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

NCT ID: NCT05735379

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deprescribing anticholinergic and sedative medications

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

Group Type: EXPERIMENTAL

Deprescribing anticholinergic and sedative mediications

Intervention Type: DRUG

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

Interventions

Deprescribing anticholinergic and sedative mediications

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

Intervention Type: DRUG

Other Intervention Names

Drug cessation or dose reduction

Eligibility Criteria

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Benoit Cossette

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marilyn Tousignant, MSc

Role: CONTACT

marilyn.tousignant@usherbrooke.ca

819-780-2222

Facility Contacts

Marilyn Tousignant

Role: primary

Other Identifiers

PJT-183968

Identifier Type: -

Identifier Source: org_study_id