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一项基于实践的随机对照试验,旨在提高拉丁裔高血压患者的药物依从性:一项随机对照试验的研究方案

A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial.

作者信息

Schoenthaler Antoinette, De La Calle Franzenith, Barrios-Barrios Miguel, Garcia Aury, Pitaro Maria, Lum Audrey, Rosal Milagros

机构信息

Department of Population Health, Center for Healthful Behavior Change, New York University School of Medicine, 227 East 30th Street, 634, New York, NY, 10016, USA.

Union Health Center, New York, NY, 10001, USA.

出版信息

Trials. 2015 Jul 2;16:290. doi: 10.1186/s13063-015-0815-x.

Abstract

BACKGROUND

Latinos experience disproportionately higher rates of uncontrolled hypertension as compared to Blacks and Whites. While poor adherence is a major contributor to disparities in blood pressure control, data in Latino patients are scant. More importantly, translation of interventions to improve medication adherence in community-based primary care practices, where the majority of Latino patients receive their care is non-existent.

METHODS

Using a randomized controlled design, this study evaluates the effectiveness of a culturally tailored, practice-based intervention compared to usual care on medication adherence, among 148 Latino patients with uncontrolled hypertension who are non-adherent to their antihypertensive medications. Bilingual medical assistants trained as Health Coaches deliver the intervention using an electronic medical record system-embedded adherence script. Patients randomized to the intervention group receive patient-centered counseling with a Health Coach to develop individualized self-monitoring strategies to overcome barriers and improve adherence behaviors. Health Coach sessions are held biweekly for the first 3 months (6 sessions total) and then monthly for the remaining 3 months (3 sessions total). Patients randomized to the usual care group receive standard hypertension treatment recommendations as determined by their primary care providers. The primary outcome is the rate of medication adherence at 6 months. The secondary outcome is reduction in systolic and diastolic blood pressure at 6 months.

DISCUSSION

If successful, findings from this study will provide salient information on the translation of culturally tailored, evidence-based interventions targeted at medication adherence and blood pressure control into practice-based settings for this high-risk population.

TRIAL REGISTRATION

NCT01643473 on 16 July 2012.

摘要

背景

与黑人和白人相比,拉丁裔人群中未得到控制的高血压发病率高得不成比例。尽管依从性差是血压控制差异的主要原因,但拉丁裔患者的数据却很少。更重要的是,在大多数拉丁裔患者接受治疗的社区基层医疗实践中,将改善药物依从性的干预措施转化应用的情况并不存在。

方法

本研究采用随机对照设计,对148名未坚持服用抗高血压药物且血压未得到控制的拉丁裔患者,评估一种针对文化定制的、基于实践的干预措施与常规护理相比在药物依从性方面的效果。接受健康教练培训的双语医疗助理使用嵌入电子病历系统的依从性脚本实施干预。随机分配到干预组的患者会与健康教练进行以患者为中心的咨询,以制定个性化的自我监测策略,克服障碍并改善依从行为。健康教练课程在前3个月每两周进行一次(共6次课程),然后在剩余3个月每月进行一次(共3次课程)。随机分配到常规护理组的患者接受其初级保健提供者确定的标准高血压治疗建议。主要结局是6个月时的药物依从率。次要结局是6个月时收缩压和舒张压的降低情况。

讨论

如果研究成功,本研究结果将为针对这一高危人群,将针对文化定制的、基于证据的药物依从性和血压控制干预措施转化应用到基于实践的环境中提供重要信息。

试验注册

2012年7月16日,NCT01643473。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb8f/4488119/a96cd4476893/13063_2015_815_Fig1_HTML.jpg

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