NCT04006444

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

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

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

September 8, 2023

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

July 1, 2019

Last Update Submit

September 7, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evolution of the ADE Geriatric risk score

    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 Outcomes (1)

  • rate of patients with a low, medium or high risk level calculated by ADE Geriatric risk score according to the type of pain

    2018

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • Jambon J, Choukroun C, Roux-Marson C, Viel E, Leguelinel-Blache G. What Is the Medication Iatrogenic Risk in Elderly Outpatients for Chronic Pain? Clin Neuropharmacol. 2022 May-Jun 01;45(3):65-71. doi: 10.1097/WNF.0000000000000505.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • geraldine leguelinel, Dr

    CHU NIMES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

March 1, 2018

Primary Completion

June 16, 2018

Study Completion

June 16, 2018

Last Updated

September 8, 2023

Record last verified: 2019-06

Locations