Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings (R61/R33 - Clinical Trial Required) | PAR 18 585

Opportunity Information: Apply for PAR 18 585

The National Institutes of Health (NIH) funding opportunity PAR-18-585 supports pragmatic clinical trials focused on improving dementia care for people with Alzheimers disease (AD) and Alzheimers disease and related dementias (ADRD) who receive services in Long-term Services and Support (LTSS) settings. The central idea is to fund studies that answer practical, real-world questions that matter to patients living with dementia, clinicians, and caregivers, including both paid staff and unpaid family caregivers. Unlike tightly controlled efficacy studies, these projects are expected to be run in everyday care environments and structured so their findings can be used quickly by providers, organizations, patients, and caregivers.

A key expectation is that proposed trials are comparative and pragmatic, meaning they should test interventions, care strategies, or implementation approaches under routine conditions and with broad eligibility criteria. Applications are expected to enroll diverse populations and reflect the realities of LTSS, where staffing patterns, care workflows, and patient needs can vary widely. The goal is to generate evidence that is directly adoptable, not just academically interesting, and to do so in a way that supports rapid translation into practice.

The FOA emphasizes outcomes that improve the lives of people with dementia and those who care for them. Successful projects should be positioned to (1) improve the quality of care delivered to persons with dementia, (2) improve quality of life for persons with dementia and their informal caregivers, (3) deliver more patient-centered and cost-effective care within LTSS, and/or (4) reduce disparities in LTSS dementia care. In practical terms, that can include interventions that improve care processes, communication, symptom management, caregiver support, staff training, care coordination, or other approaches that can realistically be integrated into LTSS operations.

This opportunity uses a phased award structure (R61/R33) that supports a stepwise path from feasibility work to a larger pragmatic trial. The first phase functions as a pilot and feasibility stage intended to test whether an LTSS intervention can be implemented, integrated, and sustained in the targeted real-world settings. During this initial phase, applicants are expected to establish that recruitment, delivery, fidelity, data collection, and operational fit are workable, and to refine procedures needed for a larger trial. Progression to the second phase is not automatic; it depends on meeting predefined Go/No-Go milestones and criteria set for the early phase. If those criteria are achieved, the project can transition to the R33 phase to conduct the full-scale pragmatic trial.

The funding mechanism is a grant, and the activity category is health (CFDA 93.866). While the source data lists an award ceiling of $500,000, the FOA structure indicates support for pilot feasibility work followed by a larger pragmatic trial phase, with the transition governed by administrative review of milestone completion. The opportunity is labeled a clinical trial required announcement, signaling that funded projects must include a clinical trial component consistent with NIH definitions and expectations for trial conduct, oversight, and reporting.

Eligibility is broad and includes many types of organizations that operate, study, or influence LTSS and dementia care. Eligible applicants include state, county, city, township, and special district governments; public and private institutions of higher education; independent school districts; federally recognized tribal governments and other tribal organizations; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (including small businesses); and other entities. The FOA also explicitly highlights additional eligible applicants 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), faith-based and community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. (foreign) organizations. This breadth aligns with the FOA emphasis on diverse populations, community relevance, and real-world implementation capacity.

Overall, PAR-18-585 is geared toward producing actionable evidence on dementia care in LTSS by funding pragmatic, inclusive, real-world trials that can be adopted quickly, with an initial feasibility stage and a milestone-driven path to a larger implementation and effectiveness trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pragmatic Trials for Dementia Care in Long-term Services and Support (LTSS) Settings (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 2018-01-24.
• Applicants must submit their applications by 2020-02-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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.

Apply for PAR 18 585

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