Predict + Protect Study: Exploring the Effectiveness of a Predictive Health Education Intervention on the Adoption of Protective Behaviors Related to ILI

Evidation Health

Status: Invitation-only

Conditions: COVID-19; Influenza A; Respiratory Syncytial Virus (RSV); Influenza; Influenza B

Treatments: Behavioral: ILI Predictive Alerts, Reactive Content; Behavioral: Proactive Content; Behavioral: No Intervention; Behavioral: ILI Predictive Alerts, Reactive Content, and Proactive Content

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06229444

Predict + Protect Study

Details and patient eligibility

About

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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

15,000 participants in 4 patient groups

Proactive ILI content & Predictions

Experimental group

Description:

Participants will receive predictive alerts, reactive content after reporting symptoms or receiving an asymptomatic prediction, and ILI-related health educational content

Treatment:

Behavioral: ILI Predictive Alerts, Reactive Content, and Proactive Content

No Proactive ILI content & Predictions

Experimental group

Description:

Participants will receive predictive alerts and reactive content after reporting symptoms or receiving an asymptomatic prediction, but will not receive proactive ILI content

Treatment:

Behavioral: ILI Predictive Alerts, Reactive Content

Proactive ILI content & No Predictions

Experimental group

Description:

Participants will not receive predictive alerts or reactive content after reporting symptoms but will receive proactive ILI content

Treatment:

Behavioral: Proactive Content

No Proactive ILI content & No Predictions

Experimental group

Description:

Participants will not receive predictive alerts or reactive content after reporting symptoms or proactive ILI content

Treatment:

Behavioral: No Intervention