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Longitudinal Analysis of Drug Burden Index

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03024541
Enrollment
9985
Registered
2017-01-19
Start date
2016-06-30
Completion date
2016-06-30
Last updated
2017-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

University of Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
LASA study: Alphabet Coding Task21 years: 7 waves separated by 3 year intervals

Secondary

MeasureTime frame
LASA study: Digit Span Forward from Wechsler Adult Intelligence Scalecollected at 7th wave after 21 years (cross-sectional)
LASA study: 15-Words Test: Delayed Recall21 years: 7 waves separated by 3 year intervals
LASA study: Functional Independence Scale18 years: 6 waves with 3 year intervals
LASA study: Chair Stands Test21 years: 7 waves separated by 3 year intervals
LASA study: Walking Test21 years: 7 waves separated by 3 year intervals
LASA study: Cardigan Test21 years: 7 waves separated by 3 year intervals
LASA study: Balance Test21 years: 7 waves separated by 3 year intervals
LASA study: Mini Mental Status Examination21 years: 7 waves separated by 3 year intervals
LASA study: Verbal Fluency Test: Phonemic fluencycollected at 7th wave after 21 years (cross-sectional)
LASA study: Verbal Fluency Test: Semantic fluencycollected at 7th wave after 21 years (cross-sectional)
LASA study: Digit Span Backward from Wechsler Adult Intelligence Scalecollected at 7th wave after 21 years (cross-sectional)
LASA study: 15-Words Test: Word Learning21 years: 7 waves separated by 3 year intervals

Other

MeasureTime frame
InterRAI: Timed 4 meter Walk Test16 months
InterRAI: Distance walked in past 3 days16 months
InterRAI: Hours of physical activity in past 3 days16 months
InterRAI: Days of coming outside in past 3 days16 months
InterRAI: ADL Hierarchy Scale16 months
InterRAI: Cognitive Performance Scale16 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026