Ravinay, Collins Nicholas, Coverdale Steven, Hamilton-Craig Christian, Kangaharan Nadarajah, Maiorana Andrew, McGrady Michelle, Shetty Pratap, Thompson Peter, Rogers Anthony, Redfern Julie

机构信息

Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

Department of Cardiology, Westmead Hospital, Westmead, New South Wales, Australia.

出版信息

BMJ Open. 2018 Jan 27;8(1):e019463. doi: 10.1136/bmjopen-2017-019463.

DOI:10.1136/bmjopen-2017-019463

PMID:29374674

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5829769/

Abstract

BACKGROUND

Identifying simple, low-cost and scalable means of supporting lifestyle change and medication adherence for patients following a cardiovascular (CV) event is important.

OBJECTIVE

The TEXTMEDS (TEXT messages to improve MEDication adherence and Secondary prevention) study aims to investigate whether a cardiac education and support programme sent via mobile phone text message improves medication adherence and risk factor levels in patients following an acute coronary syndrome (ACS).

STUDY DESIGN

A single-blind, multicentre, randomised clinical trial of 1400 patients after an ACS with 12 months follow-up. The intervention group will receive multiple weekly text messages that provide information, motivation, support to adhere to medications, quit smoking (if relevant) and recommendations for healthy diet and exercise. The primary endpoint is the percentage of patients who are adherent to cardioprotective medications and the key secondary outcomes are mean systolic blood pressure (BP) and low-density lipoprotein cholesterol. Secondary outcomes will also include total cholesterol, mean diastolic BP, the percentage of participants who are adherent to each cardioprotective medication class, the percentage of participants who achieve target levels of CV risk factors, major vascular events, hospital readmissions and all-cause mortality. The study will be augmented by formal economic and process evaluations to assess acceptability, utility and cost-effectiveness.

SUMMARY

The study will provide multicentre randomised trial evidence of the effects of a text message-based programme on cardioprotective medication adherence and levels of CV risk factors.

ETHICS AND DISSEMINATION

Primary ethics approval was received from Western Sydney Local Health District Human Research Ethics Committee (HREC2012/12/4.1 (3648) AU RED HREC/13/WMEAD/15). Results will be disseminated via peer-reviewed publications and presentations at international conferences.

TRIAL REGISTRATION NUMBER

ACTRN12613000793718; Pre-results.

摘要

背景

确定支持心血管（CV）事件后患者改变生活方式和坚持服药的简单、低成本且可扩展的方法很重要。

目的

TEXTMEDS（通过短信改善药物依从性和二级预防）研究旨在调查通过手机短信发送的心脏教育和支持计划是否能提高急性冠状动脉综合征（ACS）患者的药物依从性和危险因素水平。

研究设计

一项针对1400例ACS患者的单盲、多中心、随机临床试验，随访12个月。干预组将每周收到多条短信，内容包括提供信息、激励、支持坚持服药、戒烟（如适用）以及健康饮食和锻炼建议。主要终点是坚持服用心脏保护药物的患者百分比，关键次要结局是平均收缩压（BP）和低密度脂蛋白胆固醇。次要结局还将包括总胆固醇、平均舒张压、坚持每种心脏保护药物类别的参与者百分比、达到CV危险因素目标水平的参与者百分比、主要血管事件、住院再入院率和全因死亡率。该研究将通过正式的经济和过程评估进行补充，以评估可接受性、效用和成本效益。