Empowering Veterans in Research Effectively Using Virtual Engagement Tools

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

• Proportion of Veterans accessing the intervention website [Срок оценки: Baseline through 6 months]
• Proportion of Veterans viewing avatar videos [Срок оценки: Baseline through 6 months]
• Avatar preferences [Срок оценки: Baseline through 6 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07741955 · 87024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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