NCT03623542

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
Last Updated

August 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

July 19, 2018

Last Update Submit

August 8, 2018

Conditions

Keywords

Dementiaalzheimer dementia

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Damien JOLLY

Reims, France

Location

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

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

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

Locations