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Not yet recruiting NCT07741955

Empowering Veterans in Research Effectively Using Virtual Engagement Tools

No phase Interventional Atrial Fibrillation (AF) Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Generated Avatar Videos and Chatbot for Clinical Trial Outreach.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF), Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

EVERYVET (Empowering VEterans in Research effectivelY Using Virtual Engagement Tools): A Patient-Centered Study

Overview

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.

Detailed description

Recent advances in artificial intelligence now enable the creation of personalized video avatars at negligible cost and time. These computer-generated videos can be rapidly adapted to describe any clinical trial and tailored to individual patient preferences in both speaker appearance and content.

The EVERYVET Study (Empowering VEterans in Research effectivelY using Virtual Engagement Tools) will evaluate whether these AI-supported tools can increase Veteran engagement in cardiovascular clinical trials compared to standard mailed letter invitations. The avatar invitations will be randomly embedded into outgoing invitations for existing VA clinical studies. Veterans will be able to choose their preferred avatar speaker from a diverse set of computer-generated Veteran and physician avatars and self-select the content topics most important to them. The study is co-designed with the Veterans and Family Research Engagement Council (VFREC) and a Veteran Co-Investigator to ensure the approach centers Veteran priorities and preferences throughout.

Interventions

  • Behavioral AI-Generated Avatar Videos and Chatbot for Clinical Trial Outreach
    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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Proportion of Veterans accessing the intervention website [Time frame: Baseline through 6 months]
  • Proportion of Veterans viewing avatar videos [Time frame: Baseline through 6 months]
  • Avatar preferences [Time frame: Baseline through 6 months]

Eligibility criteria

Inclusion Criteria (Aim 2):

  • 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

Exclusion Criteria (Aim 2):

  • Any exclusion criterion applied by the parent VA Cooperative Studies cardiovascular trial
  • Documented preference to opt out of VA research mailings

Inclusion Criteria (Aim 1 Qualitative Interviews):

  • 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

Exclusion Criteria (Aim 1 Qualitative Interviews):

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

Inclusion Criteria (Aim 1 Beta-Testing and Aim 3):

  • 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

Exclusion Criteria (Aim 1 Beta-Testing and Aim 3):

\- Inability to communicate in English at a level sufficient for survey completion

Inclusion Criteria (Focus Groups):

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07741955 · 87024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