Opportunity Information: Apply for PAR 21 308
The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Pragmatic Trials for Dementia Care and Caregiver Support (R61/R33 Clinical Trial Required)" (Funding Opportunity Number: PAR-21-308; CFDA: 93.866). The focus is on funding pragmatic clinical trials in Stage IV of the NIH Stage Model, meaning the work should be mature enough to test how well an intervention performs in routine, real-world practice rather than under tightly controlled research conditions. The overall goal is to strengthen dementia care and caregiver support for people living with Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD) across multiple care settings.
This FOA is specifically aimed at pragmatic trials that answer practical, comparative questions that patients, clinicians, and caregivers face in everyday decisions. In other words, NIH is looking for studies that compare realistic care approaches, service models, or support strategies that could plausibly be adopted by health systems, community organizations, long-term services and supports, or caregiver programs. The trials should be designed so the results are immediately useful to real stakeholders, including people with dementia, unpaid family caregivers, and paid caregivers, as well as the clinicians and organizations delivering care.
A central expectation is that studies include broad and diverse populations and take place in real-world settings, with sample sizes large enough to produce credible, actionable findings. The emphasis on diversity is tied to improving generalizability and ensuring that evidence reflects the experiences of different communities, not just narrowly selected research participants. The real-world requirement also signals that interventions should be tested under routine constraints (typical staffing, workflows, resources, and patient complexity), which helps produce results that can be rapidly disseminated and implemented if successful.
NIH describes several outcomes that successful projects should aim to achieve. These include improving the quality of care for people with dementia, improving quality of life for people with dementia and their informal (unpaid) caregivers, delivering more patient-focused and cost-effective care across multiple settings, and/or reducing disparities in dementia care. The disparity component is important: applicants are encouraged to design studies that either directly target inequities (for example, differences in access, outcomes, or caregiver burden across populations) or at minimum measure and analyze outcomes in ways that can reveal whether benefits are equitably distributed.
The funding mechanism is an R61/R33 phased award, and a clinical trial is required. In many NIH programs, this structure is used to support an initial phase focused on final preparation and launch activities (for example, refining pragmatic trial procedures, confirming feasibility in the intended settings, and meeting prespecified milestones), followed by a second phase that supports full implementation and completion of the trial if the early milestones are met. The practical implication is that applicants should be ready to justify not only the scientific rationale, but also the operational readiness, partnerships with real-world sites, recruitment and retention approach, and how the trial will be embedded into routine care delivery.
Eligibility is broad and includes many types of organizations that could realistically run large, practice-based dementia care trials. Eligible applicants include state, county, and local governments; special districts; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, among others. The FOA also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and even non-U.S. (foreign) entities. This breadth reflects the reality that dementia care and caregiver support often occur outside traditional academic medical centers and may be delivered through community, tribal, territorial, or faith-based infrastructure.
Key administrative details included in the source information are that the agency is NIH, the program was created on 2021-08-11, and the original closing date listed is 2024-02-13. The award ceiling and expected number of awards are not specified in the provided data, which typically means applicants should consult the full FOA text or NIH grants guidance for budget expectations, allowable costs, and any institute-specific funding notes. Overall, this opportunity is designed for applicants who can run large, practical, real-world dementia care trials with clear adoption potential, strong partnerships in care settings, and outcomes that matter to patients and caregivers.Apply for PAR 21 308
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pragmatic Trials for Dementia Care and Caregiver Support (R61/R33 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
- This funding opportunity was created on 2021-08-11.
- Applicants must submit their applications by 2024-02-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the title of this NIH funding opportunity?
The opportunity is titled "Pragmatic Trials for Dementia Care and Caregiver Support (R61/R33 Clinical Trial Required)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR-21-308.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.866.
Which agency is offering this grant?
The agency is the National Institutes of Health (NIH).
What type of grant mechanism is being used?
This opportunity uses an R61/R33 phased award mechanism.
Is a clinical trial required under this FOA?
Yes. The FOA is explicitly labeled "Clinical Trial Required."
What is the overall purpose of this funding opportunity?
The overall goal is to strengthen dementia care and caregiver support for people living with Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD) across multiple care settings.
What kinds of studies is NIH seeking to fund?
