Adverse Drug Reactions in Older Subjects

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03623542

Acronym

RiskofADR

Enrollment

293

Registered

2018-08-09

Start date

2010-05-01

Completion date

2011-11-01

Last updated

2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Dementia, alzheimer dementia

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- no

Design outcomes

Primary

Measure	Time frame	Description
Risk factors for the occurrence of adverse drug reactions	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

Countries

France

Outcome results