Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05961319
Other study ID # Pro00131722
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 20, 2023
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 21
Est. completion date June 30, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Study Design


Intervention

Device:
Smart-Home Monitoring
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.

Locations

Country Name City State
Canada Corbett Hall, University of Alberta Edmonton Alberta
Canada Glenrose Rehabilitation Hospital Edmonton Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Alberta Alberta Health services, Glenrose Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Weight (lbs, Kgs) Weight taken using an internet of things scale through study completion, within a total average of 2 hours
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1