Adverse Drug Reactions in Older Subjects
RiskofADR
Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit
1 other identifier
observational
293
1 country
1
Brief Summary
Objective: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation. Design: Longitudinal prospective study from May 2010 to November 2011. Setting: Dedicated acute geriatric care unit specializing in the management of patients with dementia at the University Hospital of Reims, France. Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedAugust 9, 2018
July 1, 2018
1.5 years
July 19, 2018
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Risk factors for the occurrence of adverse drug reactions
Factors (as comprehensive geriatric assessment : instrumental activities of daily living scale, Katz's activities of daily living scale, mini nutritional assessment short-form, mini mental state examination) associated with adverse drug reaction
Month 18
Study Arms (1)
Dementia or alzheimer dementia
All patients presenting with dementia syndrome and whose admission was unplanned between May 2010 and November 2011 were consecutively included in the study.
Eligibility Criteria
All patients presenting with dementia syndrome and whose admission was unplanned between May 2010 and November 2011 were consecutively included in the study.
You may qualify if:
- diagnosis of dementia syndrome
- unplanned hospitalisation between may 2010 and november 2011
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Damien JOLLY
Reims, France
Related Publications (1)
Kanagaratnam L, Drame M, Novella JL, Trenque T, Joachim C, Nazeyrollas P, Jolly D, Mahmoudi R. Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit. Am J Geriatr Psychiatry. 2017 Mar;25(3):290-296. doi: 10.1016/j.jagp.2016.07.002. Epub 2016 Sep 1.
PMID: 27742527BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2018
First Posted
August 9, 2018
Study Start
May 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
August 9, 2018
Record last verified: 2018-07