POSIT SCIENCE CORP — Department of Health and Human Services SBIR Phase I: 600

Description

PROJECT SUMMARY The goal of the current Phase I project is to developto clinical trial readinessand evaluate the feasibility and initial efficacy of a mobile applicationHeartMappdesigned to monitor and treat physical and cognitive symptoms related to heart failureHFin older adultsHeart failureHFis a leading cause of death in the US with costs estimated at $billion per annumfueled by the high rates of re hospitalization following initial acute hospitalizationAs a groupindividuals with HF experience cognitive difficulties in attentionmemory and speed of processingwhich interfere with good HF self care and result in poor long term prognosisas indicated by negatively impacted quality of life and increased risk of mortalityThere is therefore an urgent need to focus on early and continual monitoring of both physiological and cognitive status and deployment of cognitive and physiological interventionsin the momentto improve and maintain adequate self careHerewe propose to complete the development and testing of HeartMappan innovative mobile app that enables remote physiological and cognitive monitoring of HF patientsand includes cognitive rehabilitation treatments that are delivered in the momentbased on cognitive assessment dataAs a Point of CarePOCdeviceHeartMapp has an intuitive online dashboard that help clinicians to continuously monitor and track patient data collected remotelyserving as an open channel between patients and cliniciansHeartMapp is the first app to support remote rigorous testing in HF patientsand support cognitive enhancement optionsOur preliminary data is among the first evidence to demonstrate that physiological self monitoring and cognitive treatment can improve cognitive status and HF self careAt the completion of this project we will have outcomes data sufficient to support a large scale randomized controlled trial in Phase IImedical device trialdesigned to establish medical claims defining the efficacy of this intervention to treat symptoms of HFAt the completion of Phase IIwe expect to have sufficient data for submission to the FDA for clearance as a medical device indicated for cognitive enhancement in heart failure patients PROJECT NARRATIVE The goal of this project is to further developto pivotal trial readinessand evaluate a mobile applicationHeartMappdesigned for POC self monitoring and treatment of physical and cognitive symptoms of heart failure in older adultsThis intervention may benefit a large population of vulnerable older adults that suffer cognitive decline and poor self care following heart failure