Inspiring Healthy Engagement and Learning for Vascular Dementia (I-HEAL)

While vascular dementia is recognized as the second most common form of dementia and the leading nondegenerative cause of dementia, vascular contributions to cognitive impairment and dementia (VCID) have not been thoroughly studied among residents in the Stroke Belt. Vascular disease may be present in the majority of dementia cases in varying degrees, including in Alzheimer’s disease, accounting for 60-80% of dementia cases. Individuals in the Stroke Belt experience a higher prevalence of risk factors for stroke (e.g. smoking and obesity) as well as chronic disease associated with stroke (e.g. hypertension, diabetes, and coronary heart disease) compared to individuals in other US regions, placing this population at risk of cerebrovascular pathologies that may lead to cognitive impairment or dementia. In addition, lifestyle and non-medical drivers of health factors put this population at an increased risk of cardiovascular disease (CVD) and dementia. Without increased participation in VCID clinical trials to thoroughly understand VCID, gaps in understanding the safety and effectiveness of therapies in this population will persist. Clinical trial readiness—encompassing factors that influence participation and the ability to engage in clinical trials—is a critical area of research to improve VCID clinical trial participation. Examining factors influencing readiness and developing tailored, innovative strategies to improve participation in VCID clinical trials has the potential to reduce gaps in adverse health outcomes. Inspiring Healthy Engagement and Learning for Vascular Dementia (I-HEAL), submitted in response to RFA-NS-25-013, focuses on addressing gaps in VCID clinical trial participation among Americans, with an emphasis on populations residing in the Stroke Belt, a region in the southeastern United States with a higher incidence of stroke mortality compared to the rest of the United States. We have assembled an I-HEAL learning network of 6 universities, including 3 Alzheimer’s Disease Research Centers located in or near the Stroke Belt to reach varied stakeholders. Our methods leverage upstream and downstream approaches to co-create a VCID clinical trial readiness educational program with dementia and community engagement researchers and members of communities throughout the stroke belt. In this project, we will develop and validate a VCID clinical trial readiness and preparedness measure, PREP (Promoting Readiness, Engagement, and Participation) for VCID Trials Scale (Aim 1). Next, our team will develop and evaluate a customizable, multi-media clinical trial readiness educational program designed to prepare communities for participation in VCID clinical trials. Last, we will build a community-based workforce (I-HEAL Champions) prepared to engage and educate communities in CVD and VCID, VCID risk factors, clinical trial processes, human subject protections, and community engagement at the 6 I-HEAL study sites.