The goal of the current Phase I project is to develop (to clinical trial readiness) and evaluate the feasibility and initial efficacy of a mobile application, HeartMapp, designed to monitor and treat physical and cognitive symptoms related to heart failure (HF) in older adults. Heart failure (HF) is a leading cause of death in the US with costs estimated at $32 billion per annum, fueled by the high rates of re-hospitalization following initial acute hospitalization. As a group, individuals with HF experience cognitive difficulties in attention, memory and speed of processing, which interfere with good HF self-care and result in poor long-term prognosis, as indicated by negatively impacted quality of life and increased risk of mortality. There is therefore an urgent need to focus on early and continual monitoring of both physiological and cognitive status and deployment of cognitive and physiological interventions, in-the-moment, to improve and maintain adequate self-care. Here, we propose to complete the development and testing of HeartMapp, an innovative mobile app that enables remote physiological and cognitive monitoring of HF patients, and includes cognitive rehabilitation treatments that are delivered in the moment, based on cognitive assessment data. As a Point-of-Care (POC) device, HeartMapp has an intuitive online dashboard that help clinicians to continuously monitor and track patient data collected remotely, serving as an open channel between patients and clinicians. HeartMapp is the first app to support remote rigorous testing in HF patients, and support cognitive enhancement options. Our preliminary data is among the first evidence to demonstrate that physiological self-monitoring and cognitive treatment can improve cognitive status and HF self-care. At the completion of this project we will have outcomes data sufficient to support a large scale randomized controlled trial in Phase II (medical-device trial) designed to establish medical claims defining the efficacy of this intervention to treat symptoms of HF. At the completion of Phase II, we expect to have sufficient data for submission to the FDA for clearance as a medical device indicated for cognitive enhancement in heart failure patients.
The goal of this project is to further develop (to pivotal trial readiness) and evaluate a mobile application (HeartMapp) designed for POC self-monitoring and treatment of physical and cognitive symptoms of heart failure in older adults. This intervention may benefit a large population of vulnerable older adults that suffer cognitive decline and poor self-care following heart failure.
