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招募青少年参与虚拟临床试验:Health4Me随机对照试验的招募结果

Recruitment of Adolescents to Virtual Clinical Trials: Recruitment Results From the Health4Me Randomized Controlled Trial.

作者信息

Raeside Rebecca, Todd Allyson R, Barakat Sarah, Rom Sean, Boulet Stephanie, Maguire Sarah, Williams Kathryn, Mihrshahi Seema, Hackett Maree L, Redfern Julie, Partridge Stephanie R

机构信息

Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, The University of Sydney, Western Avenue, Camperdown, 2050, Australia, 61 0468684450.

InsideOut Institute for Eating Disorders, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

出版信息

JMIR Pediatr Parent. 2024 Dec 16;7:e62919. doi: 10.2196/62919.

Abstract

BACKGROUND

Preventive interventions are needed to provide targeted health support to adolescents to improve health behaviors. Engaging adolescents in preventive interventions remains a challenge, highlighting the need for innovative recruitment strategies. Given adolescents' lives are intertwined with digital technologies, attention should be focused on these avenues for recruitment. The evolving nature of clinical trials, including the emergence of virtual clinical trials, requires new recruitment approaches, which must be evaluated.

OBJECTIVE

This study aimed to examine the effectiveness and cost of various digital recruitment strategies for recruiting adolescents to a virtual clinical trial, evaluate the progression of participants from screening to enrollment, and explore factors associated with nonparticipation. This was conducted using data from the Health4Me Study, a preventive digital health intervention to improve physical activity and nutrition behaviors among adolescents aged 12 to 18 years.

METHODS

Participants were recruited into the Health4Me Study via social media advertisements on various contemporary platforms, emails to schools, emails to contacts within known networks, and emails to relevant youth organizations. Data were collected from social media advertisements, screening, and recruitment logs. Data analysis included summary and descriptive statistics, as well as chi-square tests to explore factors associated with nonparticipation.

RESULTS

From 2369 expressions of interest, 390 (16.4%) participants were enrolled. A total of 19 advertisements were placed on social media, and 385 promotional emails were sent to schools, contacts within known networks, and relevant youth organizations. Social media advertisements reached 408,077 unique accounts. Advertisements mostly reached those living in populous states in Australia (306,489/408,077, 75.11% of unique accounts) and those identifying as female (177,698/408,077, 43.55% of unique accounts). A total of 24.97% (101,907/408,077) of advertisements were delivered to accounts with uncategorized genders. The total cost per participant enrolled was Aus $3.89 (approximately US $2.58). Most participants (1980/2305, 85.90%) found out about this study through Instagram. Differences in screening characteristics between eligible participants who did and did not enroll were found to be statistically significant for gender (P=.02), with fewer males and more individuals reporting their gender as "other" enrolling than expected by chance alone. The recruitment method also differed (P<.001), with fewer participants enrolling through Instagram and more enrolling through other methods (eg, known networks or word of mouth) than expected by chance alone.

CONCLUSIONS

This study found that virtual clinical trial recruitment was found to be low-cost, with the potential to increase trial participation. Social media was the most effective recruitment method, reaching all states and territories, including hard-to-reach populations. Future action is needed to explore recruitment methods that are more effective for males and to build trust among adolescents regarding clinical trial recruitment via social media.

摘要

背景

需要采取预防性干预措施,为青少年提供有针对性的健康支持,以改善健康行为。让青少年参与预防性干预仍然是一项挑战,这凸显了创新招募策略的必要性。鉴于青少年的生活与数字技术紧密相连,应将注意力集中在这些招募途径上。临床试验的不断发展,包括虚拟临床试验的出现,需要新的招募方法,且必须对其进行评估。

目的

本研究旨在检验各种数字招募策略在将青少年招募到虚拟临床试验中的有效性和成本,评估参与者从筛选到入组的进展情况,并探索与未参与相关的因素。这是利用健康4Me研究的数据进行的,该研究是一项预防性数字健康干预措施,旨在改善12至18岁青少年的身体活动和营养行为。

方法

通过在各种当代平台上投放社交媒体广告、向学校发送电子邮件、向已知网络中的联系人发送电子邮件以及向相关青年组织发送电子邮件,招募参与者加入健康4Me研究。从社交媒体广告、筛选和招募日志中收集数据。数据分析包括汇总和描述性统计,以及卡方检验,以探索与未参与相关的因素。

结果

在2369份感兴趣的表达中,有390名(16.4%)参与者入组。在社交媒体上共投放了19则广告,并向学校、已知网络中的联系人以及相关青年组织发送了385封宣传电子邮件。社交媒体广告覆盖了408,077个独立账户。广告主要覆盖了澳大利亚人口众多的州的居民(306,489/408,077,占独立账户的75.11%)以及女性(177,698/408,077,占独立账户的43.55%)。共有24.97%(101,907/408,077)的广告投放给了性别未分类的账户。每名入组参与者的总成本为3.89澳元(约合2.58美元)。大多数参与者(1980/2305,85.90%)是通过照片墙了解到这项研究的。在已入组和未入组的合格参与者的筛选特征方面,发现性别差异具有统计学意义(P = 0.02),入组的男性较少,报告性别为“其他”的个体比仅靠随机预期的要多。招募方式也存在差异(P < 0.001),通过照片墙入组的参与者较少,通过其他方式(如已知网络或口碑)入组的参与者比仅靠随机预期的要多。

结论

本研究发现,虚拟临床试验招募成本较低,有增加试验参与率的潜力。社交媒体是最有效的招募方法,覆盖了所有州和领地,包括难以接触到的人群。未来需要采取行动,探索对男性更有效的招募方法,并在青少年中建立对通过社交媒体进行临床试验招募的信任。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/269e/11683508/7d3c3d30bc64/pediatrics-v7-e62919-g001.jpg

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