Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05735379
Status:
RECRUITING
Last Update Posted:
2023-09-18
First Post:
2023-01-26
Brief Title:
Impact in Older Adults of Reducing Anticholinergic and Sedative Rx Burden on Physical Function Measured by Wearables
Sponsor:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Organization:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Overview
Official Title:
Impact in Older Adults of Reducing Anticholinergic and Sedative Medication Burden on Physical Function Measured by Clinical Digital Phenotyping in Lab and Real-life Environments
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Medications with sedative or anticholinergic effects such as antidepressants benzodiazepines or opioids have been associated with impaired cognitive and physical function They are referred to as potentially inappropriate medications or medications that are best avoided by older adults The accumulated evidence has now shifted the clinical and research focus to evaluating the who what and how of the best way to deprescribe ie dose reduction or cessation of these medications The Drug Burden Index DBI allows researchers and clinicians to quantify the cumulative burden of anticholinergic and sedative medications in each patient Deprescribing these medications is a complex health intervention based on trade-offs between their clinical benefits eg symptom management and prevention of diseases and their adverse drug events to improve physical and cognitive function Existing physical function performance metrics such as gait speed captured in the clinic are often non-specific and do not reflect real-life performance Innovative mobility metrics are required to better understand specific deficits with age and disease and the effects of medications on these deficits
The goal of this project is to better characterize the impact of reducing the anticholinergic and sedative medication burden on physical function in older adults by novel mobility metrics in lab and real-life environments
A prospective longitudinal cohort of 182 community-dwelling older adults 65 years with a DBI of 1 will be completed Using a quasi-experimental design recruited patients will undergo a medication deprescribing plan as part of usual clinical care that includes three gradual changes to their medication regimen resulting in three DBI levels At each DBI level physical function mobility including dual-task tests will be assessed in the lab with wearable sensors during validated clinical tests such as the Short Physical Performance Battery Objective balance and mobility metrics eg sway area and frequency stride length will be extracted Physical function will also be assessed continuously in the patients real-life environment from recruitment to the last lab visit using wearable Apple Watch with ankle inertial measurement unit and environmental sensors Cognition will be measured using the Montreal Cognitive Assessment Trail Making Test Part A B and Digit Symbol Substitution Test
The goal of this project is to better characterize the impact of reducing the anticholinergic and sedative medication burden on physical function in older adults by novel mobility metrics in lab and real-life environments
A prospective longitudinal cohort of 182 community-dwelling older adults 65 years with a DBI of 1 will be completed Using a quasi-experimental design recruited patients will undergo a medication deprescribing plan as part of usual clinical care that includes three gradual changes to their medication regimen resulting in three DBI levels At each DBI level physical function mobility including dual-task tests will be assessed in the lab with wearable sensors during validated clinical tests such as the Short Physical Performance Battery Objective balance and mobility metrics eg sway area and frequency stride length will be extracted Physical function will also be assessed continuously in the patients real-life environment from recruitment to the last lab visit using wearable Apple Watch with ankle inertial measurement unit and environmental sensors Cognition will be measured using the Montreal Cognitive Assessment Trail Making Test Part A B and Digit Symbol Substitution Test
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None