EXPIRED
National Institutes of Health (NIH)
Research on Informal and Formal Caregiving for Alzheimer's Disease (R01)
R01 Research Project Grant
New
PAR-15-348
PAR-15-351, R21 Exploratory/Developmental Research Grant
93.866, 93.361
This Funding Opportunity Announcement (FOA) invites applications for basic and translational research on caregiving for individuals with Alzheimer’s disease (AD), at the individual, family, community, and population level. The scope of this funding opportunity includes support for applications that propose the following: interventions to reduce caregiver burden and improve patient outcomes across various settings; population- and community-based research on the scope and impact of AD caregiving; improved characterization of informal and formal caregiving and the burden of caregiving across the full spectrum of the disease, including differences among socioeconomic, racial/ethnic and geographic sub-populations; and research addressing the unique challenges related to the provision of advanced AD care, including disparities in access to care.
September 17, 2015
November 11, 2015
Not Applicable
Any due dates on or after Jan 25, 2018 must use reissued FOA.
December 11, 2015 (New, Revision, and Resubmission applications) followed by Standard dates , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
Standard dates apply
Standard dates apply
Standard dates apply
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Alzheimer’s disease directly affects as many as 5.1 million people in the United States. The extensive care needs of individuals with AD are highly variable and care typically involves great demands on spouses and other family members, when they are available. Family caregivers may experience both adverse health consequences (e.g., disrupted sleep, anxiety, depression, and compromised immune function) and economic hardship as a result of lost work and care expenditures. The challenges of caregiving may lead family members to seek institutional (nursing home) placement for demented elders in place of informal care. For those families that either partially or fully use formal care options, the costs of such services are significant and often uninsured. How families organize resources to support formal care can affect the health and well-being of both the caregiver(s) and the care recipient with AD.
The recent National Alzheimer’s Project Act recognizes the need to enable family caregivers to continue to provide care while maintaining their own health and well-being and recommends the development and dissemination of evidence-based interventions for AD patients and their caregivers to reduce the burden of caregiving and delay nursing home placement. An essential activity of this legislation is to support research that leads to the development of strategies to "identify high-quality dementia-care guidelines and measures across care settings" and to "explore the effectiveness of new models of care for people with (AD)."
Recommendations from the 2012 Alzheimer’s Disease Research Summit, and the 2015 Alzheimer’s Disease Research Summit highlighted the need for research to better understand and address the caregiving challenges across different settings and over the complete trajectory of AD. Such research should take into account the differing needs and capabilities of individuals with AD and other forms of dementia and their families.
Critical needs in caregiving research have been recently identified (see Next Steps for Research on Informal Caregiving at: https://www.nia.nih.gov/research/dbsr/bsr-sponsored-publications). Specifically, these needs include: (1) improved definitions and characterization of caregiving throughout all of the progressive stages of AD, (2) deeper understanding of the health burden associated with caregiving, (3) assessment of how families support informal and formal care and the ramifications of these choices on their well-being, (4) identification of predictors of caregivers and care recipients at highest risk for poor outcomes, (5) development of novel interventions to meet the needs of caregivers and care recipients, and (6) development of novel approaches for integrating informal and formal care over the full trajectory of the disease.
In each of these areas, research is needed to understand and address the challenges faced by caregivers from diverse racial, ethnic, and socioeconomic backgrounds.
This Funding Opportunity Announcement encourages new research on informal and formal caregiving for individuals with AD in the following domains:
Cluster randomized trials for comparative effectiveness research on Alzheimer’s disease caregiver interventions:
There is an existing body of research on evidence-based interventions to relieve caregiver burden, and both NIA and NINR have supported the development of effective interventions, notably Resources for Enhancing Alzheimer’s Caregiver Health (REACH II), the NYU Caregiver Intervention, Care of Persons with Dementia in their Environments (COPE), and The Savvy Caregiver. What is not known, however, is whether other programs demonstrated to be effective in the context of trials conducted in clinical settings would be effective if implemented in different settings. Moreover, while many of these caregiving interventions have a positive impact on strain associated with caregiving, it is not known whether variable outcomes among them could indicate differential effectiveness in specific populations or geographic locations. Further, most caregiving interventions are provided through community agencies or institutions and have not carefully measured important psychosocial variables, caregiver health, or care recipient transition to nursing home care.
