Empowering Veterans in Research Effectively Using Virtual Engagement Tools

Part of paid clinical trials in Palo Alto, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07741955
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)
  • Cardiovascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • AI-Generated Avatar Videos for Clinical Trial Outreach — BEHAVIORAL
    Veterans randomized to the intervention arm will receive the website link where they can select their preferred avatar speaker(s) from a diverse set of options and self-select content topics of interest. They may watch the self-directed tailored video to guide their decision to participate in the parent trial.

Study Details

Cardiovascular disease is the leading cause of death among Veterans. Clinical trials are essential for developing better treatments, but Veterans remain underrepresented in these studies due to barriers including limited health literacy, lack of awareness, and mistrust. Current outreach approaches rely on either in-person physician conversations, which are limited by workforce constraints, or mailed letter invitations, which often fail to engage Veterans with limited health literacy. This study tests whether AI-generated video avatars can improve Veteran engagement in cardiovascular clinical trials.

Key Dates

First listed
Aug 3, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
100,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Control: Standard Mailed Letter Invitation
    Veterans randomized to the control arm receive the standard mailed letter invitation to the parent VA Cooperative Studies cardiovascular trial, which represents current standard of care for large-scale VA cardiovascular trial outreach.
  • Experimental: Experimental: AI-Supported Virtual Outreach
    Veterans randomized to the intervention arm receive the standard mailed letter invitation enhanced with a QR code and URL linking to a website hosting AI-generated avatar videos. Veterans may select their preferred avatar speaker from a diverse set of options and self-select content topics of interest. QR codes are deployed for both the screening and treatment components of the parent cardiovascular trial.

Primary Outcome Measure

Proportion of Veterans who enroll in the parent VA Cooperative Studies cardiovascular trial within 6 months of receiving the invitation [ Time Frame: Baseline through 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Nicholas Vesom, MPH CCRP
[email protected]
(650) 493-5000
Celina M. Yong, MD MBA MSc (PRINCIPAL_INVESTIGATOR)
Paul A. Heidenreich, MD MS (SUB_INVESTIGATOR)

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VA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CA

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