Longitudinal Analysis of Drug Burden Index

January 13, 2017 updated by: Katja Taxis, University of Groningen

Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9985

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People aged 55 years and older, both community-dwelling individuals and individuals living in residential aged care facilities

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
LASA study
InterRAI consortium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
LASA study: Alphabet Coding Task
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
LASA study: Mini Mental Status Examination
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals
LASA study: Verbal Fluency Test: Phonemic fluency
Time Frame: collected at 7th wave after 21 years (cross-sectional)
collected at 7th wave after 21 years (cross-sectional)
LASA study: Verbal Fluency Test: Semantic fluency
Time Frame: collected at 7th wave after 21 years (cross-sectional)
collected at 7th wave after 21 years (cross-sectional)
LASA study: Digit Span Forward from Wechsler Adult Intelligence Scale
Time Frame: collected at 7th wave after 21 years (cross-sectional)
collected at 7th wave after 21 years (cross-sectional)
LASA study: Digit Span Backward from Wechsler Adult Intelligence Scale
Time Frame: collected at 7th wave after 21 years (cross-sectional)
collected at 7th wave after 21 years (cross-sectional)
LASA study: 15-Words Test: Word Learning
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals
LASA study: 15-Words Test: Delayed Recall
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals
LASA study: Functional Independence Scale
Time Frame: 18 years: 6 waves with 3 year intervals
18 years: 6 waves with 3 year intervals
LASA study: Chair Stands Test
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals
LASA study: Walking Test
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals
LASA study: Cardigan Test
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals
LASA study: Balance Test
Time Frame: 21 years: 7 waves separated by 3 year intervals
21 years: 7 waves separated by 3 year intervals

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
InterRAI: Cognitive Performance Scale
Time Frame: 16 months
16 months
InterRAI: ADL Hierarchy Scale
Time Frame: 16 months
16 months
InterRAI: Timed 4 meter Walk Test
Time Frame: 16 months
16 months
InterRAI: Distance walked in past 3 days
Time Frame: 16 months
16 months
InterRAI: Hours of physical activity in past 3 days
Time Frame: 16 months
16 months
InterRAI: Days of coming outside in past 3 days
Time Frame: 16 months
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DBI InterRAI LASA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not Applicable: Permission to use the data should be obtained from the LASA and/or InterRAI researchers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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