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

NCT05703490 | Terminated

• 1 other identifier: H-43413
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Cognitive Impairment; Alzheimer Disease

Keywords

dementia; activities of daily living; MCI; Telehealth; Smart home; IOT

Outcome Measures

Primary Outcomes (2)

• Medication adherence

  Medication adherence is assessed by self-report as well as IADLSys

  1 week

• 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 Outcomes (5)

• Changes in acceptability, perception of benefit, and ease of use of IADLSys System from baseline to follow up

  baseline, 1 week

• History of fall

  Baseline

• Depression

  Baseline

• Life Space

  one week

• Adherence to physical activity monitoring from baseline to follow up

  1 week

Study Arms (2)

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

Diagnostic Test: IADLSys system

Cognitive Intact Group

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

Diagnostic Test: IADLSys system

Interventions

IADLSys system 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 Impaired Group; Cognitive Intact Group

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory older adults (over 50 years old) with and without cognitive impairment.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bijan Najafi, PhD: lead
• BioSensics: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related 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 Cognitive Impairment: A Proof of Concept and Feasibility Study. Sensors (Basel). 2022 Sep 7;22(18):6745. doi: 10.3390/s22186745.

  PMID: 36146095 BACKGROUND

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: January 30, 2023
• Study Start: November 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)