I-FUNCTION, INC. — Department of Health and Human Services SBIR Phase II: NIA

Description

People with cognitive impairments such as Mild Cognitive Impairment (MCI), often experience difficulty performing everyday routine activities. Further, normative age-related changes in cognition often lead to deficits on previously learned skills and impede new learning such as learning of new technology systems. This is of great concern, given population aging, the increasing number of older adults with cognitive impairments, and the continual deployment of new technologies in everyday contexts. The proposed SBIR Phase II study will refine and further evaluate a novel integrated computer-based functional skills assessment and training (CFSAT) program that provides training on everyday tasks critical to independent living (e.g., financial and medication management). The program tasks are veridical representations of everyday activities and real world systems. The training is tailored to the individual via the assessment component. Phase I of the study will involve further refinement and usability testing of the program. Phase II will involve a randomized trial with 40 non-impaired older adults (NC) and 120 adults with MCI. MCI participants will be randomly assigned to the CFSAT condition, the CFSAT combined with a computer-based cognitive training (CCT) condition, or an active CCT control condition. The NC participants will be assigned to the CFSAT condition. Important aims of the study are to examine near and far transfer of training and dosing. Our design is efficient and will allow us to: gather data for both impaired and non-impaired adults on transfer and dosing; further examine the benefits of direct functional skill training relative to CCT on functional skills (FS) for those with MCI; and determine if CCT provides a priming effect that enhances the benefits of the CFSAT program for those with MCI. Our primary outcome measures include objective measures of functional abilities, and ecological momentary assessment of real-world performance collected from self and informant reports in the training task domains. Secondary outcomes include measures of self- efficacy, quality of life and the acceptability and usability of the CFSAT program. We will also gather data on maintenance of training gains, the need for booster training, and adherence to home-based training. The overall objective of the proposed Phase II study is to develop an integrated commercially available technology-based functional skills assessment and training program that can be deployed on a variety of technology platforms and used in a variety of settings (e.g., clinical settings, home environments) with diverse adult populations. Our long-term goal is to develop a commercially successful product that can help prevent and treat functional declines and maintain the cognitive health and functional independence of older adults.The population is aging and cognitive impairments, which impact on abilities important to everyday functioning and threaten independence, are common among older adults. This Phase II study will further refine and evaluate a novel technology-based integrated functional-skills assessment and tailored training program (CFSAT), that can be deployed on a variety of technology platforms and used in a variety of settings with diverse adult populations including those with mild cognitive impairment. Our long-term goal is to develop a commercially viable product that can enhance functional skills, help prevent or treat functional declines, and foster the functional independence and well being of older adults.