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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05703490
• Other study ID #: H-43413
• Status: Active, not recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Impairment
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bijan Najafi, PhD	BioSensics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	Medication adherence is assessed by self-report as well as IADLSys	1 week
Primary	Cognitive function	Cognitive function is assessed by Montreal Cognitive Assessment (MoCA) Test. A score of 26 or lower is considered as cognitive impaired.	Baseline
Secondary	Changes in acceptability, perception of benefit, and ease of use of IADLSys System from baseline to follow up	Acceptability, perception of benefit, and ease of use will be assessed using Technology Acceptance Model questionnaire (TAM) adopted for tele-health applications. Initial opinions and scores from baseline will be compared to the answers at 1 week follow up.	baseline, 1 week
Secondary	History of fall	Self report history of falls will be documented at baseline	Baseline
Secondary	Depression	Depression is assessed by Center for Epidemiologic Studies Depression Scale (CES-D). Score ranges from 0 to 60, higher the score indicates presence of depression.	Baseline
Secondary	Life Space	The Life Space Questionnaire is a measure of the extent of mobility of older adults. Score ranges from 0-9, with higher score indicating the particpant uses more of their space regularly.	one week
Secondary	Adherence to physical activity monitoring from baseline to follow up	Adherence to physical activity monitoring by wearing a validated pendant sensor from baseline to 1 week will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done for 1 week from baseline to 1 week follow up.	1 week