Longitudinal Analysis of Drug Burden Index

NCT ID: NCT03024541

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9985 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Polypharmacy Anticholinergics Hypnotics and Sedatives Cognitive Function Physical Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LASA study

No interventions assigned to this group

InterRAI consortium

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 55 years and older


* 55 years or older

Exclusion Criteria

* problem drinkers in the past and the present
* very severe vision and hearing problems

InterRAI:


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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Groningen

OTHER

Sponsor Role lead

Responsible Party

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Katja Taxis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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DBI InterRAI LASA

Identifier Type: -

Identifier Source: org_study_id

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