Longitudinal Analysis of Drug Burden Index

Study Overview
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Brief Summary
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Anticholinergic and sedative drugs are frequently prescribed to older people, despite their negative impact on older people's physical and cognitive function. To estimate the cumulative exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index (DBI) in 2007. The present study aims to complement previous study findings showing higher DBI values to be associated with physical and cognitive impairment. Most previously conducted studies of the DBI were either cross-sectional or were longitudinal but with short follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for patients with dementia. Finally, relatively little is known about the stability of DBI values over time. The current project therefore aims to examine (1) longitudinal relationships between long-term cumulative exposure to anticholinergic and sedative drugs as measured with the DBI and cognitive and physical function, (2) to examine interaction effects between DBI exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure remaining stable, declining, increasing or fluctuating over time. These project aims will be studied with longitudinal data from eligible participants > 60 years from the LASA study with participants being followed-up during two decades, and the longitudinal data from the InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will be studied. Data will be analysed with generalised linear mixed models and Latent Class Growth Analysis.

Official Title
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Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index

Conditions
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Polypharmacy, Anticholinergics, Hypnotics and Sedatives, Cognitive Function, Physical Function

Participation Criteria
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Eligibility Criteria
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LASA: Inclusion criteria: 55 years and older Exclusion criteria: problem drinkers in the past and the present very severe vision and hearing problems InterRAI: Inclusion criteria: 55 years or older Exclusion criteria: consumption of 5 or more units of alcohol on one occasion unknown sex or age

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LASA study<br> | |
| InterRAI consortium<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LASA study: Alphabet Coding Task |  | 21 years: 7 waves separated by 3 year intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LASA study: Mini Mental Status Examination |  | 21 years: 7 waves separated by 3 year intervals | 
| LASA study: Verbal Fluency Test: Phonemic fluency |  | collected at 7th wave after 21 years (cross-sectional) | 
| LASA study: Verbal Fluency Test: Semantic fluency |  | collected at 7th wave after 21 years (cross-sectional) | 
| LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale |  | collected at 7th wave after 21 years (cross-sectional) | 
| LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale |  | collected at 7th wave after 21 years (cross-sectional) | 
| LASA study: 15-Words Test: Word Learning |  | 21 years: 7 waves separated by 3 year intervals | 
| LASA study: 15-Words Test: Delayed Recall |  | 21 years: 7 waves separated by 3 year intervals | 
| LASA study: Functional Independence Scale |  | 18 years: 6 waves with 3 year intervals | 
| LASA study: Chair Stands Test |  | 21 years: 7 waves separated by 3 year intervals | 
| LASA study: Walking Test |  | 21 years: 7 waves separated by 3 year intervals | 
| LASA study: Cardigan Test |  | 21 years: 7 waves separated by 3 year intervals | 
| LASA study: Balance Test |  | 21 years: 7 waves separated by 3 year intervals |