This FOA encourages researchers to partner with insurers (including CMS) to conduct comparative effectiveness research to determine which existing evidence-based interventions to reduce burden in caregivers and improve care recipient outcomes are effective if implemented as an adjunct to primary care in non-research settings. Interventions are needed across the full care continuum, including patients in a variety of settings (home, nursing home, assisted living, hospice), and for caregivers from diverse racial, ethnic, and socioeconomic backgrounds.
Cluster randomized trials are encouraged that will compare interventions stemming from contact with caregiver dyads in primary care, and where researchers can link the data obtained in the study with billing data. Such trials will allow researchers to follow longer range health effects of caregiving and assess the effectiveness of interventions.
Novel community- and technology-based interventions for informal Alzheimer’s disease caregivers:
Many existing interventions to relieve caregiver burden require extensive time and personnel commitment. There is a need for cost-effective, community-based, informal caregiving interventions and tools that address unmet psychological and physical health needs of caregivers; aid in assessment and management of AD symptoms; and ensure a safe home environment, where individuals with AD can remain for as long as possible. Community based caregiving involves a care recipient who either ages in place or remains within a community, but requires additional support from various sources. The source of caregiving may be informal in that family or others are responsible for caregiving; formal through the provision of services provided in the home from various agencies; or through a hidden economy consisting of paid caregivers without agency affiliations. Volunteer-initiated formalized programs to help older adults remain in their homes in the community are emerging in cities throughout the U.S. To date, however, there has been little dedicated research on their efficacy, nor any attempt to assess their impact on individuals suffering from AD and their family caregivers.
Interventions that leverage technology to support caregivers in the community or in the home are also encouraged. The recent 2015 Alzheimer’s Disease Summit highlighted the potential of technology for intervening in-home and in real time, and for monitoring adherence and other important intervention outcomes.
This FOA also encourages research partnerships with community organizations, particularly those that have potential to deliver programs at regional or national scale. Applications are encouraged that will lead to the development of effective in-home, in-community intervention programs and tools to support caregiver well-being and health, promote positive outcomes for care recipients, and aid in the integration of informal and formal care. Research encouraged also includes financial planning interventions aimed at anticipating costs of long-term services and supports and palliative care to help mitigate the effects of such financial strain on caregiver and care recipient health and well-being.
This announcement supports all stages of caregiver intervention development research, with the expectation that basic science research will be infused throughout each of these stages. Applicants are referred to the Stage Model for Behavioral Intervention Development: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development.
Understanding the scope and impact of familial support and care for persons with AD:
At the same time that population aging will put more individuals at risk for AD, demographic shifts in family composition (e.g., sequential marriages, rising levels of cohabitation and non-marital cohabitation, non-marital parenthood) could affect the availability of informal caregivers and increase the burden on those providing care. Economic factors associated with providing formal or informal care may also impact familial burden. Nationally representative, population-based studies can lead to a better understanding of the availability of family caregivers, their variable roles and diverse needs, changes in economic circumstances, and the barriers to receiving services and support. Multi-national studies can reveal how differences in policy and other factors affect care and outcomes.
This initiative encourages projects that will enhance our understanding of the socio-demographic profile of the caregiving population, in order to form a coherent picture of how AD caregiving impacts society. To this end, both national and cross-national population-based research is encouraged. Efforts supported under this initiative should enable researchers to identify predictors of high-risk caregivers; identify economic impact of informal caregiving on families and societies; and identify potential buffers and predictors of positive outcomes for caregivers and care recipients. For a further articulation of this need, see: Next Steps for Research on Informal Caregiving at: https://www.nia.nih.gov/research/dbsr/bsr-sponsored-publications.
