NCT05961319

Brief Summary

This project aims to address the impact of frailty on older adults, particularly its connection to cognitive impairments such as dementia. By identifying frailty in its early stages, interventions can be designed to slow down the progression of cognitive decline. To achieve this, the project plans to develop a reliable at-home monitoring system that can accurately track frailty in older adults with mild cognitive impairment or dementia. By utilizing cutting-edge technologies such as high-precision indoor positioning and home-installed sensors, referred to as zero-effort technologies (ZETs), the system will collect continuous sensor data, which will be analyzed to identify indicators of frailty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

June 26, 2023

Last Update Submit

August 21, 2024

Conditions

Keywords

FrailFrailtyPre-FrailAssessmentMonitoringHomeHouseSmartTechnologyTechnologicalSensorsTracking

Outcome Measures

Primary Outcomes (8)

  • Slowness (Mobility)

    15 Foot Walk / 5 Metres, Timed. The sensors and the camera will record the participants' data during this time.

    through study completion, within a total average of 2 hours

  • Weight (lbs, Kgs)

    Weight taken using an internet of things scale

    through study completion, within a total average of 2 hours

  • Exhaustion

    Smart speaker delivered two questions from the Center for Epidemiological Studies-Depression (CES-D) scale (7. I felt that everything I did was an Effort, 20. I could not get "going."). The sensors and the camera will record the participants' data during this time.

    through study completion, within a total average of 2 hours

  • Strength - Handgrip

    Using a internet of things dynanometer, force will be assessed (3 times each hand - 30 seconds of rest between measurements) and to release it. The sensors and the camera will record the participants' data during this time.

    through study completion, within a total average of 2 hours

  • Activity

    The participant is asked to complete two tasks from the Performance Assessment of Self-Care Skills (PASS - Clinic) Version 4.1. This will involve a simulated version of carrying garbage, and sweeping the floors. The sensors and the camera will record the participants' data during this time.

    through study completion, within a total average of 2 hours

  • Meal Preparation

    Participants will be asked to prepare a simple sandwich using the kitchen elements.The sensors and the camera will record the participants' data during this time.

    through study completion, within a total average of 2 hours

  • Observe Free Activity

    During the data collection, participants will be given 5 minutes to do whatever activity they want. The sensors and the camera will record the participants' data during this time.

    through study completion, within a total average of 2 hours

  • Qualitative Interviews Regarding Technology

    Qualitative Interview (Based on the Unified Theory of Acceptance and Use of Technology (UTAUT) constructs)

    Through study completion, within a total average of 2 hours

Study Arms (1)

Utilizing Smart Home Monitoring System in a Simulated Home Environment (in Hospital)

The project involves recruiting participants who will reside in a simulated condo environment within the Glenrose Rehabilitation Hospital. These participants will be remotely monitored using various sensors, including ones that track their interactions with appliances and furniture, smart biomechanics devices that assess their physical balance and strength, and a positioning system. By collecting and analyzing data from these sensors, the project aims to gain insights into the participants' daily activities, functional abilities, physical condition, and spatial behaviour.

Device: Smart-Home Monitoring

Interventions

During the study, various sensors will be employed to capture participant interactions with appliances and furniture. These sensors may include: Interaction Sensors: These sensors are designed to recognize users' interactions with appliances and furniture within the smart environment. Smart Biomechanics Devices: Devices such as a Fitbit device an internet of Things grip Dynamometer will be utilized to assess physical balance and strength. Positioning System using Ultra-Wide Band (UWB) Technology: This positioning system leverages UWB technology, enabling furniture-level accuracies in interpreting self-care activities. As participants engage with different elements of the smart environment, these sensors will collect data. Additionally, participants will be recorded via video to further enhance the observational data captured during the study.

Utilizing Smart Home Monitoring System in a Simulated Home Environment (in Hospital)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older aged adults (60+ years old), with or without frailty, and with or without mild cognitive impairment (MCI).

You may qualify if:

  • In-patients at the Glenrose Rehabilitation Hospital (GRH) and GRH' visitors or staff (e.g. patients' caregivers, relatives, friends of older adults in-patient or staff at the GRH who are interested in participating) who are 65 years old or older
  • For in-patients who are pre-frail or frail according to the scale used at the GRH (can be equivalent to Fried's scale pre-frail/frail (score = 1 - 4). For GRH's visitors or staff, are robust according to Fried's Frail Scale (score=0) as per the definition in (Fried, 2001)
  • With or without some level of cognitive impairment (Standardized mini-mental state examination (MMSE) of 21 to 30 ("mild" (24-21) to "could be normal" (25-30)) or the equivalent in the screening tool.
  • Have a cognitive ability to interact with the frailty sensors (i.e. scale, dynamometer, smart speaker).
  • Have a functional vision and hearing with or without aides (glasses/hearing aids) to be able to interact with furniture and sensors at the ILS and to fill out questionnaires.
  • Have functional upper extremity function to be able to interact with furniture and sensors at the ILS.
  • Be able to walk independently 15 meters with or without a walking aid.
  • If taking antidepressants or narcotics, participants have no changes in the medication for at least 3 months

You may not qualify if:

  • Those with a history of Parkinson's disease or other movement disorders or stroke.
  • Justification: Movement disorders causing tremors will affect data collection by the sensors
  • Those who were taking Sinemet or Aricept
  • Older adults who have Influenza, long Covid-19 or another virus that affect their performance
  • Unable to count, speak (name objects and say numbers) or comprehend simple instructions in English
  • Have severe cardiac or respiratory diseases that prevent them to perform vigorous activities
  • Using supplemental oxygen (i.e., must be able to breathe with room air)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

Corbett Hall, University of Alberta

Edmonton, Alberta, T5G2H6, Canada

Location

Related Publications (5)

  • Lewinsohn PM, Seeley JR, Roberts RE, Allen NB. Center for Epidemiologic Studies Depression Scale (CES-D) as a screening instrument for depression among community-residing older adults. Psychol Aging. 1997 Jun;12(2):277-87. doi: 10.1037//0882-7974.12.2.277.

    PMID: 9189988BACKGROUND
  • Chisholm D, Toto P, Raina K, Holm M, Rogers J. Evaluating capacity to live independently and safely in the community: Performance Assessment of Self-care Skills. Br J Occup Ther. 2014 Feb;77(2):59-63. doi: 10.4276/030802214X13916969447038.

    PMID: 25298616BACKGROUND
  • Venkatesh, V., Morris, M. G., Davis, G. B., & Davis, F. D. (2003). User Acceptance of Information Technology: Toward a Unified View. MIS Quarterly, 27(3), 425-478. https://doi.org/10.2307/30036540

    BACKGROUND
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND
  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jim Raso, MASc

    Alberta Health services

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 27, 2023

Study Start

September 20, 2023

Primary Completion

March 20, 2024

Study Completion

June 30, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations