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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Marilyn Tousignant, MSc contact

819-780-2222

marilyn.tousignant@usherbrooke.ca

Canada1 site, 1 recruiting
  • CIUSSS de l'Estrie-CHUS

    Sherbrooke, Quebec, J1H 4C4

    Marilyn Tousignant

    Recruiting

Other trials in Canada

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 groups in NCT05735379
Study groupRoleWhat they receive
Deprescribing anticholinergic and sedative medicationsExperimentalDeprescribing 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Adverse drug events and adverse drug withdrawal events

    Adverse anticholinergic and sedative effects from G-MEDSS

    Measured: Continuous during the deprescribing process

  7. Change in Montreal Cognitive Assessment (MoCA) from baseline to study completion

    Full version

    Measured: Through study completion, an average of 4 months.

  8. Change in Trail Making Test (TMT) from baseline to study completion

    Part A \& B

    Measured: Through study completion, an average of 4 months.

  9. 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.

  1. First posted21 Feb 2023
  2. Study start23 Mar 2023
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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