Addressing these issues will require improved data infrastructure for the study of familial support for AD caregiving as well as projects that exploit new and existing data to address these issues. This includes analysis of existing data from existing cohorts of nationally representative and cross-national samples and determination of the need for data collection in new cohorts. Projects are encouraged that propose to supplement existing national panel studies to collect data on informal and formal caregiving. Projects are also encouraged that support the establishment of standard protocols for comparable data collection and data infrastructure on informal and formal caregiving.
Defining caregiving and assessing the impact of formal and informal care over the trajectory of AD:
Research on familial caregiving (informal caregiving) and research on Long Term Services and Supports (formal caregiving) have traditionally been pursued independently. There is a need for research to better define and assess the impact of informal and formal AD caregiving across a variety of settings (to include primary care, home health care, adult day care, nursing home, assisted living, hospice, etc.), in order to inform the design of new care delivery systems. One of the major challenges faced by caregivers is navigating the interface of informal and formal care, including determining appropriate care transitions and securing adequate care coordination.
Projects are encouraged that will lead to better definition and characterization of informal and formal caregiving, the domains of needs of caregivers and care recipients across the care continuum, the key social structural variables which contribute to variance in caregiving burden, and factors that characterize care delivery and care coordination models that reduce burden on caregivers and care recipients. Caregiving definitions should take into account the role of the caregiver in a regional and racial/ethnic context, as well as the scope and breadth of caregiving, availability of social and economic resources to caregivers, and the inevitable changes in caregiving needs as the disease progresses.
Research is encouraged on disparities in the nature of informal caregiving, access to and utilization of long-term supports and services, including home and community-based services, such as adult day care, as well as residential care, for those with dementia. Research on disparities in quality of care received in different settings, its antecedents and consequences, is also encouraged. Treatment of those with advanced dementia often includes inappropriate intensity and burdensome transitions; research is needed both to investigate reasons for disparities, which may include family preferences or lack of opportunities for informed choice. Interventions to address causes of disparities and improve access to high-quality care for disadvantaged populations is especially encouraged.
A deeper understanding of caregiving needs also requires improved assessments and characterization of the impact of caregiving on caregivers psychological and physical health, workforce participation and financial security. Assessments should be sensitive to both the potential benefits as well as burdens of the caregiving role. There is particular need for identification and validation of assessments suitable for use in a range of research contexts including observational and interventional studies and large population-based surveys.
Addressing challenges in advanced Alzheimer’s disease care:
Care for individuals with advanced AD poses particular challenges for caregivers, given the complexity of symptoms and the often protracted nature of decline in the last years of the disease. These challenges include managing (and reducing) unnecessary transitions between care contexts, making decisions about treatment options for comorbid conditions, avoiding burdensome treatments, addressing the palliative care needs of care recipients at the end of life, and supporting caregivers in their role as surrogate decision-makers for care recipients who are unable to make decisions for themselves.
This initiative seeks to support research on the caregiving challenges associated with advanced AD. Researchers are encouraged to develop interventions to aid caregivers in navigating the later stages of AD, in collaboration with health care professionals and other family members. There is potential to leverage existing palliative care research networks to develop and advance interventions for palliative and hospice care of persons with advanced AD and their families. Observational studies and interventions addressing practices of health and long-term care systems that lead to burdensome transitions for persons with advanced AD are encouraged. Cross-disciplinary efforts to design and test clinical interventions and models of palliative and hospice care for persons with advanced AD and their families are particularly encouraged. These programs should address needs across diverse subgroups, care settings, and rural/urban locales.
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All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
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See more tips for avoiding common errors.
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Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
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For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
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Not Applicable
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Not Applicable
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Melissa Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-451-4503
Email: geraldmel@mail.nih.gov
Karen Huss, , PhD, RN, APRN-BC, FAAN, FAAAAI
National Institute of Nursing Research (NINR)
Telephone: 301-594-5970
Email: hussk@mail.nih.gov
Gabriel Fosu, Ph.D.
Center for Scientific Review (CSR)
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Email: fosug@mail.nih.gov
John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: bladenj@mail.nih.gov
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov
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