Empowering Veterans in Research Effectively Using Virtual Engagement Tools

NCT07741955 | Not Yet Recruiting

• 1 other identifier: 87024
• Study Type: interventional
• Target: 100,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF); Cardiovascular Diseases

Keywords

Veterans; Clinical Trial Recruitment; Cardiovascular Disease; Artificial Intelligence; Patient Engagement; Health Literacy; Virtual 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 Veteran 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 and Chatbot for Clinical Trial Outreach

Interventions

AI-Generated Avatar Videos and Chatbot for Clinical Trial Outreach BEHAVIORAL

Veterans randomized to the intervention arm will receive the website link where they can select their preferred Veteran avatar speaker 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

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

You may qualify if:

• Age 65 years or older
• CHA2DS2-VASc Score of 3 or greater
• Veteran receiving care within the VA Health Care System
• Eligible to receive a mailed invitation through the parent VA Cooperative Studies cardiovascular trial recruitment process

You may not qualify if:

• Documented preference to opt out of VA research mailings
• Age 18 years or older
• 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
• Cognitive impairment documented in the electronic health record
• Inability to communicate in English at a level sufficient for qualitative interview participation
• Age 18 years or older
• Veteran receiving care at VAPAHCS or a participating VA-CTC site
• Able to view a brief video and complete a short survey in English
• \- Inability to communicate in English at a level sufficient for survey completion
• 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

Sponsors & Collaborators

• Stanford University: lead
• Palo Alto Veterans Institute for Research: collaborator
• VA Palo Alto Health Care System: collaborator

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Patient Participation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Celina Yong, MD, MBA, MSc

  Stanford University

  PRINCIPAL INVESTIGATOR

• Paul Heidenreich, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Vesom, MPH, CCRP

CONTACT

(650) 493-5000; nvesom@pavir.org

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share