Frequently Asked Questions for PAR-21-307: Dementia Care and Caregiver Support Intervention Research (R01 Clinical Trial Required)
Funding Opportunity PAR-21-307
1. What is the overall goal of this Funding Opportunity Announcement?
The overall goal of PAR-21-307 is to support mechanism-focused dementia care and caregiver intervention development research at Stages I through V of the NIH Stage Model, to address the care needs and promote the health, function, and well-being of persons with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) and of those providing their care. For more information, see the “Funding Opportunity Purpose” and the “Funding Opportunity Description” in the FOA.
PAR-21-307 and PAR-21-308 are considered “companion” PARs.
PAR-21-307 utilizes the R01 Activity Code and supports only ONE Stage of dementia care and caregiver support intervention development research (Stage I, II, III, IV, or V). PAR-21-307 will not support applications that propose two or more stages of behavioral intervention development research.
PAR-21-308 utilizes the R61/R33 Activity Code and supports research on TWO (and no more than two) different Stages of dementia care and caregiver support intervention development research. More specifically, PAR-21-308 is for applicants whose interest is in conducting a large Stage IV pragmatic trial, but who require preliminary work at an earlier Stage (either Stage I or Stage III) before proceeding to a large Stage IV pragmatic trial. In the R61 phase, PAR-21-308 supports Stage I or Stage III research. If R61 milestones are met, there can be progression to the R33 phase. In the R33 phase, PAR-21-308 supports large Stage IV pragmatic trials. Please note that funding of the R61 phase does not guarantee funding of the R33 phase (see the “Milestones and R61/R33 Transition” sub-section of the announcement’s Part 2 Section 1.)
3. What is the NIH Stage Model?
The NIH Stage Model is a conceptual framework for behavioral intervention development that supports the development of potent and scalable behavioral interventions that are defined by their principles. Learn more about the NIH Stage Model.
4. What is meant by the “principles” of an intervention?
Within the NIH Stage Model, interventions are defined by their governing principles; in other words, the principles that are responsible for the effects of the intervention. In PAR-21-307, the word “principles” is essentially synonymous with the “mechanisms” by which an intervention is hypothesized to change behavior (see discussion of mechanisms at the Science of Behavior Change website).
Understanding the mechanisms of behavior change of an intervention involves positing a hypothesis regarding how the intervention engages precise mechanistic targets, testing to see if the intervention has the desired impact upon those targets, and determining if there is a causal relationship between engaging the targets and the desired clinical outcome.
5. What does fidelity mean in the NIH Stage Model?
“Fidelity” refers to the degree to which the intervention can be administered in a manner consistent with its governing principles.
6. How important is fidelity in the NIH Stage Model?
Very important. Since a goal of the NIH Stage Model is to ensure that efficacious interventions can be administered correctly by those in the community responsible for their delivery, ensuring fidelity to an intervention’s principles is critical.
7. Methods to train people are needed to ensure that an intervention can be delivered with fidelity. Does PAR-21-307 support research to develop training procedures?
Since delivery of an intervention with fidelity in community settings or health systems is of utmost importance, PAR-21-307 supports research to create, refine, and test training materials and procedures. Within the NIH Stage Model, developing methods to train community providers to administer an intervention correctly is considered to be Stage I research. Testing these methods may occur in both Stage I and Stage III. Applications submitted to PAR-21-307 can propose research to develop training materials and procedures within one of these stages.
8. In what Stage of research can training materials be developed and tested?
- Stage I includes research on the creation, adaptation, feasibility, and acceptability of scalable training materials for community providers. Stage I also may include initial testing to determine if community providers can deliver the intervention with fidelity.
- Stage III involves clinical trials that test the degree to which the training materials enable a community provider to administer an intervention with fidelity and to sustain faithful delivery. This may be done while simultaneously testing the efficacy of an intervention.
9. Are applications required to identify the Stage of the NIH Stage Model?
Yes. A clinical trial proposing one specific Stage of the NIH Stage Model must be clearly indicated as the primary specific aim. PAR-21-307 states that applications that do not propose a clinical trial, identified as Stage I, II, III, IV, or V, as the primary specific aim will be considered nonresponsive and will not be reviewed.
10. May a single application in response to PAR-21-307 propose to study more than one Stage of the NIH Stage Model?
No. PAR-21-307 is not a phased award. PAR-21-307 states that applications must identify Stage I, II, III, IV, or V as the primary specific aim. Applications may propose only one Stage in response to PAR-21-307.
Please note: The companion PAR, PAR-21-308, "Pragmatic Trials for Dementia Care and Caregiver Support (R61/R33 – Clinical Trial Required)," calls for a phased award. However, PAR-21-308 supports only “Stage I or Stage III pilot research to test the feasibility of implementing and integrating interventions (R61 phase) that, if successful, can transition to an R33 phase (Stage IV) for implementation of large pragmatic trials.”
11. Are applications required to state the hypothesized mechanism of action of the intervention being studied?
Yes. A hypothesis regarding the mechanism of action of the intervention under development must be described, and the quantitative data upon which the hypothesis is based must be stated. PAR-21-307 states that applications that do not propose a hypothesized mechanism of action or hypothesized essential ingredients based upon quantitative data will be considered nonresponsive and will not be reviewed.
12. Are applications required to test the hypothesized mechanism of action of the intervention under development?
As noted above, PAR-21-307 states that applications must propose a hypothesized mechanism of action or hypothesized essential ingredients based upon quantitative data. It further states that if the application does not propose a hypothesized mechanism of action, the application will be considered nonresponsive and will not be reviewed. Although testing this hypothesis is technically not a requirement, applicants should be aware that reviewers may question why a proposed study design does not test the hypothesized mechanism of behavior change of the intervention.
13. Is there anything else that would make my application unresponsive to PAR-21-307
Yes. It is always important to ensure your application meets all requirements, and these requirements are explicit in PAR-21-307. Please note this section unique to PAR-21-307: “Applications Not Responsive to this FOA.”
14. When are applications due? Where are the application due dates, review dates, and funding dates?
Applications are being accepted through February 13, 2024, and an application’s submission date determines when it will be reviewed and, thus, when funding, if awarded, will be provided.
Specific application due dates are found in the table in the “Key Dates” section of the FOA by choosing the targeted start month and year of one’s project from the table’s righthand column and identifying the corresponding date in either of the two leftmost columns of the table. All applications must be received by 5:00 PM local time of the applicant’s organization.
15. Are foreign institutions eligible?
Yes. Non-domestic (non-U.S.) entities (foreign institutions) and non-domestic (non-U.S.) components of U.S. organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
16. How many projects will be funded?
The number of awards is contingent upon scientific and technical merit of the proposed projects as determined by scientific peer review, availability of funds, and relevance of the proposed projects to program priorities.
17. Is a letter of intent requested for PAR-21-307?
Yes. Prospective applicants are asked to submit a letter of intent, including the following information, at least 30 days prior to their application due date:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity.
The letter of intent for an application in response to PAR-21-307should be sent to the FOA’s Scientific/Research Contact:
A letter of intent is not required, is not binding, and does not enter into the review of a subsequent application. However, the information that it contains allows staff to estimate the potential review workload and plan accordingly.