Digital Artefacts LLC — Department of Health and Human Services STTR Phase II: 105

Digital Artefacts LLC — STTR Phase II award from Department of Health and Human Services.

Amount
$1,077,962
Agency
Department of Health and Human Services · National Institutes of Health
Program / Phase
STTR · Phase II
Topic
105
Solicitation
PA15-270
NAICS
Place of performance
IA
Period
2016-09-15 → 2019-08-31

Description

Despite significance advances in anti retroviral treatments HIV associated neurocognitive disorder HAND remains prevalent and can affect a broad range of everyday activities An effective brief cognitive screen that could be implemented in busy HIV clinics where clinicians have limited time to provide care for patients with complex medical psychiatric and cognitive conditions has the potential to significantly impact patient care in terms of both identifying patients who may warrant additional treatment considerations as well as the potential to track changes in cognition over time Unfortunately current brief cognitive screens have lacked sensitivity to the generally mild and mild to moderate deficits associated with modern HAND Phase I saw the development of a brief iPad based cognitive screening tool that could be self administered and exhibited good validity relative to a gold standard neuropsychological NP test battery and test retest reliability The test combination taking only minutes to complete produced very good classification accuracy with sensitivity specificity positive and negative predictive values all approximately The aims of Phase II are to enhance the technical capabilities and usability of the iPad based cognitive screen for both patients and clinicians improve the clinical relevance of the iPad based cognitive screening tool and establish the clinical utility of the revised tool To accomplish these aims we will improve the existing interface by creating a revised dashboard based upon input from senior clinicians and adapt it to present results in a user friendly and easily interpretable manner and add additional brief questions address mood and problems with everyday functioning In year we will develop demographically adjusted norms based upon healthy adults including norms for and month follow up assessments in order to optimize the tool for use in monitoring patients over time In year we will implement this new normed tool in HIV clinics in both San Diego and collaborating clinics in the United States At least HIV participants will complete the iPad measure in clinics and at a month or clinic visit approximating that time follow up A subset of these individuals n will also provide more detailed neuropsychological data captured during a clinic or research based evaluation We will then assess the effectiveness of the tool in detecting HIV related cognitive impairments based upon a gold standard assessment As a result of this project we will have a fully functional validated and marketable brief screening measure for evaluating patient cognition improving HIV patient care facilitating future studies of HAND and its treatment and which will position Digital Artefacts in a key leadership role in the development of user and clinician friendly screening measures for HAND as well as potentially other neurologic conditions Difficulties with memory concentration and thinking speed remain common in individuals with HIV infection despite effective medical treatments Current screening tests are not effective at detecting such impairments We aim to address this gap in care by developing a brief iPad based test that would alert physicians to cognitive difficulties and which could potentially result in alternative treatment strategies for patients