Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03024541
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2016-10-18
Brief Title:
Longitudinal Analysis of Drug Burden Index
Sponsor:
University of Groningen
Organization:
University of Groningen
Study Overview
Official Title:
Longitudinal Analysis of Cumulative Exposure to Anticholinergic and Sedative Drugs Measured With the Drug Burden Index
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anticholinergic and sedative drugs are frequently prescribed to older people despite their negative impact on older peoples 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 ie 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None