Longitudinal Analysis of Drug Burden Index

Completed

• Conditions: Cognitive Function; Polypharmacy; Hypnotics and Sedatives; Anticholinergics; Physical Function

• Registration Number: NCT03024541
• Lead Sponsor: University of Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-10-18
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-19
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9985

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LASA study: Alphabet Coding Task	21 years: 7 waves separated by 3 year intervals

Secondary Outcome Measures

Name	Time	Method
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: 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: Digit Span Forward from Wechsler Adult Intelligence Scale	collected at 7th wave after 21 years (cross-sectional)
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: Balance Test	21 years: 7 waves separated by 3 year intervals
LASA study: Verbal Fluency Test: Semantic fluency	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: Functional Independence Scale	18 years: 6 waves with 3 year intervals
LASA study: Cardigan Test	21 years: 7 waves separated by 3 year intervals