Impact in Older Adults of Reducing Anticholinergic and Sedative Rx Burden on Physical Function Measured by Wearables

Physical Function Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735379
• Other study ID #: PJT-183968
• Status: Recruiting
• Phase: Phase 4
• Start date: March 23, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: Marilyn Tousignant, MSc
• Phone: 819-780-2222
• Email: marilyn.tousignant[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (i.e., 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 (e.g., 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 (e.g., sway area and frequency, stride length) will be extracted. Physical function will also be assessed continuously in the patient's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 65 years and older

• community-dwelling

• Drug Burden Index score of = 1

• Agree with a deprescribing plan targeting a reduction in Drug Burden Index score of = 0.5.

Exclusion Criteria:

• Dementia

• Need of a walker as a mobility assistive device

• Unstable medical condition (= 1 unplanned hospitalization or = 2 emergency department visits in the past month).

Related Conditions & MeSH terms

• Physical Function

Intervention

Drug:
• Deprescribing anticholinergic and sedative mediications
Deprescribing plan targeting a reduction in Drug Burden Index score of = 0.5

Locations

Country	Name	City	State
Canada	CIUSSS de l'Estrie-CHUS	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait capacity measured in the lab from baseline to study completion	Gait speed (m/s)	Through study completion, an average of 4 months.
Secondary	Change in gait performance measured in real-life settings from baseline to study completion	Gait activity (number of steps)	Through study completion, an average of 4 months.
Secondary	Change in functional limitations and disability from baseline to study completion	Late-Life Function and Disability Instrument (Late-Life FDI),	Through study completion, an average of 4 months.
Secondary	Change in caregiver report of the patients' functional status from baseline to study completion	Older Adults Resources and Services (OARS) Multidimensional Functional Assessment Questionnaire adapted for the caregiver.	Through study completion, an average of 4 months.
Secondary	Change in falls and near falls from baseline to study completion	Falls nand near falls recorded by patient diary	Through study completion, an average of 4 months.
Secondary	Change in falls and near falls from baseline to study completion	Falls and near falls recorded from the Apple Watch® proprietary algorithm.	Through study completion, an average of 4 months.
Secondary	Adverse drug events and adverse drug withdrawal events	Adverse anticholinergic and sedative effects from G-MEDSS	Continuous during the deprescribing process
Secondary	Change in Montreal Cognitive Assessment (MoCA) from baseline to study completion	Full version	Through study completion, an average of 4 months.
Secondary	Change in Trail Making Test (TMT) from baseline to study completion	Part A & B	Through study completion, an average of 4 months.
Secondary	Change in Digit Symbol Substitution Test from baseline to study completion	DSST	Through study completion, an average of 4 months.