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研究背景和设计:MyHEART 研究:一项针对青年高血压患者的自我管理随机对照试验。

Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial.

机构信息

Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1685 Highland Avenue, 5158 Medical Foundation Centennial Building, Madison, WI 53705-2281, USA; Health Innovation Program, University of Wisconsin School of Medicine and Public Health, 800 University Bay Drive, Suite 210, Madison, WI 53705, USA.

Aurora Health Care Department of Family Medicine, Family Care Center, 1020 N 12(th) Street, Milwaukee, WI 53233, USA.

出版信息

Contemp Clin Trials. 2019 Mar;78:88-100. doi: 10.1016/j.cct.2019.01.010. Epub 2019 Jan 21.

DOI:10.1016/j.cct.2019.01.010
PMID:30677485
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC6387836/
Abstract

Young adults (18-39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension self-management programs are recommended to improve control, but have been targeted to middle-aged and older populations. Young adults need hypertension self-management programs (i.e., home blood pressure monitoring and lifestyle modifications) tailored to their unique needs to lower blood pressure and reduce the risks and medication burden they may face over a lifetime. To address the unmet need in hypertensive care for young adults, we developed MyHEART (My Hypertension Education And Reaching Target), a multi-component, theoretically-based intervention designed to achieve self-management among young adults with uncontrolled hypertension. MyHEART is a patient-centered program, based upon the Self-Determination Theory, that uses evidence-based health behavior approaches to lower blood pressure. Therefore, the objective of this study is to evaluate MyHEART's impact on changes in systolic and diastolic blood pressure compared to usual care after 6 and 12 months in 310 geographically and racially/ethnically diverse young adults with uncontrolled hypertension. Secondary outcomes include MyHEART's impact on behavioral outcomes at 6 and 12 months, compared to usual clinical care (increased physical activity, decreased sodium intake) and to examine whether MyHEART's effects on self-management behavior are mediated through variables of perceived competence, autonomy, motivation, and activation (mediation outcomes). MyHEART is one of the first multicenter, randomized controlled hypertension trials tailored to young adults with primary care. The design and methodology will maximize the generalizability of this study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03158051.

摘要

年轻人(18-39 岁)患有高血压,其终生患心血管疾病的风险更高。然而,不到 50%的美国年轻人能控制高血压。建议实施高血压自我管理计划来改善控制,但这些计划的目标人群是中年及以上人群。年轻人需要针对其独特需求量身定制的高血压自我管理计划(即家庭血压监测和生活方式改变)来降低血压,并降低他们可能终生面临的风险和药物负担。为了满足年轻人高血压管理方面的未满足需求,我们开发了 MyHEART(我的高血压教育和达标),这是一个多组件、基于理论的干预措施,旨在实现血压控制不佳的年轻成年人的自我管理。MyHEART 是一个以患者为中心的计划,基于自我决定理论,使用基于证据的健康行为方法来降低血压。因此,本研究的目的是评估 MyHEART 在 6 个月和 12 个月时与常规护理相比对 310 名地理和种族/民族多样化的血压控制不佳的年轻成年人的收缩压和舒张压变化的影响。次要结局包括 MyHEART 在 6 个月和 12 个月时与常规临床护理(增加身体活动、减少钠摄入量)相比对行为结局的影响,并检查 MyHEART 对自我管理行为的影响是否通过感知能力、自主性、动机和激活等变量来介导(中介结局)。MyHEART 是第一个针对初级保健的年轻成年人量身定制的多中心、随机对照高血压试验。该设计和方法将最大限度地提高本研究的普遍性。试验注册:ClinicalTrials.gov 标识符:NCT03158051。

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