COVID-19, Influenza, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV)
Conditions
Keywords
Flu, Influenza, RSV, COVID, Wearable
Brief summary
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.
Interventions
BEHAVIORALILI 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.
BEHAVIORALILI Predictive Alerts, Reactive Content
Participants receive alerts about potential ILI illness, and reactive and personalized content about protective health behaviors.
BEHAVIORALProactive Content
Participants receive ILI-related education, feedback, and opportunities to self-monitor ILI symptoms.
BEHAVIORALNo Intervention
Participants will not receive predictive alerts or reactive content after reporting symptoms or proactive IILI-related health educational content
Sponsors
Biomedical Advanced Research and Development Authority
Evidation Health
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| The secondary objective is to assess the accuracy of an ILI detection algorithm using self-reported symptoms and ILI diagnosis | 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
| Measure | Time frame | Description |
|---|---|---|
| The exploratory objective is to assess differences in effectiveness between the four groups on ILI-related health and behavioral outcomes | 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) |
Countries
United States
Outcome results
None listed