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Difficulties in performing instrumental activity of daily living (IADL) is often an indicator of cognitive decline in older adults, and monitoring IADL and daily functioning can assist in early diagnosis of dementia. The current methods for assessment of IADL are often restricted to a single domain assessment (e.g. managing medication), or rely on subjective reporting by the patient or caregivers. Patients with mild AD typically lack awareness of their IADL deficits and generally overestimate their functional capacity. Proxies are also not always a reliable source of information, as they have a tendency to over or underestimate IADL deficits. In some cases, a proxy is not available or does not have enough knowledge about the patient's functional capacity. Direct measures taken during performance of IADL-related tasks in the clinic have better validity and do not suffer from reporter bias. However, they allow observation of only a small set of tasks and, even then, are quite time-consuming. To date, there are no objective methods for continuous and remote monitoring and assessment of IADL. The National Institute on Aging (NIA) has identified this need and released a specific request for SBIR/STTR applications. In response, BioSensics, in collaboration with Baylor College of Medicine (BCM), proposes to develop and commercialize a robust system for objective and continuous remote monitoring of IADL. This innovative platform, called IADLSys, will detect the timing and type of IADL for a wide range of daily functions, and will also monitor the user's physical activity and life-space.
This innovative platform, called IADLSys, will detect the timing and type of IADL for a wide range of daily functions, and will also monitor the user's physical activity and life-space. There are two key aspects of the technology: 1) physical tags (pTAGs): a series of sensors that can be attached to various objects to monitor the user's interaction with these objects, 2) PAMSys+: a pendant wearable sensor to monitor physical activity and the user's proximity to the pTAGs. As a part of this development, the investigators will create a base station to collect and transfer data from wireless sensors and wearable pendant to a secure backend cloud. A secure website will be developed to allow caregivers and medical professionals access and view collected data. For the validation of the platform, the investigators will recruit a total of 100 participants with and without cognitive impairment (50 subjects per group). Eligible subjects will undergo one week observational study while using the system at home. The investigators hypothesize that monitoring performance of IADLs, their timing, as well as other metrics like life space size and patterns of physical activity can discriminate between groups. Furthermore, the acceptability, perception of benefit, and ease of use of IADLSys will be assessed using a technology acceptance model questionnaire (TAM) adopted for tele-health applications
Age
50 - 95 years
Sex
ALL
Healthy Volunteers
Yes
Baylor College of Medicine
Houston, Texas, United States
Start Date
November 1, 2021
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2024
Last Updated
March 13, 2025
64
ACTUAL participants
IADLSys system
DIAGNOSTIC_TEST
Lead Sponsor
Bijan Najafi, PhD
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04123314