Adverse Drug Reactions in Older Subjects

Dementia Clinical Trial

— RiskofADR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03623542
• Other study ID #: 2017Ao002
• Status: Completed
• Start date: May 1, 2010
• Est. completion date: November 1, 2011

Study information

• Verified date: July 2018
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: November 1, 2011
• Est. primary completion date: November 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of dementia syndrome

• unplanned hospitalisation between may 2010 and november 2011

Exclusion Criteria:

• no exclusion criteria

Related Conditions & MeSH terms

• Dementia
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Kanagaratnam L, Dramé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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