Miller Hailey N, Voils Corrine I, Cronin Kate A, Jeanes Elizabeth, Hawley Jeffrey, Porter Laura S, Adler Rachel R, Sharp Whitney, Pabich Samantha, Gavin Kara L, Lewis Megan A, Johnson Heather M, Yancy William S, Gray Kristen E, Shaw Ryan J
School of Nursing, Duke University, North Carolina, NC, United States.
Duke Global Digital Health Science Center, Duke University, Durham, NC, United States.
JMIR Form Res. 2022 Sep 6;6(9):e38262. doi: 10.2196/38262.
The use of digital technologies and software allows for new opportunities to communicate and engage with research participants over time. When software is coupled with automation, we can engage with research participants in a reliable and affordable manner. Research Electronic Data Capture (REDCap), a browser-based software, has the capability to send automated text messages. This feature can be used to automate delivery of tailored intervention content to research participants in interventions, offering the potential to reduce costs and improve accessibility and scalability.
This study aimed to describe the development and use of 2 REDCap databases to deliver automated intervention content and communication to index participants and their partners (dyads) in a 2-arm, 24-month weight management trial, Partner2Lose.
Partner2Lose randomized individuals with overweight or obesity and cohabitating with a partner to a weight management intervention alone or with their partner. Two databases were developed to correspond to 2 study phases: one for weight loss initiation and one for weight loss maintenance and reminders. The weight loss initiation database was programmed to send participants (in both arms) and their partners (partner-assisted arm) tailored text messages during months 1-6 of the intervention to reinforce class content and support goal achievement. The weight maintenance and reminder database was programmed to send maintenance-related text messages to each participant (both arms) and their partners (partner-assisted arm) during months 7-18. It was also programmed to send text messages to all participants and partners over the course of the 24-month trial to remind them of group classes, dietary recall and physical activity tracking for assessments, and measurement visits. All text messages were delivered via Twilio and were unidirectional.
Five cohorts, comprising 231 couples, were consented and randomized in the Partner2Lose trial. The databases will send 53,518 automated, tailored text messages during the trial, significantly reducing the need for staff to send and manage intervention content over 24 months. The cost of text messaging will be approximately US $450. Thus far, there is a 0.004% known error rate in text message delivery.
Our trial automated the delivery of tailored intervention content and communication using REDCap. The approach described provides a framework that can be used in future behavioral health interventions to create an accessible, reliable, and affordable method for intervention delivery and engagement that requires minimal trial-specific resources and personnel time.
ClinicalTrials.gov NCT03801174; https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174.
数字技术和软件的使用为长期与研究参与者进行沟通和互动带来了新机遇。当软件与自动化相结合时，我们能够以可靠且经济的方式与研究参与者互动。研究电子数据采集（REDCap）是一款基于浏览器的软件，具备发送自动文本信息的功能。这一特性可用于在干预措施中向研究参与者自动发送量身定制的干预内容，具有降低成本、提高可及性和可扩展性的潜力。
本研究旨在描述在一项双臂、为期24个月的体重管理试验“Partner2Lose”中，开发并使用两个REDCap数据库，向指标参与者及其伴侣（二元组）提供自动干预内容和通信。
“Partner2Lose”将超重或肥胖且与伴侣同居的个体随机分为单独接受体重管理干预或与伴侣一起接受干预。开发了两个数据库以对应两个研究阶段：一个用于减肥启动阶段，一个用于减肥维持和提醒阶段。减肥启动数据库被编程为在干预的第1至6个月向参与者（双臂组）及其伴侣（伴侣辅助组）发送量身定制的文本信息，以强化课程内容并支持目标达成。体重维持和提醒数据库被编程为在第7至18个月向每个参与者（双臂组）及其伴侣（伴侣辅助组）发送与维持相关的文本信息。它还被编程为在为期24个月的试验过程中向所有参与者和伴侣发送文本信息，提醒他们参加小组课程、进行饮食回忆和身体活动跟踪以进行评估以及测量访问。所有文本信息均通过Twilio发送，且为单向发送。
在“Partner2Lose”试验中，5个队列（共231对夫妇）同意参与并被随机分组。在试验期间，数据库将发送53518条自动定制的文本信息，显著减少了工作人员在24个月内发送和管理干预内容的需求。短信费用约为450美元。到目前为止，短信发送的已知错误率为0.004%。
我们的试验使用REDCap实现了量身定制的干预内容和通信的自动化交付。所描述的方法提供了一个框架，可用于未来的行为健康干预，以创建一种可及、可靠且经济的干预交付和参与方法，所需的特定试验资源和人员时间最少。
ClinicalTrials.gov NCT03801174；https://clinicaltrials.gov/ct2/show/NCT03801174?term=NCT03801174
