Atrial Fibrillation (AF)EVERYVETNCT07741955
Empowering Veterans in Research Effectively Using Virtual Engagement Tools
A study testing AI-Generated Avatar Videos for Clinical Trial Outreach in people with Atrial Fibrillation (AF) and Cardiovascular Diseases, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF), Cardiovascular Diseases
- What is being tested?
- AI-Generated Avatar Videos for Clinical Trial Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran receiving a mailed invitation to participate in the parent VA Cooperative Studies cardiovascular trial (therefore meeting inclusion criteria of the parent VA Cooperative Studies trial)
- 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
Who cannot join
- Any exclusion criterion of the parent VA Cooperative Studies cardiovascular trial
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Nicholas Vesom, MPH CCRP, (650) 493-5000, nvesom@pavir.org
Celina M. Yong, MD MBA MSc
About this study
Official title: EVERYVET (Empowering VEterans in Research effectivelY Using Virtual Engagement Tools): A Patient-Centered Study
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.
Read the 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 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.
- Conditions
- Atrial Fibrillation (AF), Cardiovascular Diseases
- Being tested
- AI-Generated Avatar Videos for Clinical Trial Outreach
- Keywords
- Veterans, Clinical Trial Recruitment, Cardiovascular Disease, Artificial Intelligence, Patient Engagement, Health Literacy, Virtual Outreach
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Generated Avatar Videos for Clinical Trial OutreachBehavioural
Also called AI-Supported Patient Engagement Tool
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AI-Generated Avatar Videos for Clinical Trial Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 6 months
Secondary outcomes (3)
Proportion of Veterans accessing the intervention website
Process measure assessing engagement with the QR code and URL among Veterans randomized to the intervention arm.
Measured: Baseline through 6 months
Proportion of Veterans viewing avatar videos
Process measure assessing video viewing behavior tracked through unique de-identified research numbers.
Measured: Baseline through 6 months
Avatar preferences
Frequency distribution of avatar speaker selections among Veterans who accessed the website
Measured: Baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Palo Alto Veterans Institute for Research, Stanford University
- Responsible party
- Sponsor
- Investigators
- Celina M. Yong, MD MBA MSc, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741955
- Sponsor's protocol ID
- HSR2-026-25W
- Other IDs
- 87024
- Acronym
- EVERYVET
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVERYVET (Empowering VEterans in Research effectivelY Using Virtual Engagement Tools): A Patient-Centered Study
- ClinicalTrials.gov ID
- NCT07741955
- Acronym / sponsor ID
- EVERYVET / HSR2-026-25W
- Conditions
- Atrial Fibrillation (AF), Cardiovascular Diseases
- Keywords
- Veterans, Clinical Trial Recruitment, Cardiovascular Disease, Artificial Intelligence, Patient Engagement, Health Literacy, Virtual Outreach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Palo Alto Veterans Institute for Research, Stanford University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: AI-Generated Avatar Videos for Clinical Trial OutreachVeterans 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Veteran receiving a mailed invitation to participate in the parent VA Cooperative Studies cardiovascular trial (therefore meeting inclusion criteria of the parent VA Cooperative Studies trial)
- 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
Key exclusion criteria (4 listed)
- Any exclusion criterion of the parent VA Cooperative Studies cardiovascular trial
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Generated Avatar Videos for Clinical Trial OutreachAlso: AI-Supported Patient Engagement ToolVeterans 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. | Behavioural | Experimental: AI-Supported Virtual Outreach |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Celina M. Yong, MD MBA MSc principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Generated Avatar Videos for Clinical Trial Outreach in people with Atrial Fibrillation (AF) and Cardiovascular Diseases, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Vesom, MPH CCRP ((650) 493-5000, nvesom@pavir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.