Clinical trial NCT05703490: An Innovative Platform for Objective Monitoring of Instrumental Activities of Daily Living
Official title: An Innovative Platform for Objective Monitoring of Instrumental Activities of Daily Living
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dementia
Cognitive Impairment
Alzheimer Disease
Keywords: dementia
activities of daily living
MCI
Telehealth
Smart home
IOT
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: BioSensics
First posted: 2023-01-30
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory older adults (over 50 years old) with and without cognitive impairment.

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

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

Primary outcomes:
measure: Medication adherence
timeFrame: 1 week
measure: Cognitive function
timeFrame: Baseline
Secondary outcomes:
measure: Changes in acceptability, perception of benefit, and ease of use of IADLSys System from baseline to follow up
timeFrame: baseline, 1 week
measure: History of fall
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
measure: Life Space
timeFrame: one week
measure: Adherence to physical activity monitoring from baseline to follow up
timeFrame: 1 week
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: 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.