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Longitudinal Analysis of Drug Burden Index

Sponsor
University of Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT03024541
Collaborator
(none)
9,985
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9985 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index
    Study Start Date :
    Jun 1, 2016
    Actual Primary Completion Date :
    Jun 1, 2016
    Actual Study Completion Date :
    Jun 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    LASA study
    InterRAI consortium

    Outcome Measures

    Primary Outcome Measures

    1. LASA study: Alphabet Coding Task [21 years: 7 waves separated by 3 year intervals]

    Secondary Outcome Measures

    1. LASA study: Mini Mental Status Examination [21 years: 7 waves separated by 3 year intervals]

    2. LASA study: Verbal Fluency Test: Phonemic fluency [collected at 7th wave after 21 years (cross-sectional)]

    3. LASA study: Verbal Fluency Test: Semantic fluency [collected at 7th wave after 21 years (cross-sectional)]

    4. LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale [collected at 7th wave after 21 years (cross-sectional)]

    5. LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale [collected at 7th wave after 21 years (cross-sectional)]

    6. LASA study: 15-Words Test: Word Learning [21 years: 7 waves separated by 3 year intervals]

    7. LASA study: 15-Words Test: Delayed Recall [21 years: 7 waves separated by 3 year intervals]

    8. LASA study: Functional Independence Scale [18 years: 6 waves with 3 year intervals]

    9. LASA study: Chair Stands Test [21 years: 7 waves separated by 3 year intervals]

    10. LASA study: Walking Test [21 years: 7 waves separated by 3 year intervals]

    11. LASA study: Cardigan Test [21 years: 7 waves separated by 3 year intervals]

    12. LASA study: Balance Test [21 years: 7 waves separated by 3 year intervals]

    Other Outcome Measures

    1. InterRAI: Cognitive Performance Scale [16 months]

    2. InterRAI: ADL Hierarchy Scale [16 months]

    3. InterRAI: Timed 4 meter Walk Test [16 months]

    4. InterRAI: Distance walked in past 3 days [16 months]

    5. InterRAI: Hours of physical activity in past 3 days [16 months]

    6. InterRAI: Days of coming outside in past 3 days [16 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Groningen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katja Taxis, Professor, University of Groningen
    ClinicalTrials.gov Identifier:
    NCT03024541
    Other Study ID Numbers:
    • DBI InterRAI LASA
    First Posted:
    Jan 19, 2017
    Last Update Posted:
    Jan 19, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    No Results Posted as of Jan 19, 2017