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Completed

NCT Number: NCT03623542

Adverse Drug Reactions in Older Subjects

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.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Damien JOLLY

Reims, France

About this study

Introduction: Adverse drug reactions (ADRs) are frequent among older subjects, and are actually avoidable in up to 60% of cases. There are few studies identifying the risk factors for ADRs based on comprehensive geriatric assessment in older subjects with dementia, although better identification of patients at risk could help to target patients at risk for increased morbidity and mortality due to ADRs with a view to taking appropriate preventive measures.

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 syndrome (Alzheimer disease or related syndromes) at the University Hospital of Reims, France.

Participants: Older patients with dementia syndrome (Alzheimer disease or related syndromes).

Measurements: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of dementia syndrome
  • unplanned hospitalisation between may 2010 and november 2011

Exclusion criteria

  • no exclusion criteria

Treatment and study plan

Primary outcomes

  1. Risk factors for the occurrence of adverse drug reactions

    Time frame: Month 18

    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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit

Acronym: RiskofADR

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 9, 2018
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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