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比较血压管理应用程序(BPMAP)与常规护理在30至60岁原发性高血压患者自我管理及治疗依从性方面的有效性:一项随机对照试验的研究方案

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial.

作者信息

Ashoorkhani Mahnaz, Bozorgi Ali, Majdzadeh Reza, Hosseini Hamed, Yoonessi Ali, Ramezankhani Ali, Eftekhar Hassan

机构信息

Department of Health Education and Promotion, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.

Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Trials. 2016 Oct 21;17(1):511. doi: 10.1186/s13063-016-1638-0.

Abstract

BACKGROUND

Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment.

METHODS/DESIGN: A two-arm, parallel-design randomized controlled clinical trial will be conducted on 30 to 60 year-old patients with primary hypertension who are attending the Tehran Heart Center. One hundred and thirty-two (132) patients will be randomly assigned to the intervention and control (usual method) groups. The most important inclusion criteria are, having primary hypertension and being pharmacologically treated for it, and not having developed the complications of hypertension, such as myocardial infarction, cerebral stroke and cardiac insufficiency. The participants should be able to read Persian and be able to use the application. The most important outcomes of the study include adherence to treatment, weight control, and regular monitoring of blood pressure which are assessed in the primary assessment (baseline data questionnaire) and again at the 8 and 24 weeks. The intervention is a mobile application that has capabilities such as reminders and scientific and supportive information.

DISCUSSION

This application has been programmed to reduce many of the nonadherence factors of hypertension treatment. Therefore, the findings may contribute to a rise in adherence to treatment. If proven to have an appropriate impact, it may be extended for use in the national hypertension control plan.

TRIAL REGISTRATION

This study was registered in the Iran Randomized Clinical Trial Center under the number IRCT2015111712211N2 on 1 January 2016.

摘要

背景

高血压是心血管疾病最重要且广为人知的危险因素之一。遗憾的是,尽管有有效的治疗方法,但患者对规律用药及其他非药物治疗(如改善生活方式)的依从性往往较差。本研究评估一种教育性支持干预措施——以血压管理应用程序(BPMAP)的形式——对原发性高血压患者自我管理、控制高血压决定因素及治疗依从性的有效性。

方法/设计:将对就诊于德黑兰心脏中心的30至60岁原发性高血压患者进行一项双臂、平行设计的随机对照临床试验。132名患者将被随机分配至干预组和对照组(常规方法组)。最重要的纳入标准是患有原发性高血压且正在接受药物治疗,未发生高血压并发症,如心肌梗死、脑卒中和心功能不全。参与者应能够阅读波斯语并能使用该应用程序。研究的最重要结局包括治疗依从性、体重控制和血压定期监测,这些将在初次评估(基线数据问卷)时以及第8周和第24周再次进行评估。干预措施是一个具有提醒功能以及科学和支持性信息等功能的移动应用程序。

讨论

该应用程序旨在减少高血压治疗中许多不依从因素。因此,研究结果可能有助于提高治疗依从性。如果被证明有适当影响,它可能会被推广用于国家高血压控制计划。

试验注册

本研究于2016年1月1日在伊朗随机临床试验中心注册,注册号为IRCT2015111712211N2。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a87/5073944/ba32364f98c1/13063_2016_1638_Fig1_HTML.jpg

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