Pilot Grants Program
The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory (U54AG063546) was established in 2019 to build the nation’s capacity to conduct embedded pragmatic clinical trials (ePCTs) of non-pharmacologic interventions within health care systems to improve the care of people living with AD/ADRD and their care partners. The NIA IMPACT Collaboratory funds several one-year pilot studies annually, which are meant to generate the preliminary data necessary to design and conduct a future full-scale ePCT funded through other grant mechanisms (National Institutes of Health or other sources). The IMPACT Collaboratory encourages applications that address dementia care for people of all backgrounds and promote health equity.
In response to the coronavirus disease (COVID-2019) outbreak, in this award cycle, the IMPACT Collaboratory will prioritize applications proposing pilot ePCTs of telemedicine, telehealth, and remote technologies interventions aimed at improving the health care, unmet needs, quality of life and/or health outcomes for people living with AD/ADRD and their care partners. Applications for pilot ePCTs testing other types of non-pharmacological interventions in this population will also be considered.
The IMPACT Collaboratory provides guidance for investigators in the design, conduct, and dissemination of ePCTs through its Core Groups and Teams:
Funding Opportunity Description
This cycle, the IMPACT Collaboratory will fund up to 5 one-year, non-renewable pilot studies. No-cost extensions are generally not allowed, but will be considered only in exceptional circumstances, require NIA approval, and are not guaranteed.
Pilot studies must:
- Pilot test a non-pharmacological intervention targeting people living with AD/ADRD and/or their care partners using an embedded pragmatic trial design.
- Implement the intervention in two or more health care systems or sites (e.g., nursing homes, hospitals, healthcare provider practices). Randomization is NOT required.
- Evaluate an intervention with a reasonable evidence-base demonstrating its efficacy as described in the Readiness Assessment for Pragmatic Trials (RAPT) Model paper. Telemedicine, telehealth, and remote technologies interventions will be prioritized.
- Be feasible within the one-year time frame.
- Be no more than minimal risk to human subjects in accordance with Federal regulation 45 CFR §46.102(j).
- Be designed to qualify for a waiver or alteration of informed consent in accordance with Federal regulation 45 CFR §46.116(f)(3)(i.-v.).
- Have a single, primary clinical outcome that can be collected pragmatically. The main purpose of delineating a primary outcome is to demonstrate the feasibility of collecting it pragmatically during the pilot study. The pilot study is NOT expected to be powered to demonstrate an effect of the intervention. Secondary outcomes evaluating the implementation experience and other clinical outcomes are encouraged.
- Have high alignment with stakeholder priorities. Stakeholders include but are not limited to: people living with dementia, care partners, frontline providers, healthcare systems, and/or payers.
- Include a qualified biostatistician on the research team.