Health Ahead Comparative Effectiveness Study

NCT07669168 | Recruiting

• 2 other identifiers: HealthAheadCEIORG0012336; IRB00014601
• Study Type: interventional
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Services Accessibility; Rural Health; Medically Underserved Area; Preventive Health Services; Patient Participation; Health Behavior; Aging; Cardiovascular Diseases; Metabolic Syndrome; Cognitive Dysfunction; Frailty; Activities of Daily Living; Health Related Quality of Life; Health Equity; Telemedicine

Keywords

Sequential Platform Trial; Interactive Health Report; Health Activation; Mobile Health Screening; Comparative Effectiveness; Health Equity; Rural Health; Medically Underserved; Preventive Medicine; Patient Engagement; Cardiopulmonary Exercise Testing; Body Composition; DEXA; Health Ahead Bus; Mobile Clinic; Automated Screening; Medical Droids; Biological Age; Healthspan; Longevity; Life Expectancy; Chronic Disease; Cost-Effectiveness; Health Services Research; Artificial Intelligence; Clinical Decision Support; Diagnostic Interpretation; Machine Learning

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (29)

• Health Awareness and Action (Superiority)

  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.

• Report Efficacy and Utilization

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

• Unintended Consequences and Psychological Impact

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

• Completion of Provider-Recommended Health Behavior Changes

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

• Primary Barrier to Non-Completion of Recommended Changes

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

Study Arms (2)

Human-Only Screening Interpretation

ACTIVE COMPARATOR

Participants receive comprehensive preventive health screening under the standard of care for the comparison in progress. In the active comparison, all screening data, images, tracings, and laboratory results are interpreted by the physician of record and qualified clinical staff under physician supervision, without AI decision support.

Behavioral: Human-Only Screening Interpretation

AI-Assisted Screening Interpretation (AI Reads)

EXPERIMENTAL

Participants receive identical screening with one element modified: the single variable under test in the comparison in progress. In the active comparison, models produce AI-generated reads of the acquired data, presented to the physician of record as a clinical aid. The physician reviews each read, records a structured judgment before sign-off, and produces and signs the released interpretation. The comparison runs in two screening-complexity strata, with a single general model in the simple stratum and a general model plus at least three domain-specific models in the comprehensive stratum.

Behavioral: AI-Assisted Screening Interpretation (AI Reads)

Interventions

Human-Only Screening Interpretation BEHAVIORAL

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.

Human-Only Screening Interpretation

AI-Assisted Screening Interpretation (AI Reads) BEHAVIORAL

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.

AI-Assisted Screening Interpretation (AI Reads)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Age under 18 years.

Sponsors & Collaborators

• William Brandenburg, MD: lead

Study Sites (1)

Longevity Metrics

Boulder, Colorado, 80301, United States

RECRUITING

Related Links

• Longevity Metrics Research

MeSH Terms

Conditions

Patient Participation; Health Behavior; Cardiovascular Diseases; Metabolic Syndrome; Cognitive Dysfunction; Frailty; Chronic Disease

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• William Brandenburg, MD

  Longevity Metrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Brandenburg, MD

CONTACT

13035010016; info@longevitymetrics.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a pragmatic, sequential comparative-effectiveness platform study of how preventive health screening is delivered. Each comparison isolates a single change to the screening model against current practice, holds every other element constant, and is evaluated on a common core outcome set, with non-inferiority as the primary hypothesis. Comparisons activate sequentially by protocol amendment; each is a parallel-arm comparison, and the arms registered on this record reflect the active comparison. Comparison 1 (active) - AI-assisted versus human-only interpretation ("reads") of screening data. Both arms complete identical screening and differ only in whether the acquired data receive an AI-generated read; a physician of record reviews and signs every released interpretation in both arms. Allocation is randomized 1:1 within two strata defined by screening complexity.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 25, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)