Longitudinal Analysis of Drug Burden Index

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 9985

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People aged 55 years and older, both community-dwelling individuals and individuals living in residential aged care facilities

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LASA study
InterRAI consortium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
InterRAI: Cognitive Performance Scale	16 months
InterRAI: ADL Hierarchy Scale	16 months
InterRAI: Timed 4 meter Walk Test	16 months
InterRAI: Distance walked in past 3 days	16 months
InterRAI: Hours of physical activity in past 3 days	16 months
InterRAI: Days of coming outside in past 3 days	16 months

Collaborators and Investigators

• Sponsor: University of Groningen

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Estimate): January 19, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DBI InterRAI LASA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not Applicable: Permission to use the data should be obtained from the LASA and/or InterRAI researchers