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

NCT ID: NCT05703490

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

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

Conditions

Dementia; Cognitive Impairment; Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cognitive Impaired Group

older adults (age 50 years and older) with either clinical diagnosis of cognitive impairment or determined to have cognitive impairment based on Montreal Cognitive Assessment (MoCA) Test, score of 26 or lower

IADLSys system

Intervention Type: DIAGNOSTIC_TEST

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.

Cognitive Intact Group

Older adults age matched with Cognitive Impaired Group with MoCA score of greater than 26

IADLSys system

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 50 years or older
• Ambulatory and are living independently in a residential home with a caregiver/informant
• Willing and able to provide informed consent

Exclusion Criteria

• Under 50 years
• immobility or inability to engage in IADL that are essential for independent living
• Patients with any clinically significant medical or psychiatric condition
• Recent stroke over last 6 months
• major hearing/visual impairment
• any acute diagnosis that may impact IADL (e.g., fracture, foot ulcer, recent surgery, etc)
• residing in a nursing home or are receiving hospice care
• inability to communicate in English
• are unlikely to fully comply with the follow-up protocol

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioSensics

INDUSTRY

Sponsor Role: collaborator

Bijan Najafi, PhD

OTHER

Sponsor Role: lead

Responsible Party

Bijan Najafi, PhD

Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

Lee M, Mishra RK, Momin A, El-Refaei N, Bagheri AB, York MK, Kunik ME, Derhammer M, Fatehi B, Lim J, Cole R, Barchard G, Vaziri A, Najafi B. Smart-Home Concept for Remote Monitoring of Instrumental Activities of Daily Living (IADL) in Older Adults with Cognitive Impairment: A Proof of Concept and Feasibility Study. Sensors (Basel). 2022 Sep 7;22(18):6745. doi: 10.3390/s22186745.

Reference Type: BACKGROUND

PMID: 36146095 (View on PubMed)

Other Identifiers

H-43413

Identifier Type: -

Identifier Source: org_study_id