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| ID | Type | Description | Link |
|---|---|---|---|
| IORG0012336; IRB0001460 | Other Identifier | OHRP |
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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.
Access to comprehensive preventive health screening is profoundly unequal. Geographic, economic, and systemic barriers leave medically underserved populations - including rural, frontier, and isolated communities - with little or no access to the depth of preventive screening that identifies disease before symptoms occur. The long-term aim of this work is a fully automated preventive screening system that can be deployed anywhere people live. Reaching that aim safely and credibly requires testing each change to the screening model one variable at a time, against current practice.
The Health Ahead Comparative Effectiveness Study is therefore designed as a standing sequential comparative-effectiveness platform. Each phase is a parallel two-arm comparison that isolates a single change while holding all other elements of the screening experience constant, and each is evaluated with the same core outcome set. As one comparison concludes, the next is opened by protocol amendment. Throughout, all participants are concurrently enrolled in the 100-Year Human Aging Study and the Human Observatory Study, so that short-horizon comparative findings are linked to lifelong individual and population-level outcomes.
Two design principles govern every comparison. First, allocation is randomized wherever randomization is feasible and non-randomized only where participant-level random assignment is not possible (for example, comparisons of screening location such as mobile versus fixed laboratory). Second, every comparison is registered with non-inferiority as the primary hypothesis: each evolutionary change toward a more automated and more broadly deployable model must demonstrate that it does not degrade outcomes relative to current practice, by more than a pre-specified margin. The unifying thesis is that quality is preserved as the platform evolves. Superiority is assessed as a pre-specified secondary in a hierarchical (gatekeeping) test and reported whenever non-inferiority is established and the data support a superiority claim. The same core outcome set is applied to every comparison to the greatest extent each comparison allows.
The planned comparison sequence is:
The platform launches in Colorado, chosen as the founding geography for its exceptional diversity of medically underserved communities - high-altitude frontier towns, rural agricultural communities, mining corridors, and isolated mountain communities - within a well-characterized geography with established academic research infrastructure. Findings are designed to generalize to medically underserved populations nationally, internationally, and to inform federal health policy on mobile and automated preventive health delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Static Personalized Health Report | Active Comparator | Participants complete comprehensive multi-system health screening and receive a standard static personalized health report. |
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| Interactive Personalized Health Report | Experimental | Participants complete identical comprehensive multi-system health screening and receive an interactive personalized report allowing real-time adjustment of behaviors and diagnostic inputs to visualize projected changes in composite scores, estimated biological age, and aging trajectory. |
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| Fixed-Lab Health Screenings | Active Comparator | Health screenings performed at fixed-lab site. |
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| Mobile Lab Health Screenings | Experimental | Health screenings performed in remote locations using a mobile lab |
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| Human Delivered Health Screenings | Active Comparator | Health screenings delivered by human operators only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive Personalized Health Report | Behavioral | Static versus interactive health report |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
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Inclusion Criteria:
Exclusion Criteria:
- Age under 18 years.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Brandenburg, MD | Contact | 13035010016 | info@longevitymetrics.org |
| Name | Affiliation | Role |
|---|---|---|
| William Brandenburg, MD | Longevity Metrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longevity Metrics | Recruiting | Boulder | Colorado | 80301 | United States |
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This is a multi-domain comparative-effectiveness platform study of how health screening is delivered. Each domain compares two conditions: (1) Report format - static vs. interactive personalized health report; (2) Screening setting - fixed-site vs. mobile community-based screening; (3) Delivery model - human-delivered vs. hybrid medical-droid-and-human-delivered screening. Domains open over the course of the study and additional domains may be added by amendment. A participant may receive interventions from more than one domain. Allocation is randomized within a domain whenever operationally feasible (e.g., report format) and otherwise follows setting and availability (e.g., screening setting determined by location and participant presentation). Allocation procedures for the delivery-model domain will be finalized by protocol amendment.
