← Back to all trials
Recruiting
NCT05703490
An Innovative Platform for Objective Monitoring of Instrumental Activities of Daily Living
Conditions: Dementia, Cognitive Impairment, Alzheimer Disease
Sex: All
Ages: 50 Years – 95 Years
Healthy volunteers: 1
Enrollment: 100
Sponsor: Bijan Najafi, PhD
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:50 years or olderAmbulatory and are living independently in a residential home with a caregiver/informantWilling and able to provide informed consentExclusion Criteria:Under 50 yearsimmobility or inability to engage in IADL that are essential for independent livingPatients with any clinically significant medical or psychiatric conditionRecent stroke over last 6 monthsmajor hearing/visual impairmentany acute diagnosis that may impact IADL (e.g., fracture, foot ulcer, recent surgery, etc)residing in a nursing home or are receiving hospice careinability to communicate in Englishare unlikely to fully comply with the follow-up protocol
Source: ClinicalTrials.gov (NCT05703490). StuddyBuddy aggregates publicly available trial information.