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An Innovative Platform for Objective Monitoring of Instrumental Activities of Daily Living

NCT05703490 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

IADLSys system

Subjects will receive IADLSys system which includes interactive tablet and 5 paired pTAGs (bluetooth sensors to attach to objects of interest at home). The pTAGs monitor activities of daily living to assess if they are being completed and communicate with the tablet to keep record of interactions. We anticipate IADLSys enables to distinguish between groups with and without cognitive impairment and determine the severity of cognitive impairment in the cognitive impaired group.

Sponsors & Collaborators

  • BioSensics

    collaborator INDUSTRY

  • Bijan Najafi, PhD

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05703490 on ClinicalTrials.gov