Clinical trial NCT03024541: Longitudinal Analysis of Drug Burden Index
Official title: Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polypharmacy
Anticholinergics
Hypnotics and Sedatives
Cognitive Function
Physical Function
Lead sponsor: University of Groningen
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 9985
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People aged 55 years and older, both community-dwelling individuals and individuals living in residential aged care facilities

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.


Eligibility 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

Exclusion criteria:

* consumption of 5 or more units of alcohol on one occasion
* unknown sex or age

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