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Completed

NCT Number: NCT06229444

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

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Key information

Conditions

Influenza COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza A Influenza B Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Syncytial Virus (RSV) Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evidation Health

San Mateo, California, 94402, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ILI Predictive Alerts, Reactive Content, and Proactive Content

Behavioral

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.

ILI Predictive Alerts, Reactive Content

Behavioral

Participants receive alerts about potential ILI illness, and reactive and personalized content about protective health behaviors.

Proactive Content

Behavioral

Participants receive ILI-related education, feedback, and opportunities to self-monitor ILI symptoms.

No intervention

Behavioral

Participants will not receive predictive alerts or reactive content after reporting symptoms or proactive IILI-related health educational content

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Evidation Health

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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