<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03024541</url>
  </required_header>
  <id_info>
    <org_study_id>DBI InterRAI LASA</org_study_id>
    <nct_id>NCT03024541</nct_id>
  </id_info>
  <brief_title>Longitudinal Analysis of Drug Burden Index</brief_title>
  <official_title>Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anticholinergic and sedative drugs are frequently prescribed to older people, despite their&#xD;
      negative impact on older people's physical and cognitive function. To estimate the cumulative&#xD;
      exposure to anticholinergic and sedative drugs, Hilmer et al. published the Drug Burden Index&#xD;
      (DBI) in 2007. The present study aims to complement previous study findings showing higher&#xD;
      DBI values to be associated with physical and cognitive impairment. Most previously conducted&#xD;
      studies of the DBI were either cross-sectional or were longitudinal but with short&#xD;
      follow-ups. Furthermore, it remains unknown whether higher DBI values carry extra risks for&#xD;
      patients with dementia. Finally, relatively little is known about the stability of DBI values&#xD;
      over time. The current project therefore aims to examine (1) longitudinal relationships&#xD;
      between long-term cumulative exposure to anticholinergic and sedative drugs as measured with&#xD;
      the DBI and cognitive and physical function, (2) to examine interaction effects between DBI&#xD;
      exposure and dementia, and (3) to examine trajectories of DBI exposure, i.e. DBI exposure&#xD;
      remaining stable, declining, increasing or fluctuating over time. These project aims will be&#xD;
      studied with longitudinal data from eligible participants &gt; 60 years from the LASA study with&#xD;
      participants being followed-up during two decades, and the longitudinal data from the&#xD;
      InterRAI consortium. Various clinical outcomes regarding cognitive and physical function will&#xD;
      be studied. Data will be analysed with generalised linear mixed models and Latent Class&#xD;
      Growth Analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>LASA study: Alphabet Coding Task</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>LASA study: Mini Mental Status Examination</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Verbal Fluency Test: Phonemic fluency</measure>
    <time_frame>collected at 7th wave after 21 years (cross-sectional)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Verbal Fluency Test: Semantic fluency</measure>
    <time_frame>collected at 7th wave after 21 years (cross-sectional)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale</measure>
    <time_frame>collected at 7th wave after 21 years (cross-sectional)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale</measure>
    <time_frame>collected at 7th wave after 21 years (cross-sectional)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: 15-Words Test: Word Learning</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: 15-Words Test: Delayed Recall</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Functional Independence Scale</measure>
    <time_frame>18 years: 6 waves with 3 year intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Chair Stands Test</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Walking Test</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Cardigan Test</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LASA study: Balance Test</measure>
    <time_frame>21 years: 7 waves separated by 3 year intervals</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>InterRAI: Cognitive Performance Scale</measure>
    <time_frame>16 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>InterRAI: ADL Hierarchy Scale</measure>
    <time_frame>16 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>InterRAI: Timed 4 meter Walk Test</measure>
    <time_frame>16 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>InterRAI: Distance walked in past 3 days</measure>
    <time_frame>16 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>InterRAI: Hours of physical activity in past 3 days</measure>
    <time_frame>16 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>InterRAI: Days of coming outside in past 3 days</measure>
    <time_frame>16 months</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9985</enrollment>
  <condition>Polypharmacy</condition>
  <condition>Anticholinergics</condition>
  <condition>Hypnotics and Sedatives</condition>
  <condition>Cognitive Function</condition>
  <condition>Physical Function</condition>
  <arm_group>
    <arm_group_label>LASA study</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>InterRAI consortium</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        People aged 55 years and older, both community-dwelling individuals and individuals living&#xD;
        in residential aged care facilities&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        LASA:&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  55 years and older&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  problem drinkers in the past and the present&#xD;
&#xD;
          -  very severe vision and hearing problems&#xD;
&#xD;
        InterRAI:&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  55 years or older&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  consumption of 5 or more units of alcohol on one occasion&#xD;
&#xD;
          -  unknown sex or age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 18, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Groningen</investigator_affiliation>
    <investigator_full_name>Katja Taxis</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not Applicable: Permission to use the data should be obtained from the LASA and/or InterRAI researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024541
org study id: DBI InterRAI LASA
nct id: NCT03024541
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: LASA study: Alphabet Coding Task
time frame: 21 years: 7 waves separated by 3 year intervals
measure: LASA study: Mini Mental Status Examination
time frame: 21 years: 7 waves separated by 3 year intervals
measure: LASA study: Verbal Fluency Test: Phonemic fluency
time frame: collected at 7th wave after 21 years (cross-sectional)
measure: LASA study: Verbal Fluency Test: Semantic fluency
time frame: collected at 7th wave after 21 years (cross-sectional)
measure: LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale
time frame: collected at 7th wave after 21 years (cross-sectional)
measure: LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale
time frame: collected at 7th wave after 21 years (cross-sectional)
measure: LASA study: 15-Words Test: Word Learning
time frame: 21 years: 7 waves separated by 3 year intervals
measure: LASA study: 15-Words Test: Delayed Recall
time frame: 21 years: 7 waves separated by 3 year intervals
measure: LASA study: Functional Independence Scale
time frame: 18 years: 6 waves with 3 year intervals
measure: LASA study: Chair Stands Test
time frame: 21 years: 7 waves separated by 3 year intervals
measure: LASA study: Walking Test
time frame: 21 years: 7 waves separated by 3 year intervals
measure: LASA study: Cardigan Test
time frame: 21 years: 7 waves separated by 3 year intervals
measure: LASA study: Balance Test
time frame: 21 years: 7 waves separated by 3 year intervals
measure: InterRAI: Cognitive Performance Scale
time frame: 16 months
measure: InterRAI: ADL Hierarchy Scale
time frame: 16 months
measure: InterRAI: Timed 4 meter Walk Test
time frame: 16 months
measure: InterRAI: Distance walked in past 3 days
time frame: 16 months
measure: InterRAI: Hours of physical activity in past 3 days
time frame: 16 months
measure: InterRAI: Days of coming outside in past 3 days
time frame: 16 months
arm group label: LASA study
arm group label: InterRAI consortium
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Groningen
investigator full name: Katja Taxis
investigator title: Professor
sharing ipd: Undecided
ipd description: Not Applicable: Permission to use the data should be obtained from the LASA and/or InterRAI researchers