Longitudinal Analysis of Drug Burden Index

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024541
• Other study ID #: DBI InterRAI LASA
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: January 13, 2017
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: University of Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9985
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	InterRAI: Cognitive Performance Scale		16 months
Other	InterRAI: ADL Hierarchy Scale		16 months
Other	InterRAI: Timed 4 meter Walk Test		16 months
Other	InterRAI: Distance walked in past 3 days		16 months
Other	InterRAI: Hours of physical activity in past 3 days		16 months
Other	InterRAI: Days of coming outside in past 3 days		16 months
Primary	LASA study: Alphabet Coding Task		21 years: 7 waves separated by 3 year intervals
Secondary	LASA study: Mini Mental Status Examination		21 years: 7 waves separated by 3 year intervals
Secondary	LASA study: Verbal Fluency Test: Phonemic fluency		collected at 7th wave after 21 years (cross-sectional)
Secondary	LASA study: Verbal Fluency Test: Semantic fluency		collected at 7th wave after 21 years (cross-sectional)
Secondary	LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale		collected at 7th wave after 21 years (cross-sectional)
Secondary	LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale		collected at 7th wave after 21 years (cross-sectional)
Secondary	LASA study: 15-Words Test: Word Learning		21 years: 7 waves separated by 3 year intervals
Secondary	LASA study: 15-Words Test: Delayed Recall		21 years: 7 waves separated by 3 year intervals
Secondary	LASA study: Functional Independence Scale		18 years: 6 waves with 3 year intervals
Secondary	LASA study: Chair Stands Test		21 years: 7 waves separated by 3 year intervals
Secondary	LASA study: Walking Test		21 years: 7 waves separated by 3 year intervals
Secondary	LASA study: Cardigan Test		21 years: 7 waves separated by 3 year intervals
Secondary	LASA study: Balance Test		21 years: 7 waves separated by 3 year intervals