The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each change is isolated as a single variable against current practice, and every comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, so results accumulate on a consistent yardstick across the life of the platform.
The first comparison evaluates AI-assisted versus human-only interpretation ("reads") of screening data. Subsequent pre-planned comparisons, added by protocol amendment, evaluate static versus interactive personalized report delivery; mobile community versus fixed laboratory screening; and a hybrid medical-droid-plus-human delivery model versus human-only screening.
Age 18 years or older
Willing and able to provide written informed consent, or enrollment with consent of a legally authorized representative
Willing to participate in longitudinal follow-up.
None
Parallel
AI-Assisted Screening Interpretation (AI Reads)
BehavioralAn AI-generated read of the acquired screening battery is produced and presented to the physician of record as a clinical aid. All models used are third-party models, executed unmodified on Longevity Metrics clinical infrastructure. The physician reviews each read, records a structured judgment before sign-off, and then produces and signs the released interpretation, which may adopt, modify, or reject any read.
Human-Only Screening Interpretation
BehavioralAll acquired screening data, images, tracings, and laboratory results are interpreted by the physician of record and qualified clinical staff under physician supervision, by standard practice and without AI decision support. This is the current standard of care and the active comparator.
Health Awareness and Action (Non-Inferiority)
Change from baseline in health awareness and action score, measured by the Health Awareness and Action 6-item questionnaire (HAA-6) or its successor instrument, specified and locked in the comparison's Statistical Analysis Plan before first allocation. Change is compared between the experimental arm and the active comparator arm. Non-inferiority is assessed with a one-sided test at the 6-12-month timepoint against a margin pre-specified in the comparison's Statistical Analysis Plan and locked before any analysis of comparison data.
Health Awareness and Action (Superiority)
Conditional on non-inferiority being established in the primary analysis, superiority of the experimental arm over the active comparator arm on change from baseline in health activation score is tested within a pre-specified hierarchical (gatekeeping) sequence, on the same contrasts as the primary analysis, and reported whenever the data support a superiority claim.
Report Efficacy and Utilization
Participant-reported efficacy and utilization of the personalized report, compared between arms, using two items each rated 1-10: (a) "This report helped me understand my health better"; (b) "This report helped me understand what to do to improve my health". Items (a) and (b) are compared across arms.
Unintended Consequences and Psychological Impact
Participant-reported emotional response to receiving personalized risk estimates (estimated biological age, predicted age at death, and predicted causes of death), compared between arms, rated on three bipolar 1-10 scales: anxious or overwhelmed (1) to empowered (10); distressed (1) to motivated (10); and confused (1) to informed (10).
Completion of Provider-Recommended Health Behavior Changes
On the personalized screening report, the provider specifies the three highest-priority recommended changes, spanning lifestyle, environmental, and medical domains. At each follow-up, participants report for each of the three whether they completed or adhered to it. The primary metric is the number of provider-recommended changes completed (0-3), compared between arms.
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William Brandenburg, MD
Lead sponsor
Longevity Metrics, Inc.
Sponsor institution