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| Hybrid Medical Droid and Human Delivered Health Screenings | Experimental | Health screenings delivered by a hybrid model using medical droid and human operators |
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| Mobile Community-Based Health Screenings | Behavioral | Mobile versus Fixed Laboratory Health Screenings |
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| Hybrid Medical Droid and Human Delivered Health Screenings | Behavioral | Hybrid Medical Droid and Human Delivered versus Human-Only Delivered Health Screenings |
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| 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. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| 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). | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| 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. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Primary Barrier to Non-Completion of Recommended Changes | For each provider-recommended change a participant reports not completing, the participant identifies the single main barrier using a fixed-choice item adapted to that recommendation ("What is the main thing getting in the way of [recommendation]?"). Response options: Time; Money or cost; Access to care or services; Stress or mental health; Sleep; Addiction or substance use; Physical limitations, pain, or symptoms; Knowledge (not sure what to do); Motivation; Habits or routines; Family or relationship demands; Other (free text). The metric is the distribution of selected barriers across non-completed recommendations, compared between arms. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Participant Satisfaction - Longevity Metrics Post-Screening Satisfaction Questionnaire (6-item), Composite Score | Participant satisfaction measured with the Longevity Metrics Post-Screening Satisfaction Questionnaire, a 6-item self-report instrument administered after the participant receives their screening report. Each item is rated on a 1-10 linear scale; items cover perceived value of the report, satisfaction with the tester, the screening, and the data/report/recommendations, and likelihood to recommend Longevity Metrics. A composite score is calculated as the sum of all items (minimum 6, maximum 60); higher scores indicate greater satisfaction. Compared between groups. | 1 to 2 weeks after health screening (at report delivery) |
| Complexity-Adjusted Cost-Effectiveness | Complexity-adjusted cost, computed as total direct costs ÷ (screening complexity weight × participants completing screening), where the complexity weight reflects the scope and intensity of the screening battery delivered (e.g., single-modality DEXA versus the full multi-system report-card battery), so that a simpler, lower-cost screen is not credited as artificially more efficient than a broader battery that delivers more. An incremental cost-effectiveness ratio compares complexity-adjusted cost against improvement in the primary endpoint. | 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Participant Follow-up and Retention | Retention and follow-up completion across the lifelong cohort, compared between arms, assessed by: study retention (proportion of enrolled participants remaining active versus withdrawn or lost to follow-up); follow-up questionnaire completion (proportion completing each scheduled follow-up survey); and in-person re-screening return (proportion returning to the laboratory or mobile site for scheduled repeat testing). Initial follow-up occurs at 6-12 months; follow-up continues for life thereafter, enabling longitudinal ascertainment of chronic disease, adverse health outcomes, and mortality. Differential retention between arms is monitored as a potential source of bias in non-inferiority comparisons. | 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Longitudinal Health Outcomes and Mortality | All-cause mortality, cause-specific mortality, incident serious health events, and incident chronic disease development, compared between arms as follow-up accumulates through the 100-Year Human Aging Study protocol. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Operational Throughput and Screening Completion | Operational equivalence across arms, assessed by: capacity utilization (time slots filled ÷ total available time slots); no-show rate (proportion of scheduled appointments not attended); and screening completion status (proportion of screenings fully completed, partially completed, or unable to be performed, with reason for non-completion recorded as patient declined, equipment failure, operator failure, or other [free text]). Compared between arms. | 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Data Quality and Test Validity | Objective data quality and test validity across arms, reported as the proportion of assessments meeting pre-specified quality thresholds, across three categories: (a) CPET test validity - proportion of cardiopulmonary exercise tests with peak respiratory exchange ratio (RER) at or above a pre-specified threshold (>~1.10); (b) instrument calibration - proportion of screening sessions in which the CPET metabolic cart, spirometer (PFT), and DEXA passed calibration/QC within manufacturer-specified thresholds; and (c) effort adequacy - proportion of effort-dependent tests for which provider-rated effort met or exceeded a pre-specified adequacy cutoff (e.g., ≥7 of 10). Compared between arms. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Population Characterization by Arm | Baseline characterization by arm across sociodemographic, geographic, environmental, health history and healthcare utilization domains. Functions as a randomization-balance check where assignment is randomized, and as a substantive between-population comparison where arms draw from different settings (Comparison 2 onward). | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Screening-Related Adverse Events | Participant-reported adverse events attributed to the screening, captured after each screening visit by a single mark-all-that-apply item: "Did you experience any of the following as a result of your health screening?" Options: musculoskeletal injury; other injury; a fall; dizziness, lightheadedness, or fainting; chest pain or palpitations; shortness of breath; excessive muscle soreness or fatigue; bruising, bleeding, or pain at the blood draw site; pain or discomfort during a test; distress; anxiety; confusion; feeling overwhelmed; trouble sleeping; none; other adverse health event (free text). The metric is the proportion of participants reporting each event category, compared between arms; events are also captured in the trial's standard adverse-event reporting. | Baseline, 6-12-month follow-up, then periodically from enrollment until death, up to 100 years. |
