Health Ahead Comparative Effectiveness Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWilliam Brandenburg, MD

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • Interactive Personalized Health Report

    Behavioral

    Static versus interactive health report

  • Mobile Community-Based Health Screenings

    Behavioral

    Mobile versus Fixed Laboratory Health Screenings

  • Hybrid Medical Droid and Human Delivered Health Screenings

    Behavioral

    Hybrid Medical Droid and Human Delivered versus Human-Only Delivered Health Screenings

Treatment groups

1,000,000 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Static Personalized Health ReportActive comparator 1 intervention
Group B: Interactive Personalized Health ReportExperimental treatment 1 intervention
Group C: Fixed-Lab Health ScreeningsActive comparator 1 intervention
Group D: Mobile Lab Health ScreeningsExperimental treatment 1 intervention
Group E: Human Delivered Health ScreeningsActive comparator 1 intervention
Group F: Hybrid Medical Droid and Human Delivered Health ScreeningsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years.

Secondary outcomes

1

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.

Time frame
Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years.
2

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.

Time frame
Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years.
3

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).

Time frame
Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years.
4

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.

Time frame
Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

William Brandenburg, MD

Lead sponsor

Longevity Metrics, Inc.

Sponsor institution