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针对非裔美国男性降低中风风险的目标管理(TEAM)干预措施:一项前瞻性随机对照试验的原理与研究设计

The Targeted Management (TEAM) Intervention for Reducing Stroke Risk in African American Men: Rationale and Study Design of a Prospective Randomized Controlled Trial.

作者信息

Still Carolyn H, Burant Chris, Moore Shirley, Einstadter Doug, Killion Cheryl, Modlin Charles, Sundararajan Sophia, Thornton John D, Wright Jackson T, Sajatovic Martha

机构信息

Frances Payne Bolton, School of Nursing, Case Western Reserve University, Cleveland, OH, USA.

Center for Health Care Research and Policy, Case Western Reserve University, Cleveland, OH, USA.

出版信息

J Multidiscip Healthc. 2021 Feb 23;14:513-522. doi: 10.2147/JMDH.S288753. eCollection 2021.

Abstract

BACKGROUND

African American (AA) male survivors of strokes or transient ischemic attacks (TIA) have the highest risk of recurrent stroke when compared to other racial-ethnic men. However, there is a paucity of evidence-based strategies, including organizational, educational, or behavioral interventions, that targets secondary stroke risk reduction in AA men.

METHODS

Targeted Management for Reducing Stroke Risk (TEAM) is an ongoing, 6-month prospective, randomized controlled trial that will determine whether a curriculum-guided self-management approach, using peer dyads (men who had a stroke or TIA and their care partners) will improve post-stroke care in AA men.

RESULTS

The study sample will consist of 160 AA men who have experienced a stroke or TIA within 5 years, randomized to TEAM or Wait-list control group. The primary outcome changes in systolic blood pressure (BP) and high-density lipoprotein (HDL), while secondary outcomes include diastolic BP, total cholesterol, low-density lipoprotein, triglycerides, and glycemic control for diabetics. We hypothesize that AA men in TEAM will have significantly lower systolic BP and higher HDL when compared to AA men in the Wait-list control group at 6-month.

CONCLUSION

Persistent disparities for stroke burden in AA men highlight the need for novel interventions to promote secondary stroke-risk reduction. Building on promising pilot data, TEAM uses a group format, with a nurse and patient co-led intervention focused on AA men and family needs, practice in problem-solving, and attention to emotional and role management. In addition, the TEAM approach may help reduce stroke risk factors and health disparities in AA men.

CLINICALTRIALSGOV IDENTIFIER

NCT04402125.

摘要

背景

与其他种族的男性相比,非裔美国(AA)男性中风或短暂性脑缺血发作(TIA)幸存者复发中风的风险最高。然而,针对降低AA男性二次中风风险的循证策略,包括组织、教育或行为干预措施却很匮乏。

方法

降低中风风险的针对性管理(TEAM)是一项正在进行的为期6个月的前瞻性随机对照试验,该试验将确定一种以课程为导向的自我管理方法,即使用同伴二元组(中风或TIA患者及其护理伙伴)是否能改善AA男性的中风后护理。

结果

研究样本将包括160名在5年内经历过中风或TIA的AA男性,随机分为TEAM组或等待名单对照组。主要结局为收缩压(BP)和高密度脂蛋白(HDL)的变化,次要结局包括舒张压、总胆固醇、低密度脂蛋白、甘油三酯以及糖尿病患者的血糖控制。我们假设,与等待名单对照组的AA男性相比,TEAM组的AA男性在6个月时收缩压会显著降低,HDL会升高。

结论

AA男性中风负担方面持续存在的差异凸显了采取新型干预措施以促进降低二次中风风险的必要性。基于有前景的试点数据,TEAM采用小组形式,由护士和患者共同主导干预,关注AA男性及其家庭需求、问题解决实践以及对情绪和角色管理的关注。此外,TEAM方法可能有助于降低AA男性的中风风险因素和健康差异。

临床试验注册标识符

NCT04402125。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b1ee/7914069/328653e06516/JMDH-14-513-g0001.jpg

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