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基于短信干预对冠心病患者进行心血管疾病持续预防的烟草、运动与饮食信息(TEXT ME)试验的设计与原理:一项随机对照试验方案

Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol.

作者信息

Chow C K, Redfern J, Thiagalingam A, Jan S, Whittaker R, Hackett M, Graves N, Mooney J, Hillis G S

机构信息

The George Institute for Global Health, Sydney, Australia.

出版信息

BMJ Open. 2012 Jan 19;2(1):e000606. doi: 10.1136/bmjopen-2011-000606. Print 2012.

DOI:10.1136/bmjopen-2011-000606
PMID:22267690
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3263439/
Abstract

Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease, providing access to such interventions is a major challenge. This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk. Methods and analysis Randomised controlled trial with 6 months of follow-up to evaluate the feasibility, acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care. A total of 720 patients with coronary artery disease will be randomised to either standard care or the TEXT ME intervention. The intervention group will receive multiple weekly text messages that provide information, motivation, support to quit smoking (if relevant) and recommendations for healthy diets and exercise. The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months. Secondary end points include a change in systolic blood pressure, smoking status, quality of life, medication adherence, waist circumference, physical activity levels, nutritional status and mood at 6 months. Process outcomes related to acceptability and feasibility of TEXT ME will also be collected. Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee-Westmead. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. Clinical trials registration number ACTRN12611000161921.

摘要

背景

尽管支持生活方式改变是预防心血管疾病患者再次发病的有效方法,但提供此类干预措施面临重大挑战。本研究旨在调查通过手机短信发送的关于行为改变的简单提醒是否能降低心血管风险。

方法与分析

一项随机对照试验,随访6个月,以评估通过手机短信发送的重复生活方式提醒与常规护理相比,在心血管风险方面的可行性、可接受性及效果。总共720例冠心病患者将被随机分为标准护理组或“短信提醒我”干预组。干预组将每周收到多条短信,内容包括信息、激励、戒烟支持(如适用)以及健康饮食和运动建议。主要终点是6个月时血浆低密度脂蛋白胆固醇的变化。次要终点包括6个月时收缩压、吸烟状况、生活质量、药物依从性、腰围、身体活动水平、营养状况和情绪的变化。还将收集与“短信提醒我”的可接受性和可行性相关的过程性结果。

伦理与传播

已获得西悉尼地方卫生网络韦斯特米德人类研究伦理委员会的主要伦理批准。研究结果将通过包括同行评审出版物和国际会议报告在内的常规科学论坛进行传播。

临床试验注册号

ACTRN12611000161921

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef11/3263439/6535f3bb5462/bmjopen-2011-000606fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef11/3263439/6535f3bb5462/bmjopen-2011-000606fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef11/3263439/6535f3bb5462/bmjopen-2011-000606fig1.jpg

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