Technology to Detect, Monitor and Assess Daily Functions in Individuals with Cognitive Decline, Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD) (R43/R44 Clinical Trial Not Allowed)

Background

The Small Business Innovation Research (SBIR) program is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated and the United States gains entrepreneurial spirit as it meets its specific research and development needs.

This SBIR FOA aims to stimulate the development of mobile-based measurement technology that assesses performance of functional tasks by independent-living older individuals.  Functional tasks, what some term instrumental activities and activities of daily living (IADLs/ADLs), include such essential activities as using a telephone (or a cellphone), shopping, doing laundry, preparing nutritionally adequate meals, taking prescribed medications, cleaning the house, and managing finances.

Research has shown that changes in the performance of IADLs/ADLs can also predict deterioration in cognitive function, including the development and onset of dementia. In addition, accurate IADL/ADL measures can help to inform family members, caregivers, and health-care providers about the functional status and needs of independent-living older individuals.

Given the relations between performance of IADLs/ADLs, physical health and cognitive function, and independent living, researchers have developed an array of indicators and instruments to measure and track the trajectory of performance of IADLs/ADLs in older individuals.  In fact, data collected with IADL/ADL measures figure prominently in gerontological research across natural (biological sciences, including neuroscience) and social-scientific disciplines, and are often used to characterize and predict physical and cognitive decline and dementia, as well as to develop interventions to arrest the development and/or mitigate the effects of decrements in physical health and cognitive function.

However, the experience of growing older in America is changing and many older adults live alone and may not have family caregivers or close friends to make accurate assessments of their daily function.  Such assessments may facilitate and inform efforts to prevent unwanted and adverse health and life outcomes.

In addition, many clinical research studies or interventional therapeutic clinical trials, focusing on cognition and/or dementia require a "study partner," someone who accompanies study participants on periodic visits for clinical assessment. Efforts to increase participation in such studies by older members of underserved and under-represented populations have been complicated as many are particularly isolated. The opportunity to remotely measure these functional abilities in real world situations may reduce the need for the "study partner" and for the participants to travel to medical or academic centers, thereby increasing recruitment success while at the same time, allowing more diverse and at-risk participants.

Many current IADL/ADL scales assess or sample only a single domain of function or performance, which limits the range and type of potentially useful data/information that can be collected and investigated.  Other scales may include more domains of function but are longer, more challenging to complete, and may require training to administer.  Furthermore, many scales use discrete rather than continuous indicators, which may not be advantageous.  Measurements of discrete data typically require larger samples (more data points), may yield lower sensitivity, and may limit the kinds of analysis that can be done.  Finally, many existing measures only indirectly assess the functions they are aiming to capture.  New technological solutions can be designed to address many of these limitations.

Enhanced mobile-based measures would be useful in the early detection of changes in IADL/ADL performance.  Early detection of decrements in IADL/ADL performance would allow researchers, physicians, and caregivers to identify and monitor increasing risks for deteriorating cognitive function (progressing from a subjective memory complainer to MCI and from MCI to AD/ADRD). 

Innovations in technology are revolutionizing health-related research, allowing for more frequent, more accurate, more inclusive assessments of research participants in their normal environments relative to assessments conducted at a clinical research center.  Today's middle aged and older adults are increasingly using technology, including smart phones and other mobile devices.  Recent data from US studies illustrates that smartphone usage is roughly equivalent across different racial and ethnic groups.  Additionally, many of the newer technologies require less active engagement, knowledge, and effort on the part of the users (e.g., wearable accelerometers).  There is considerable opportunity to dramatically advance understanding of everyday functioning and the relationship to cognition for diverse (racial, ethnic, socio-economic) populations of aging adults and those individuals with AD/ADRD.

Objectives

The goal of this announcement is to encourage research grant applications to develop wearable, mobile, or other technology to enable direct, objective, and continuous data capture of everyday functions in individuals at risk for and with AD/ADRD. Mobile technology now affords an opportunity to enhance the sensitivity and utility of IADL/ADL data in dementia research and particularly in research focused on interventions for AD and related dementias of aging using unobtrusive, direct, objective, multi-domain, continuous, and real-time measures.

Projects should be relevant to NIA programs and priorities as described in the NIA 2015 Alzheimer's Disease Research Summit recommendations, which are available at:  https://www.nia.nih.gov/research/recommendations-nih-ad-research-summit-2015. 

The following functional activities should be considered for inclusion:

• management of medical and social appointments;
• financial and transaction monitoring;
• engagement in social activities;
• shopping;
• engaging in hobbies or other personal interests;
• doing chores at home (i.e., laundry, cleaning);
• operating appliances or gadgets
• preparing meals;
• managing medications;
• driving; and
• maintaining personal hygiene (i.e., bathing, brushing teeth, etc.).

Applicants are encouraged to consider steps taken to demonstrate the psychometric viability (that is, validity and reliability) of any measurement constructs developed for the proposed mobile-based IADL/ADL measurement technology.  Furthermore, NIA anticipates that the IADL/ADL data collected with the use of mobile-based technology will be amenable to data-reduction techniques and other quantitative analytical methods.

Finally, NIA also encourages applicants to incorporate data-security architecture into the research and development of the mobile-based measurement technology.

See Section VIII. Other Information for award authorities and regulations.