NCT04979364

Brief Summary

French translation and validation of the Prescription Opioid Misuse Index scale (POMI), a brief questionnaire to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic non-cancer pain (CNCP), this tool is particularly interesting to use during medical consultations to screen misuse in opioids user patients. We conducted an observational, prospective and multicenter psychometric study with a cross-cultural validation in 154 CNCP patients treated by opioid at least from 3 months, in two pain clinics.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

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

September 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
Last Updated

March 15, 2022

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

July 15, 2021

Last Update Submit

February 28, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • psychometric properties of POMI scale

    Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F). POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.

    Once. Day 1

  • psychometric properties of POMI scale

    Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F). POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.

    Once. At 2 to 4 weeks (Re-TEST phase)

Eligibility Criteria

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

Patients with chonic non-cancer pain.

You may qualify if:

  • patients aged 18 or more, suffered from chronic non-cancer pain for at least 6 months, with at least one analgesic opioid daily for 3 months, and follow in pain clinic.

You may not qualify if:

  • inability to read or understand questionnaires alone, cancer, and impossibility to do test and retest questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainOpioid-Related Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

July 15, 2021

First Posted

July 28, 2021

Study Start

September 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

March 15, 2022

Record last verified: 2021-07