Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital (ALGOGER)

September 7, 2023 updated by: Centre Hospitalier Universitaire de Nīmes

Chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population.

it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. This study would make it possible to characterize elderly patients with chronic pain, in order to consider, in a future study, setting up a pharmaceutical consultation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU Nimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients aged at least 65 years consulting at the pain centre of the Nîmes University Hospital for chronic pain

Description

Inclusion Criteria:

  • The patient must be affiliated or beneficiary of a health insurance
  • Patient ≥ 65 years old
  • Having an outpatient consultation at the pain centre of the Nîmes University hospital of for chronic pain
  • Available for pharmaceutical consultation about 30 minutes

Exclusion Criteria:

  • It is impossible to give information
  • The patient objects to participating in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the ADE Geriatric risk score
Time Frame: 2018
The score is calculated on 10 points based on 3 criteria : number of drugs prescribed, prescription of neuroleptics and the initiation of an anticoagulant prescription less than 3 months old. It classifies patients into 3 risk categories: a low risk level for a score of 0 to 1 point, a medium risk level for a score of 2 to 5 points and a high risk level for a score of 6 to 10 points.
2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of patients with a low, medium or high risk level calculated by ADE Geriatric risk score according to the type of pain
Time Frame: 2018
The score is calculated on 10 points based on 3 criteria : number of drugs prescribed, prescription of neuroleptics and the initiation of an anticoagulant prescription less than 3 months old. It classifies patients into 3 risk categories: a low risk level for a score of 0 to 1 point, a medium risk level for a score of 2 to 5 points and a high risk level for a score of 6 to 10 points.
2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: geraldine leguelinel, Dr, CHU Nimes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

June 16, 2018

Study Completion (Actual)

June 16, 2018

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Local/2017/GL-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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