NIH is seeking pragmatic clinical trials designed to answer practical, comparative questions that patients, clinicians, and caregivers face in real-world decision-making. The trials should compare realistic care approaches, service models, or support strategies that could plausibly be adopted by health systems, community organizations, long-term services and supports, or caregiver programs.
What does "pragmatic trial" mean in the context of this opportunity?
In this context, a pragmatic trial is designed to test how well an intervention performs in routine, real-world practice rather than under tightly controlled research conditions. This includes using typical staffing, workflows, resources, and accounting for real patient complexity.
What NIH Stage Model phase is this FOA targeting?
This FOA focuses on Stage IV of the NIH Stage Model, meaning interventions should be mature enough for testing in routine practice settings.
What are examples of interventions or strategies that fit this FOA?
Based on the description, appropriate interventions include realistic dementia care approaches, service delivery models, and caregiver support strategies that can be embedded in everyday care and that organizations could realistically adopt. The FOA emphasizes comparators that reflect real choices stakeholders face in practice.
What settings should the trials take place in?
Trials are expected to take place in real-world settings where dementia care and caregiver support are actually delivered, across multiple care settings. The emphasis is on routine practice environments rather than specialized research-only environments.
Who should benefit from the results of these trials?
The results should be immediately useful to real stakeholders, including people with dementia, unpaid family caregivers, paid caregivers, clinicians, and organizations delivering care.
Are applicants expected to include diverse populations?
Yes. A central expectation is that studies include broad and diverse populations to improve generalizability and ensure evidence reflects different communities, not only narrowly selected research participants.
How important is sample size in this FOA?
The FOA emphasizes sample sizes large enough to produce credible, actionable findings, consistent with the goal of generating practical evidence for real-world adoption.
What outcomes are projects expected to improve or measure?
NIH describes several targeted outcomes, including improving quality of care for people with dementia, improving quality of life for people with dementia and their informal (unpaid) caregivers, delivering more patient-focused and cost-effective care across multiple settings, and/or reducing disparities in dementia care.
Does the FOA address health equity or disparities?
Yes. Reducing disparities is a highlighted outcome area. Applicants are encouraged to design studies that directly target inequities or, at minimum, measure and analyze outcomes in ways that show whether benefits are equitably distributed.
What does the R61/R33 phased structure imply for applicants?
The R61/R33 structure typically supports an initial phase focused on final preparation and launch activities (such as refining pragmatic trial procedures, confirming feasibility in intended settings, and meeting prespecified milestones). If milestones are met, the award can transition to a second phase that supports full implementation and completion of the trial.
What kinds of readiness elements are implied by this FOA?
Applicants should be prepared to justify scientific rationale and operational readiness, including partnerships with real-world sites, recruitment and retention approach, and how the trial will be embedded into routine care delivery.
Who is eligible to apply?
Eligibility is broad and includes, among others: state, county, and local governments; special districts; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.
Are community-based or faith-based organizations eligible?
Yes. The FOA highlights faith-based and community-based organizations as eligible applicants.
Are Tribal organizations and Tribal-serving institutions eligible?
Yes. Eligibility includes federally recognized Native American tribal governments and other tribal organizations, as well as Tribally Controlled Colleges and Universities (TCCUs).
Are minority-serving institutions eligible?
Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are U.S. territories or possessions eligible to apply?
Yes. The FOA indicates that U.S. territories or possessions are included among eligible applicants.
Are non-U.S. (foreign) entities eligible?
Yes. The FOA notes that non-U.S. (foreign) entities are eligible.
Are federal agencies eligible to apply?
Yes. Eligible applicants include eligible federal agencies.
When was this program created?
The provided information states the program was created on 2021-08-11.
What is the original closing date listed for this opportunity?
The original closing date listed is 2024-02-13.
Is the award ceiling listed in the provided information?
No. The award ceiling is not specified in the provided data.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided data.
What should applicants do if they need budget expectations or allowable cost details?
Because award ceiling and expected number of awards are not included in the provided information, applicants are typically expected to consult the full FOA text or NIH grants guidance for budget expectations, allowable costs, and any institute-specific notes.
What is the key theme NIH is emphasizing across the FOA?
The key theme is actionable, real-world evidence: pragmatic trials embedded in routine care that compare realistic approaches, include broad and diverse populations, and generate findings that can be rapidly disseminated and implemented if successful.
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