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Completed

NCT Number: NCT03024541

Longitudinal Analysis of 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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. LASA study: Alphabet Coding Task

    Time frame: 21 years: 7 waves separated by 3 year intervals

Secondary outcomes

  1. LASA study: Mini Mental Status Examination

    Time frame: 21 years: 7 waves separated by 3 year intervals

  2. LASA study: Verbal Fluency Test: Phonemic fluency

    Time frame: collected at 7th wave after 21 years (cross-sectional)

  3. LASA study: Verbal Fluency Test: Semantic fluency

    Time frame: collected at 7th wave after 21 years (cross-sectional)

  4. LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale

    Time frame: collected at 7th wave after 21 years (cross-sectional)

  5. LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale

    Time frame: collected at 7th wave after 21 years (cross-sectional)

  6. LASA study: 15-Words Test: Word Learning

    Time frame: 21 years: 7 waves separated by 3 year intervals

  7. LASA study: 15-Words Test: Delayed Recall

    Time frame: 21 years: 7 waves separated by 3 year intervals

  8. LASA study: Functional Independence Scale

    Time frame: 18 years: 6 waves with 3 year intervals

  9. LASA study: Chair Stands Test

    Time frame: 21 years: 7 waves separated by 3 year intervals

  10. LASA study: Walking Test

    Time frame: 21 years: 7 waves separated by 3 year intervals

  11. LASA study: Cardigan Test

    Time frame: 21 years: 7 waves separated by 3 year intervals

  12. LASA study: Balance Test

    Time frame: 21 years: 7 waves separated by 3 year intervals

Other outcomes

  1. InterRAI: Cognitive Performance Scale

    Time frame: 16 months

  2. InterRAI: ADL Hierarchy Scale

    Time frame: 16 months

  3. InterRAI: Timed 4 meter Walk Test

    Time frame: 16 months

  4. InterRAI: Distance walked in past 3 days

    Time frame: 16 months

  5. InterRAI: Hours of physical activity in past 3 days

    Time frame: 16 months

  6. InterRAI: Days of coming outside in past 3 days

    Time frame: 16 months

Sponsors and collaborators

Lead sponsor

University of Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 19, 2017
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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