NCT07741955

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for not_applicable

Timeline
64mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

4.3 years

First QC Date

July 13, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

VeteransClinical Trial RecruitmentCardiovascular DiseaseArtificial IntelligencePatient EngagementHealth LiteracyVirtual Outreach

Outcome Measures

Primary Outcomes (1)

  • Proportion of Veterans who enroll in the parent VA Cooperative Studies cardiovascular trial within 6 months of receiving the invitation

    Superiority of enrollment rate in the intervention arm (AI-supported avatar invitation) compared to the control arm (routine letter invitation alone), assessed using an intention-to-treat approach.

    Baseline through 6 months

Secondary Outcomes (3)

  • Proportion of Veterans accessing the intervention website

    Baseline through 6 months

  • Proportion of Veterans viewing avatar videos

    Baseline through 6 months

  • Avatar preferences

    Baseline through 6 months

Study Arms (2)

Control: Standard Mailed Letter Invitation

NO INTERVENTION

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: AI-Supported Virtual Outreach

EXPERIMENTAL

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.

Behavioral: AI-Generated Avatar Videos for Clinical Trial Outreach

Interventions

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.

Also known as: AI-Supported Patient Engagement Tool
Experimental: AI-Supported Virtual Outreach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran receiving care at VAPAHCS
  • Recently invited (within 3 months) to participate in an existing cardiovascular clinical trial at VAPAHCS
  • Able to provide informed consent in English
  • Veteran receiving care at VAPAHCS or a participating VA-CTC site
  • Able to view a brief video and complete a short survey in English
  • VA study coordinator or trial investigator actively engaged in cardiovascular clinical trial recruitment at VAPAHCS or a VA-CTC site
  • Willing to participate in a 60-90 minute virtual focus group

You may not qualify if:

  • Cognitive impairment documented in the electronic health record
  • Inability to communicate in English at a level sufficient for qualitative interview participation
  • Inability to communicate in English at a level sufficient for survey completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Atrial FibrillationCardiovascular DiseasesPatient Participation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Celina M. Yong, MD MBA MSc

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Vesom, MPH CCRP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in the control arm receive a standard mailed letter and are not aware of the avatar video intervention being received by the intervention arm. Study coordinators and investigators are aware of group assignment for operational purposes. Full blinding is not possible given the nature of the communication intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Veterans are randomized 1:1 to two concurrent arms with no crossover. The control arm receives a standard mailed letter invitation to the parent VA Cooperative Studies cardiovascular trial. The intervention arm receives the identical letter enhanced with a QR code and URL linking to AI-generated avatar videos and a chatbot, deployed across both the screening and treatment components of the parent trial. An adaptive design allows refinement of avatar options at pre-specified interim analyses without altering the parallel group structure or primary endpoint analysis.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2026

First Posted

August 3, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared externally. De-identified aggregate data will be disseminated through peer-reviewed publication and presentation at national cardiovascular conferences.

Locations