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

NCT05735379 | Unknown Phase 4

• 1 other identifier: PJT-183968
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Deprescribing Anticholinergic and Sedative Medications; Physical Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in gait performance measured in real-life settings from baseline to study completion

  Through study completion, an average of 4 months.

• Change in functional limitations and disability from baseline to study completion

  Through study completion, an average of 4 months.

• Change in caregiver report of the patients' functional status from baseline to study completion

  Through study completion, an average of 4 months.

• Change in falls and near falls from baseline to study completion

  Through study completion, an average of 4 months.

• Change in falls and near falls from baseline to study completion

  Through study completion, an average of 4 months.

Study Arms (1)

Deprescribing anticholinergic and sedative medications

EXPERIMENTAL

Deprescribing plan targeting a reduction in drug burden index score of ≥ 0.5

Drug: Deprescribing anticholinergic and sedative mediications

Interventions

Deprescribing anticholinergic and sedative mediications DRUG

Deprescribing plan targeting a reduction in Drug Burden Index score of ≥ 0.5

Also known as: Drug cessation or dose reduction

Deprescribing anticholinergic and sedative medications

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, J1H 4C4, Canada

RECRUITING

MeSH Terms

Interventions

Drug Tapering

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Marilyn Tousignant, MSc

CONTACT

819-780-2222; marilyn.tousignant@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 21, 2023
• Study Start: March 23, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

CA (1)