Clinical trial NCT06229444: Predict + Protect Study: Exploring the Effectiveness of a Predictive Health Education Intervention on the Adoption of Protective Behaviors Related to ILI
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Influenza A
Influenza B
COVID-19
Respiratory Syncytial Virus (RSV)
Keywords: Flu
Influenza
RSV
COVID
Wearable
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2024-01-29
Enrollment: 17043
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Through study completion, approximately 10 months
Secondary outcomes:
measure: The secondary objective is to assess the accuracy of an ILI detection algorithm using self-reported symptoms and ILI diagnosis
timeFrame: Through study completion, approximately 10 months
Other outcomes:
measure: The exploratory objective is to assess differences in effectiveness between the four groups on ILI-related health and behavioral outcomes
timeFrame: Through study completion, approximately 10 months
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
affiliation: Evidation
name: Ernesto H.N. Ramirez, PhD
role: PRINCIPAL_INVESTIGATOR
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