About this trial
The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform.
The first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Factorial
Treatments tested in this trial
Interactive Personalized Health Report
BehavioralStatic versus interactive health report
Mobile Community-Based Health Screenings
BehavioralMobile versus Fixed Laboratory Health Screenings
Hybrid Medical Droid and Human Delivered Health Screenings
BehavioralHybrid Medical Droid and Human Delivered versus Human-Only Delivered Health Screenings
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Health Activation and Engagement (Non-Inferiority)
Change from baseline in health activation score, measured by a validated open-source instrument, compared between the static report arm (Arm A) and the interactive report arm (Arm B). Non-inferiority of the interactive arm is assessed with a one-sided non-inferiority test against a non-inferiority margin pre-specified in the comparison's Statistical Analysis Plan and locked before any analysis of comparison data.
Secondary outcomes
Health Activation and Engagement (Superiority)
Conditional on non-inferiority being established in the primary analysis, superiority of the interactive arm (Arm B) over the static arm (Arm A) on change from baseline in health activation score is tested within a pre-specified hierarchical (gatekeeping) sequence, 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 three 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"; and (c) "I utilized the interactive features on this report" (interactive arm only). 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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
William Brandenburg, MD
Lead sponsor
Longevity Metrics, Inc.
Sponsor institution