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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Function; Deprescribing Anticholinergic and Sedative Medications
• Intervention / Treatment: Drug: Deprescribing anticholinergic and sedative mediications

• Study Type: Interventional
• Enrollment (Estimated): 182
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Marilyn Tousignant, MSc; Phone Number: 819-780-2222; Email: marilyn.tousignant@usherbrooke.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Recruiting
      • CIUSSS de l'Estrie-CHUS
      • Contact: Marilyn Tousignant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deprescribing anticholinergic and sedative medications; Deprescribing plan targeting a reduction in drug burden index score of ≥ 0.5	Drug: Deprescribing anticholinergic and sedative mediications; Deprescribing plan targeting a reduction in Drug Burden Index score of ≥ 0.5; Other Names: Drug cessation or dose reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
Adverse drug events and adverse drug withdrawal events	Adverse anticholinergic and sedative effects from G-MEDSS	Continuous during the deprescribing process
Change in Montreal Cognitive Assessment (MoCA) from baseline to study completion	Full version	Through study completion, an average of 4 months.
Change in Trail Making Test (TMT) from baseline to study completion	Part A & B	Through study completion, an average of 4 months.
Change in Digit Symbol Substitution Test from baseline to study completion	DSST	Through study completion, an average of 4 months.

Collaborators and Investigators

• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Cholinergic Agents; Hypnotics and Sedatives; Cholinergic Antagonists
• Other Study ID Numbers: PJT-183968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No