| Change in peak oxygen uptake (VO2peak) measured by cardiopulmonary exercise testing | VO2peak is the highest rate of oxygen consumption achieved during a symptom-limited cardiopulmonary exercise test (CPET), expressed in mL/kg/min. Higher values indicate greater cardiorespiratory fitness. Change is calculated as the difference between successive screenings (follow-up minus baseline) and compared between arms. Unit of Measure: mL/kg/min | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in heart rate recovery at 2 minutes post-exercise | Heart rate recovery (HRR) at 2 minutes is the difference between peak heart rate at the end of cardiopulmonary exercise testing and the heart rate measured 2 minutes into recovery, expressed in beats per minute (bpm). A larger drop indicates better autonomic function. Change is the difference between successive screenings, compared between arms. Unit of Measure: bpm | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in maximal handgrip strength by hand dynamometer | Maximal handgrip strength measured with a hand dynamometer, recorded as the single highest value obtained across 2-3 trials in either hand, expressed in kilograms (kg). Higher values indicate greater strength. Change is the difference between successive screenings, compared between arms. Unit of Measure: kg | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in Sit-to-Rise score | The Sit-to-Rise Test assesses lower-body strength, mobility, flexibility, and balance by requiring the participant to sit on and rise from the floor with minimal support. Scored 0-5 for sitting and 0-5 for rising, summed to a 0-10 composite; higher scores indicate better musculoskeletal function. Change is the difference between successive screenings, compared between arms. Unit of Measure: Units on a scale (0-10) | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in appendicular lean mass index (ALMI) by DEXA | Appendicular lean mass index is the sum of lean soft-tissue mass in the arms and legs measured by dual-energy X-ray absorptiometry (DXA), divided by height squared, expressed in kg/m². Higher values indicate greater skeletal muscle mass. Change is the difference between successive screenings, compared between arms. Unit of Measure: kg/m² | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in visceral adipose tissue (VAT) mass by DEXA | Visceral adipose tissue mass estimated by dual-energy X-ray absorptiometry (DXA), expressed in grams (g). Lower values indicate less visceral fat. Change is the difference between successive screenings, compared between arms. Unit of Measure: grams | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in fasting serum triglycerides | Fasting serum triglyceride concentration measured by a CLIA-certified reference laboratory, expressed in mg/dL. Lower values indicate a more favorable lipid profile. Change is the difference between successive screenings, compared between arms. Unit of Measure: mg/dL | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in 2-hour post-load glucose during oral glucose tolerance test, measured by continuous glucose monitor | Glucose measured 120 minutes after a 75 g oral glucose load (OGTT) using a continuous glucose monitor (CGM), expressed in mg/dL. Lower values indicate better post-load glucose disposal. Change is calculated as the difference between successive screenings, compared between arms. Unit of Measure: mg/dL | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in resting mean arterial pressure (MAP) | Resting mean arterial pressure derived from resting brachial systolic (SBP) and diastolic (DBP) blood pressure using MAP = (2 × DBP + SBP) / 3, expressed in mmHg; a single value is reported per assessment. Change is the difference between successive screenings, compared between arms. Unit of Measure: mmHg | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| Change in number of patient-reported symptoms (Longevity Metrics symptom checklist) | Symptom burden via the Longevity Metrics 24-item self-report checklist; participants mark all that apply: (1) chest pain or pressure; (2) shortness of breath on minimal/moderate exertion; (3) dizziness or fainting; (4) fever or night sweats; (5) fatigue; (6) erectile dysfunction; (7) persistent cough; (8) coughing up blood; (9) difficulty swallowing; (10) unexplained weight loss; (11) excessive thirst/urination; (12) abdominal pain; (13) nausea or vomiting; (14) diarrhea; (15) constipation; (16) blood in stool or urine; (17) headaches; (18) weakness or numbness; (19) vision changes; (20) memory problems; (21) new lump or swelling; (22) non-healing wound or sore; (23) skin rash; (24) a fall from loss of balance, dizziness, or weakness in the last 6 months (not during sports/recreation). Each item and "Other" score 1; "None of the above" scores 0. Change is the difference between successive screenings, compared between arms. Unit of measure: number of symptoms marked | Baseline, 6-12 months, then periodically through study completion (up to 100 years) |
| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D015438 | Health Behavior |
| D002318 | Cardiovascular Diseases |
| D024821 | Metabolic Syndrome |
| D060825 | Cognitive Dysfunction |
| D000073496 | Frailty |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D001519 | Behavior |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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