Recruitment and enrollment of African Americans into health promoting programs: the effects of health promoting programs on cardiovascular disease risk study.
Recruitment and enrollment of African Americans into health promoting programs: the effects of health promoting programs on cardiovascular disease risk study.
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非裔美国人的招募和登记参加健康促进计划：健康促进计划对心血管疾病风险研究的影响。
DOI：
10.1080/13557858.2018.1458074
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发表时间：
2020
影响因子：
3.1
通讯作者：
MarshallJr,GailenD
中科院分区：
文献类型：
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作者：
Okhomina,VictoriaI;Seals,SamanthaR;MarshallJr,GailenD
目的：随机对照试验（RCT）通常采用多种招募方法来吸引参与者，但必须特别注意纳入代表性不足的人群。我们研究了现有观察性研究中的招募如何影响非裔美国人参加随机对照试验（其中包括基于瑜伽的干预措施）的招募。我们特别报告了健康促进计划 (HPP) 对心血管疾病风险的影响 (NCT02019953) 的招募成功，这是第一个仅针对非裔美国人的基于瑜伽的临床试验。 设计：为了招募参与者，专门在杰克逊心脏研究 (JHS) 队列中实施了多方面的招募策略。 HPP 通过直接邮寄、在 JHS 研究设施周围张贴标志和传单以及通过 JHS 年度后续访谈从 JHS 队列中招募。 结果：HPP 向所有有资格返回参加第三次临床检查的活跃 JHS 参与者开放 (n= 4644)。目标样本量是 24 个月的招募和入组期间的 375 名 JHS 参与者。从 JHS 队列的活跃成员中，有 503 人经过了 HPP 资格预筛选。超过 90% 的预筛选者暂时符合该研究的资格。经过 16 个月的入组期后，完成了 375 名入组目标，在招募的第二个月内，超过所需样本量的 25% (n= 97) 入组。结论：研究结果表明，观察性研究的参与者可以成功招募到 RCT 中。观察性研究为研究人员提供了设计临床试验时可能感兴趣的明确人群。这对于招募高风险、传统上代表性不足的人群进行非药理学临床试验特别有用，其中传统招募方法可能会延长入组时间并延长研究预算。
Objectives:Randomized controlled trials (RCT) often employ multiple recruitment methods to attract participants, however, special care must be taken to be inclusive of under-represented populations. We examine how recruiting from an existing observational study affected the recruitment of African Americans into a RCT that included yoga-based interventions. In particular, we report the recruitment success of The Effects of Health Promoting Programs (HPP) on Cardiovascular Disease Risk (NCT02019953), the first yoga-based clinical trial to focus only on African Americans.Design:To recruit participants, a multifaceted recruitment strategy was implemented exclusively in the Jackson Heart Study (JHS) cohort. The HPP recruited from the JHS cohort using direct mailings, signs and flyers placed around JHS study facilities, and through JHS annual follow-up interviews.Results:Enrollment into HPP was open to all active JHS participants that were eligible to return for the third clinic exam (n= 4644). The target sample size was 375 JHS participants over a 24 month recruitment and enrollment period. From the active members of the JHS cohort, 503 were pre-screened for eligibility in HPP. More than 90% of those pre-screened were provisionally eligible for the study. The enrollment goal of 375 was completed after a 16-month enrollment period with over 25% (n= 97) of the required sample size enrolling during the second month of recruitment.Conclusions:The findings show that participants in observational studies can be successfully recruited into RCT. Observational studies provide researchers with a well-defined population that may be of interest when designing clinical trials. This is particularly useful in the recruitment of a high-risk, traditionally underrepresented populations for non-pharmacological clinical trials where traditional recruitment methods may prolong enrollment periods and extend study budgets.