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使用移动健康技术(应用程序)对动脉粥样硬化性颈动脉斑块进行可视化呈现对二级预防治疗依从性的影响:一项随机对照试验的研究方案。

Effect of visual presentation of atherosclerotic carotid plaque on adherence to secondary preventive therapy using mHealth technologies ( app): Study protocol for a randomized controlled trial.

作者信息

Ullrich Greta, Dönmez Alina, Mahabadi Amir A, Bäuerle Alexander, Knuschke Ramtin, Paldán Katrin, Schnaubert Lenka, Rammos Christos, Rassaf Tienush

机构信息

Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany.

Clinic for Psychosomatic Medicine and Psychotherapy, LVR, University Essen, Hufelandstr. 55, 45147 Essen, Germany.

出版信息

Heliyon. 2023 Feb 27;9(3):e14052. doi: 10.1016/j.heliyon.2023.e14052. eCollection 2023 Mar.

DOI:10.1016/j.heliyon.2023.e14052
PMID:36915490
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10006680/
Abstract

BACKGROUND

Cardiovascular disease is the major cause of death worldwide. Although knowledge regarding diagnosing and treating cardiovascular disease has increased dramatically, secondary prevention remains insufficiently implemented due to failure among affected individuals to adhere to guideline recommendations. This has continued to lead to high morbidity and mortality rates. Involving patients in their healthcare and facilitating their active roles in their chronic disease management is an opportunity to meet the needs of the increasing number of cardiovascular patients. However, simple recall of advice regarding a more preventive lifestyle does not affect sustainable behavioral lifestyle changes. We investigate the effect of plaque visualization combined with low-threshold daily lifestyle tasks using the smartphone app to evaluate change in cardiovascular risk profile.

METHODS

and study design: This randomized, controlled clinical trial includes 240 participants with ultrasound evidence of atherosclerotic plaque in one or both carotid arteries, defined as focal thickening of the vessel wall measuring 50% more than the regular vessel wall. A criterion for participation is access to a smartphone suitable for app usage. The participants are randomly assigned to an intervention or a control group. While both groups receive the standard of care, the intervention group has additional access to the app during the 12-month follow-up. The app includes daily tasks that promote a healthier lifestyle in the areas of smoking cessation, medication adherence, physical activity, and diet. The impact of plaque visualization and app use on the change in cardiovascular risk profile is assessed by SCORE2. Feasibility and effectiveness of the app are evaluated using standardized and validated measures for patient feedback.

ETHICS AND DISSEMINATION

This clinical trial is approved by the ethics committee of the University of Duisburg-Essen (Germany). Study results will be disseminated at conferences and in peer-reviewed journals. Information regarding the PreventiPlaque app is available via print media, social media channels, and on the authors' websites.

摘要

背景

心血管疾病是全球主要的死亡原因。尽管在心血管疾病的诊断和治疗方面的知识有了显著增加,但由于患者未能遵循指南建议,二级预防仍未得到充分实施。这继续导致高发病率和死亡率。让患者参与其医疗保健并促进他们在慢性病管理中的积极作用是满足日益增多的心血管疾病患者需求的一个机会。然而,简单地回忆关于更具预防性的生活方式的建议并不会影响可持续的行为生活方式改变。我们研究使用智能手机应用程序将斑块可视化与低门槛日常生活任务相结合,以评估心血管风险状况变化的效果。

方法和研究设计

这项随机对照临床试验包括240名参与者,他们的一侧或双侧颈动脉有动脉粥样硬化斑块的超声证据,定义为血管壁局部增厚超过正常血管壁50%。参与的一个标准是能够使用适合该应用程序的智能手机。参与者被随机分配到干预组或对照组。两组都接受标准治疗,干预组在12个月的随访期间还可以使用该应用程序。该应用程序包括在戒烟、药物依从性、体育活动和饮食等方面促进更健康生活方式的日常任务。通过SCORE2评估斑块可视化和应用程序使用对心血管风险状况变化的影响。使用标准化和经过验证的患者反馈措施评估该应用程序的可行性和有效性。

伦理与传播

这项临床试验已获得德国杜伊斯堡-埃森大学伦理委员会的批准。研究结果将在会议和同行评审期刊上发表。有关PreventiPlaque应用程序的信息可通过印刷媒体、社交媒体渠道以及作者的网站获取。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/0735871aa8ee/gr6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/c0df5c56696d/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/47d9c4731d1b/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/4f9c05b7b141/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/a66be83c54c2/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/861de93ad5c1/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/0735871aa8ee/gr6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/c0df5c56696d/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/47d9c4731d1b/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/4f9c05b7b141/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/a66be83c54c2/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/861de93ad5c1/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8da/10006680/0735871aa8ee/gr6.jpg

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