FrailtyNCT05961319
Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
An observational study of Frailty and Frailty Syndrome, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Frailty Syndrome, Frail Elderly Syndrome
- What is being tested?
- Smart-Home Monitoring
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Sep 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older aged adults (60+ years old), with or without frailty, and with or without mild cognitive impairment (MCI).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Corbett Hall, University of Alberta
Edmonton, Alberta, T5G2H6
About this study
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.
Read the detailed description
This project is centred around addressing the impact of frailty on older adults and its correlation with cognitive impairments, particularly dementia. The aim is to develop an effective and non-intrusive at-home monitoring system that can accurately track frailty in older adults with mild cognitive impairment or dementia. By identifying frailty in its early stages, interventions can be designed to slow down the progression of cognitive decline and improve the overall well-being of older adults.
To achieve this, the project plans to leverage cutting-edge technologies such as high-precision indoor positioning and home-installed sensors, collectively referred to as zero-effort technologies (ZETs). These technologies require minimal user effort and will provide a continuous stream of sensor data. The collected data will be systematically analyzed to identify indicators of frailty, allowing for early detection and intervention. Importantly, the project recognizes the significance of engaging older adults, caregivers, and healthcare professionals throughout the development process. Their attitudes, beliefs, and perceptions will be taken into consideration to ensure that the monitoring system is meaningful, beneficial, and respects user privacy.
By involving older adults and caregivers in the early stages, the project aims to create a monitoring system that can be seamlessly integrated into the lives of older adults dealing with frailty and cognitive impairments. The goal is to provide an affordable and efficient solution that can be implemented within the comfort and familiarity of their own homes. The continuous tracking of frailty data will enable healthcare professionals and caregivers to deliver timely interventions and support, thereby potentially slowing down the cognitive decline experienced by older adults.
Through the combination of advanced technologies and a user-centred approach, the project intends to bridge the gap between frailty and cognitive impairments in older adults. By identifying frailty at an early stage and tailoring interventions accordingly, personalized and targeted support can be provided to improve the quality of life for older adults with mild cognitive impairment or dementia. Ultimately, the project aims to contribute to the development of effective strategies for managing frailty and cognitive decline, benefiting both older adults and their caregivers, as well as clinicians.
- Conditions
- Frailty, Frailty Syndrome, Frail Elderly Syndrome, Pre-Frailty, Healthy, Healthy Aging
- Being tested
- Smart-Home Monitoring
- Keywords
- Frail, Frailty, Pre-Frail, Assessment, Monitoring, Home, House, Smart, Technology, Technological, Sensors, Tracking
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart-Home MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smart-Home Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slowness (Mobility)
15 Foot Walk / 5 Metres, Timed. The sensors and the camera will record the participants' data during this time.
Measured: through study completion, within a total average of 2 hours
Weight (lbs, Kgs)
Weight taken using an internet of things scale
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Through study completion, within a total average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start20 Sep 2023
- Primary completion20 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, Glenrose Foundation
- Responsible party
- Sponsor
- Investigators
- Jim Raso, MASc, Study chair, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961319
- Sponsor's protocol ID
- Pro00131722
- Status last verified
- Aug 2024
- First submitted
- 26 Jun 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9189988Chisholm 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.
PubMed 25298616Venkatesh, 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
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.
PubMed 11253156Folstein 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.
PubMed 1202204
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
- ClinicalTrials.gov ID
- NCT05961319
- Acronym / sponsor ID
- Pro00131722
- Conditions
- Frailty, Frailty Syndrome, Frail Elderly Syndrome, Pre-Frailty, Healthy, Healthy Aging
- Keywords
- Frail, Frailty, Pre-Frail, Assessment, Monitoring, Home, House, Smart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services, Glenrose Foundation
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project is centred around addressing the impact of frailty on older adults and its correlation with cognitive impairments, particularly dementia. The aim is to develop an effective and non-intrusive at-home monitoring system that can accurately track frailty in older adults with mild cognitive impairment or dementia. By identifying frailty in its early stages, interventions can be designed to slow down the progression of cognitive decline and improve the overall well-being of older adults.
To achieve this, the project plans to leverage cutting-edge technologies such as high-precision indoor positioning and home-installed sensors, collectively referred to as zero-effort technologies (ZETs). These technologies require minimal user effort and will provide a continuous stream of sensor data. The collected data will be systematically analyzed to identify indicators of frailty, allowing for early detection and intervention. Importantly, the project recognizes the significance of engaging older adults, caregivers, and healthcare professionals throughout the development process. Their attitudes, beliefs, and perceptions will be taken into consideration to ensure that the monitoring system is meaningful, beneficial, and respects user privacy.
By involving older adults and caregivers in the early stages, the project aims to create a monitoring system that can be seamlessly integrated into the lives of older adults dealing with frailty and cognitive impairments. The goal is to provide an affordable and efficient solution that can be implemented within the comfort and familiarity of their own homes. The continuous tracking of frailty data will enable healthcare professionals and caregivers to deliver timely interventions and support, thereby potentially slowing down the cognitive decline experienced by older adults.
Through the combination of advanced technologies and a user-centred approach, the project intends to bridge the gap between frailty and cognitive impairments in older adults. By identifying frailty at an early stage and tailoring interventions accordingly, personalized and targeted support can be provided to improve the quality of life for older adults with mild cognitive impairment or dementia. Ultimately, the project aims to contribute to the development of effective strategies for managing frailty and cognitive decline, benefiting both older adults and their caregivers, as well as clinicians.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utilizing Smart Home Monitoring System in a Simulated Home Environment (in Hospital) | – | Device: Smart-Home MonitoringThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older aged adults (60+ years old), with or without frailty, and with or without mild cognitive impairment (MCI).
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart-Home MonitoringDuring 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. | Device | Utilizing Smart Home Monitoring System in a Simulated Home Environment (in Hospital) |
Primary outcome
Slowness (Mobility)
Time frame: through study completion, within a total average of 2 hours
15 Foot Walk / 5 Metres, Timed. The sensors and the camera will record the participants' data during this time.
Weight (lbs, Kgs)
Time frame: through study completion, within a total average of 2 hours
Weight taken using an internet of things scale
Exhaustion
Time frame: through study completion, within a total average of 2 hours
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.
Strength - Handgrip
Time frame: through study completion, within a total average of 2 hours
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.
Activity
Time frame: through study completion, within a total average of 2 hours
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.
Meal Preparation
Time frame: through study completion, within a total average of 2 hours
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.
Observe Free Activity
Time frame: through study completion, within a total average of 2 hours
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.
Qualitative Interviews Regarding Technology
Time frame: Through study completion, within a total average of 2 hours
Qualitative Interview (Based on the Unified Theory of Acceptance and Use of Technology (UTAUT) constructs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Background: PubMed 9189988Lewinsohn 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.
- Background: PubMed 25298616Chisholm 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.
- BackgroundVenkatesh, 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: PubMed 11253156Fried 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.
- Background: PubMed 1202204Folstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Raso, MASc study chair
Alberta Health services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Frailty Syndrome, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slowness (Mobility) (time frame: through study completion, within a total average of 2 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961319, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.