Longitudinal Analysis of Drug Burden Index

NCT03024541 | Completed

• 1 other identifier: DBI InterRAI LASA
• Study Type: observational
• Target: 9,985
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polypharmacy; Anticholinergics; Hypnotics and Sedatives; Cognitive Function; Physical Function

Outcome Measures

Primary Outcomes (1)

• LASA study: Alphabet Coding Task

  21 years: 7 waves separated by 3 year intervals

Secondary Outcomes (12)

• 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)

Other Outcomes (6)

• InterRAI: Cognitive Performance Scale

  16 months

• InterRAI: ADL Hierarchy Scale

  16 months

• InterRAI: Timed 4 meter Walk Test

  16 months

Study Arms (2)

LASA study

InterRAI consortium

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years and older

You may not qualify if:

• problem drinkers in the past and the present
• very severe vision and hearing problems
• InterRAI:
• years or older
• consumption of 5 or more units of alcohol on one occasion
• unknown sex or age

Sponsors & Collaborators

• University of Groningen: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: January 19, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01