Health Ahead Comparative Effectiveness Study

Condition(s) studied

Investigational drug(s) / intervention(s)

AI-Assisted Screening Interpretation (AI Reads): An 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: All 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Health Awareness and Action (Non-Inferiority) — Baseline (intake, completed at home before the screening visit); 1-2 weeks after screening, at report delivery; 6-12-month follow-up; then periodically from enrollment until death, up to 100 years.
  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.

Trial sites (1)

Other trials for the same condition