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基于社区的小组信息发布会对阿尔茨海默病二级预防临床试验招募的有效性

The Effectiveness of Small-group Community-based Information Sessions on Clinical Trial Recruitment for Secondary Prevention of Alzheimer's Disease.

作者信息

Tarrant Sarah D, Bardach Shoshana H, Bates Kendra, Nichols Heather, Towner Jacqueline, Tamatha Clay, Caban-Holt Allison, Van-Eldik Linda J, Murphy Richard R, Sperling Reisa, Jicha Gregory A

机构信息

*University of Kentucky Alzheimer Disease Center †Sanders-Brown Center on Aging Departments of ‡Gerontology §Behavioral Science ∥Anatomy and Neurobiology ¶Neurology, University of Kentucky Colleges of Medicine & Public Health, Lexington, KY #Massachusetts Alzheimer Disease Research Center **Department of Neurology, Harvard Medical School, Boston, MA.

出版信息

Alzheimer Dis Assoc Disord. 2017 Apr-Jun;31(2):141-145. doi: 10.1097/WAD.0000000000000151.

Abstract

Effective and practical recruitment strategies are needed to ensure successful recruitment into the Alzheimer disease clinical trials. To facilitate successful recruitment for the NIH-sponsored A4 (Anti-Amyloid treatment in Asymptomatic Alzheimer's disease, NCT02008357) trial for the secondary prevention of Alzheimer disease, we developed a small-group community information session to attract and recruit potential research participants. After a successful media campaign, 213 participants were screened through telephone for eligibility, identifying 127 potential participants. Participants were given the option of a traditional one-on-one recruitment session or a small-group session. One-on-one recruitment was performed for 15 participants requesting this procedure, and yielded an overall recruitment rate of 67% (n=10). Substantially more individuals (n=112, 88%) requested small-group sessions to learn about the study. After attending the small-group informational sessions, 98% of potential participants self-reported a greater understanding of the study; and the recruitment rate from these sessions was 90%. Small-group sessions not only improved recruitment success rates, but also contributed to significantly shorter median time for consent processes (20 vs. 60 min) and reduced staff time spent on persons not recruited. Small-group education programs are an effective strategy for enhancing recruitment success and facilitating practical recruitment into clinical trials with high recruitment demands.

摘要

需要有效的实用招募策略来确保成功招募到阿尔茨海默病临床试验的参与者。为了促进由美国国立卫生研究院资助的A4(无症状阿尔茨海默病的抗淀粉样蛋白治疗,NCT02008357)试验成功招募参与者以进行阿尔茨海默病的二级预防,我们开展了一场小组社区信息交流会来吸引和招募潜在的研究参与者。在一次成功的媒体宣传活动后,通过电话对213名参与者进行了资格筛选,确定了127名潜在参与者。参与者可以选择传统的一对一招募环节或小组招募环节。对15名要求进行一对一招募的参与者进行了一对一招募,总体招募率为67%(n = 10)。更多的人(n = 112,88%)要求参加小组招募环节以了解该研究。在参加了小组信息交流会后,98%的潜在参与者自我报告对该研究有了更深入的了解;这些环节的招募率为90%。小组招募环节不仅提高了招募成功率,还显著缩短了同意过程的中位时间(20分钟对60分钟),并减少了工作人员在未招募人员身上花费的时间。小组教育项目是提高招募成功率以及促进实际招募到对招募要求较高的临床试验参与者的有效策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef14/5116426/f2b5b4d62dac/nihms767139f1.jpg

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本文引用的文献

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The A4 study: stopping AD before symptoms begin?A4研究:在症状出现前阻止阿尔茨海默病?
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