Recruiting

Observational Study

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT05735379

Conditions

Deprescribing Anticholinergic and Sedative Medications

Physical Function

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Deprescribing anticholinergic and sedative mediications

Study Details

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 ID

NCT05735379

Start date

Mar 23, 2023

Status verified date

Sep, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

182 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Deprescribing anticholinergic and sedative medications

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

Primary outcome measure

  • Change in gait capacity measured in the lab from baseline to study completion [ Time Frame: Through study completion, an average of 4 months. ]

Central Contacts and Locations

Central contacts

Locations

CIUSSS de l'Estrie-CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 4C4

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

Sep 18, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2023-09-18.