NIH – Pragmatic Clinical Trials in Community Settings to Decrease or Prevent VCID Outcomes, Including in Populations that Experience Health Disparities (U01 Clinical Trial Required)

June 24, 2022 by dld5dt@virginia.edu

Purpose:

The purpose of this funding opportunity announcement (FOA) is to solicit applications for pragmatic clinical trials to decrease or prevent negative clinical outcomes due to vascular contributions to cognitive impairment and dementia (VCID), including locally representative NIH defined populations that experience health disparities in dementia. Examples of responsive projects and interventions that affect VCID outcomes include, but are not limited to, blood pressure control implementation; lifestyle modification using aerobic exercise; and early detection and treatment of VCID risk factors.

Background:

With the number one goal of the National Alzheimer’s Project Act (NAPA) being to prevent and effectively treat Alzheimer’s Disease and Related Dementias (AD/ADRD) by 2025, more work is needed to identify the best implementation strategies to leverage evidenced-based approaches to prevent, delay, or slow dementia onset and/or progression. This is particularly true in populations experiencing health disparities in the United States and who may also be facing increased socio-economic disadvantages that limit their interactions with health care providers. The NIH-designated populations that experience health disparities (HDPs) include racial and ethnic minority populations, less privileged socioeconomic status (SES) populations, underserved rural populations, and sexual and gender minorities (SGM)., and any subpopulations that can be characterized by two or more of these descriptions. More information regarding minority health and health disparities can be found at: Minority Health and Health Disparities: Definitions and Parameters.

Vascular contributions to cognitive impairment and dementia (VCID) are related to of modifiable risk factors such as hypertension and diabetes mellitus that require close monitoring and medical management. VCID occurs not only in diagnoses such as vascular cognitive impairment and vascular dementia, but also in clinical Alzheimer’s disease. This scope of this FOA is pragmatic interventions that decrease the burden of VCID in all diagnoses where VCID occurs. These management and monitoring needs are not well met in the general population, and particularly not well met in populations that experience health disparities. Additionally, lifestyle interventions that improve brain health and limit VCID progression may also be more limited or difficult to access in these populations due to socioeconomic factors, including medical insurance coverage. Therefore, there is a clear need for pragmatic clinical trials to decrease or prevent negative clinical outcomes due to vascular risk factors in NIH defined populations that are at high risk for experiencing health disparities in cognitive impairment and dementia.

For this funding announcement, pragmatic clinical trials (PCTs) are defined as studies designed for the primary purpose of informing decision-makers regarding the comparative balance of benefits, burdens, and risks of a biomedical or behavioral health intervention at the individual or population level. (Califf and Sugarman 2015). To achieve generalizable results in an efficient manner, embedded PCTs (ePCTs) commonly take place in the setting where patients already receive their usual clinical care. In contrast to traditional randomized controlled trials, the intention is to avoid the need for a separately constructed infrastructure with specially trained research staff responsible for data collection. For a broader, more representative population, eligibility criteria are minimized and recruitment expanded to potentially all eligible individuals receiving care in the participating setting, with a focus on those most likely to benefit clinically. Intervention delivery, participant follow-up, and adherence protocols are more flexible and closely align with usual care to understand the real-world implications of the intervention. Arguably, many of these pragmatic qualities occur along a spectrum, with some trials being more pragmatic than others (Thorpe et al. 2009). More information about the approach to and conduct of pragmatic trials conducted within real-life healthcare system settings may be found at the NIH Clinical Trial Collaboratory website: https://rethinkingclinicaltrials.org/ and within, “The NIH Collaboratory: Living Textbook of Pragmatic Clinical Trials.”

Key Dates:

Open Date (Earliest Submission Date): August 15, 2022
Letter of Intent Due Date(s): August 15, 2022
Applications Due: September 12, 2022

URL for more information:

https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-23-001.html

Filed Under: Funding Opportunities