Clinical trial NCT05735379: Impact in Older Adults of Reducing Anticholinergic and Sedative Rx Burden on Physical Function Measured by Wearables
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Deprescribing Anticholinergic and Sedative Medications
Physical Function
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 182
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in gait capacity measured in the lab from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
Secondary outcomes:
measure: Change in gait performance measured in real-life settings from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
measure: Change in functional limitations and disability from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
measure: Change in caregiver report of the patients' functional status from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
measure: Change in falls and near falls from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
measure: Change in falls and near falls from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
measure: Adverse drug events and adverse drug withdrawal events
timeFrame: Continuous during the deprescribing process
measure: Change in Montreal Cognitive Assessment (MoCA) from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
measure: Change in Trail Making Test (TMT) from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
measure: Change in Digit Symbol Substitution Test from baseline to study completion
timeFrame: Through study completion, an average of 4 months.
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-CHUS
state: Quebec
Study officials:
References: