Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Prevention
Masking
Single (Participant)
Masking Description
Participants will be blinded to their study participation status, participants will not be asked to take any action to enroll in the study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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
  • Behavioral: ILI Predictive Alerts, Reactive Content, and Proactive Content
    Participants receive ILI-related education, feedback, and opportunities to self-monitor ILI symptoms, in addition they also receive alerts about potential ILI illness, and reactive and personalized content about protective health behaviors.
  • Behavioral: ILI Predictive Alerts, Reactive Content
    Participants receive alerts about potential ILI illness, and reactive and personalized content about protective health behaviors.
Experimental
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
  • Behavioral: ILI Predictive Alerts, Reactive Content
    Participants receive alerts about potential ILI illness, and reactive and personalized content about protective health behaviors.
Experimental
Proactive ILI content & No Predictions
Participants will not receive predictive alerts or reactive content after reporting symptoms but will receive proactive ILI content
  • Behavioral: Proactive Content
    Participants receive ILI-related education, feedback, and opportunities to self-monitor ILI symptoms.
  • Behavioral: No Intervention
    Participants will not receive predictive alerts or reactive content after reporting symptoms or proactive IILI-related health educational content
Experimental
No Proactive ILI content & No Predictions
Participants will not receive predictive alerts or reactive content after reporting symptoms or proactive ILI content
  • Behavioral: No Intervention
    Participants will not receive predictive alerts or reactive content after reporting symptoms or proactive IILI-related health educational content

Recruiting Locations

More Details

NCT ID
NCT06229444
Status
Active, not recruiting
Sponsor
Evidation Health

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.