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

E

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

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Joyce HN Nortey, MPH, MSBH; Ernesto Ramirez, PhD

Data sourced from clinicaltrials.gov

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