Predict + Protect: A Randomized Controlled Trial Exploring the Effectiveness of a Predictive Health Education Intervention on the Adoption of Protective Behaviors Related to Influenza-like Illness (ILI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17,043
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to assess the effectiveness of a predictive ILI detection algorithm and associated alerts on ILI-related health and behavioral outcomes
研究概览
简要总结
The goal of this prospective, digital randomized controlled trial is to evaluate the effectiveness of a predictive ILI detection algorithm and associated alerts during influenza season for adults living in the contigent United States. The main study objectives are to assess the effectiveness of predictive ILI detection algorithm and associated alerts on protective behaviors related to ILI and assess the accuracy of a predictive ILI detection algorithm using participant self-reported ILI symptoms and diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to their study participation status, participants will not be asked to take any action to enroll in the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Member of the Evidation platform
- •18 years or older
- •Lives in the U.S.
- •Currently owns and uses a consumer wearable activity tracker (Apple Watch, Garmin, or Fitbit) linked to their Evidation account
- •Meets data density requirements for wearable data: Steps and heart rate data present for 15% of the last 60 days (or no fewer than 2 total days for Evidation accounts less than 60 days old)
排除标准
- •Does not have an Evidation account
- •Not 18 years or older
- •Does not live in the U.S.
- •Does not have an activity tracker linked to their Evidation account
- •Enrolled in an Evidation supported ILI monitoring and engagement program, or clinical study (e.g., FluSmart)
研究组 & 干预措施
Proactive ILI content & Predictions
Participants will receive predictive alerts, reactive content after reporting symptoms or receiving an asymptomatic prediction, and ILI-related health educational content
干预措施: ILI Predictive Alerts, Reactive Content, and Proactive Content (Behavioral)
No Proactive ILI content & Predictions
Participants will receive predictive alerts and reactive content after reporting symptoms or receiving an asymptomatic prediction, but will not receive proactive ILI content
干预措施: ILI Predictive Alerts, Reactive Content (Behavioral)
Proactive ILI content & No Predictions
Participants will not receive predictive alerts or reactive content after reporting symptoms but will receive proactive ILI content
干预措施: Proactive Content (Behavioral)
No Proactive ILI content & No Predictions
Participants will not receive predictive alerts or reactive content after reporting symptoms or proactive ILI content
干预措施: No Intervention (Behavioral)
结局指标
主要结局
The primary objective of this study is to assess the effectiveness of a predictive ILI detection algorithm and associated alerts on ILI-related health and behavioral outcomes
时间窗: Through study completion, approximately 10 months
The difference between the predictive alert and the no predictive alert groups in the proportion of cohort members who performed any target health behavior 1-4 (i.e. performed at least one of: reduced spread, tested, sought medical attention, or was treatment adherent)
次要结局
- The secondary objective is to assess the accuracy of an ILI detection algorithm using self-reported symptoms and ILI diagnosis(Through study completion, approximately 10 months)