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

August 27, 2024 updated by: Evidation Health

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94402
        • Evidation Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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)
Through study completion, approximately 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary objective is to assess the accuracy of an ILI detection algorithm using self-reported symptoms and ILI diagnosis
Time Frame: Through study completion, approximately 10 months
Evaluate algorithm performance (against labels from self-reported ILI symptoms and/or self-reported positive diagnosis) overall and per model deployed. Algorithm performance will be assessed across a variety of dimensions including ROC AUC, sensitivity, specificity, PPV, and NPV
Through study completion, approximately 10 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The exploratory objective is to assess differences in effectiveness between the four groups on ILI-related health and behavioral outcomes
Time Frame: Through study completion, approximately 10 months
The difference between all 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)
Through study completion, approximately 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

Biomedical Advanced Research and Development Authority

Investigators

  • Principal Investigator: Ernesto H.N. Ramirez, PhD, Evidation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Actual)

August 5, 2024

Study Completion (Estimated)

September 6, 2024

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Predict + Protect Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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