Deprescribing Anticholinergic and Sedative MedicationsPhase 4NCT05735379
Impact in Older Adults of Reducing Anticholinergic and Sedative Rx Burden on Physical Function Measured by Wearables
A Phase 4 study testing Deprescribing anticholinergic and sedative mediications in people with Deprescribing Anticholinergic and Sedative Medications and Physical Function, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Deprescribing Anticholinergic and Sedative Medications, Physical Function
- What is being tested?
- Deprescribing anticholinergic and sedative mediications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteCanada
- Study dates
- 23 Mar 2023to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, J1H 4C4
Marilyn Tousignant
About this study
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
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.
- Being tested
- Deprescribing anticholinergic and sedative mediications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deprescribing anticholinergic and sedative mediicationsDrug
Also called Drug cessation or dose reduction
Deprescribing plan targeting a reduction in Drug Burden Index score of ≥ 0.5
| Study group | Role | What they receive |
|---|---|---|
| Deprescribing anticholinergic and sedative medications | Experimental | Deprescribing plan targeting a reduction in drug burden index score of ≥ 0.5 Receives: Drug: Deprescribing anticholinergic and sedative mediications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait capacity measured in the lab from baseline to study completion
Gait speed (m/s)
Measured: 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
Gait activity (number of steps)
Measured: 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),
Measured: 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.
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 4 months.
Adverse drug events and adverse drug withdrawal events
Adverse anticholinergic and sedative effects from G-MEDSS
Measured: Continuous during the deprescribing process
Change in Montreal Cognitive Assessment (MoCA) from baseline to study completion
Full version
Measured: Through study completion, an average of 4 months.
Change in Trail Making Test (TMT) from baseline to study completion
Part A \& B
Measured: Through study completion, an average of 4 months.
Change in Digit Symbol Substitution Test from baseline to study completion
DSST
Measured: Through study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start23 Mar 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deprescribing Anticholinergic and Sedative MedicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benoit Cossette, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735379
- Sponsor's protocol ID
- PJT-183968
- Status last verified
- Sep 2023
- First submitted
- 26 Jan 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05735379
- Acronym / sponsor ID
- PJT-183968
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deprescribing anticholinergic and sedative medications | Experimental | Drug: Deprescribing anticholinergic and sedative mediicationsDeprescribing plan targeting a reduction in drug burden index score of ≥ 0.5 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deprescribing anticholinergic and sedative mediicationsAlso: Drug cessation or dose reductionDeprescribing plan targeting a reduction in Drug Burden Index score of ≥ 0.5 | Drug | Deprescribing anticholinergic and sedative medications |
Primary outcome
Change in gait capacity measured in the lab from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Gait speed (m/s)
9 secondary outcomes
Change in gait performance measured in real-life settings from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Change in functional limitations and disability from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Change in caregiver report of the patients' functional status from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Change in falls and near falls from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Change in falls and near falls from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Adverse drug events and adverse drug withdrawal events
Time frame: Continuous during the deprescribing process
Change in Montreal Cognitive Assessment (MoCA) from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Change in Trail Making Test (TMT) from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Change in Digit Symbol Substitution Test from baseline to study completion
Time frame: Through study completion, an average of 4 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deprescribing anticholinergic and sedative mediications in people with Deprescribing Anticholinergic and Sedative Medications and Physical Function, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marilyn Tousignant, MSc (819-780-2222, marilyn.tousignant@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.