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临床试验/NCT05735379
NCT05735379招募中4 期

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

Centre de recherche du Centre hospitalier universitaire de Sherbrooke1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2023年3月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
182
试验地点
1
主要终点
Change in gait capacity measured in the lab from baseline to study completion

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Need of a walker as a mobility assistive device
  • Unstable medical condition (≥ 1 unplanned hospitalization or ≥ 2 emergency department visits in the past month).

研究组 & 干预措施

Deprescribing anticholinergic and sedative medications

Experimental

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

干预措施: Deprescribing anticholinergic and sedative mediications (Drug)

结局指标

主要结局

Change in gait capacity measured in the lab from baseline to study completion

时间窗: Through study completion, an average of 4 months.

Gait speed (m/s)

次要结局

  • Change in Trail Making Test (TMT) from baseline to study completion(Through study completion, an average of 4 months.)
  • Change in Digit Symbol Substitution Test from baseline to study completion(Through study completion, an average of 4 months.)
  • Adverse drug events and adverse drug withdrawal events(Continuous during the deprescribing process)
  • Change in Montreal Cognitive Assessment (MoCA) from baseline to study completion(Through study completion, an average of 4 months.)
  • Change in gait performance measured in real-life settings from baseline to study completion(Through study completion, an average of 4 months.)
  • Change in functional limitations and disability from baseline to study completion(Through study completion, an average of 4 months.)
  • Change in falls and near falls from baseline to study completion(Through study completion, an average of 4 months.)
  • Change in caregiver report of the patients' functional status from baseline to study completion(Through study completion, an average of 4 months.)

研究者

发起方
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benoit Cossette

Professor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

研究点 (1)

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