Baca-Motes Katie, Edwards Alison M, Waalen Jill, Edmonds Shawn, Mehta Rajesh R, Ariniello Lauren, Ebner Gail S, Talantov Dimitri, Fastenau John M, Carter Chureen T, Sarich Troy C, Felicione Elise, Topol Eric J, Steinhubl Steven R
Scripps Research Translational Institute, 3344 N Torrey Pines Ct, Plaza Level, La Jolla, CA, 92037, USA.
Wave Research Center, 8330 W Third St, Los Angeles, CA, 90048, USA.
Contemp Clin Trials Commun. 2019 Jan 7;14:100318. doi: 10.1016/j.conctc.2019.100318. eCollection 2019 Jun.
The advent of large databases, wearable technology, and novel communications methods has the potential to expand the pool of candidate research participants and offer them the flexibility and convenience of participating in remote research. However, reports of their effectiveness are sparse. We assessed the use of various forms of outreach within a nationwide randomized clinical trial being conducted entirely by remote means.
Candidate participants at possibly higher risk for atrial fibrillation were identified by means of a large insurance claims database and invited to participate in the study by their insurance provider. Enrolled participants were randomly assigned to one of two groups testing a wearable sensor device for detection of the arrhythmia.
Over 10 months, the various outreach methods used resulted in enrollment of 2659 participants meeting eligibility criteria. Starting with a baseline enrollment rate of 0.8% in response to an email invitation, the recruitment campaign was iteratively optimized to ultimately include website changes and the use of a five-step outreach process (three short, personalized emails and two direct mailers) that highlighted the appeal of new technology used in the study, resulting in an enrollment rate of 9.4%. Messaging that highlighted access to new technology outperformed both appeals to altruism and appeals that highlighted accessing personal health information.
Targeted outreach, enrollment, and management of large remote clinical trials is feasible and can be improved with an iterative approach, although more work is needed to learn how to best recruit and retain potential research participants.
Clinicaltrials.govNCT02506244. Registered 23 July 2015.
大型数据库、可穿戴技术和新型通信方法的出现，有可能扩大候选研究参与者的范围，并为他们提供参与远程研究的灵活性和便利性。然而，关于其有效性的报道却很少。我们在一项完全通过远程方式进行的全国性随机临床试验中，评估了各种形式的宣传推广方法的使用情况。
通过一个大型保险理赔数据库识别出可能患心房颤动风险较高的候选参与者，并由其保险提供商邀请他们参与研究。已登记的参与者被随机分配到两组中的一组，测试一种用于检测心律失常的可穿戴传感器设备。
在10个多月的时间里，所使用的各种宣传推广方法使2659名符合资格标准的参与者入组。从对电子邮件邀请的0.8%的基线入组率开始，招募活动经过反复优化，最终包括网站更改和使用五步宣传流程（三封简短的个性化电子邮件和两封直邮信件），突出了研究中使用的新技术的吸引力，从而使入组率达到了9.4%。强调获得新技术的信息传递方式比单纯呼吁利他主义以及强调获取个人健康信息的方式更有效。
大型远程临床试验的有针对性的宣传推广、入组和管理是可行的，并且可以通过迭代方法加以改进，不过还需要开展更多工作来了解如何最好地招募和留住潜在的研究参与者。
Clinicaltrials.govNCT02506244。2015年7月23日注册。
