NCT03306784

Brief Summary

Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including RAPID3 and pain catastrophizing scales.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
572

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

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

July 3, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

July 5, 2017

Last Update Submit

September 20, 2021

Conditions

Keywords

RAPID3pain catastrophizing

Outcome Measures

Primary Outcomes (1)

  • Ranking of PCS scores according to the underlying disorders (10 predefined categories), and also ranking of RAPID-3 scores according to the underlying disorders (10 predefined categories).

    Composite score: RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients.

    At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).

Secondary Outcomes (1)

  • Ranking of correlations between RAPID3 and Pain catastrophizing scale (PCS) (13 items) scores in the 10 subsets of categories listed above (from the strongest correlation to the lowest correlation)

    At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).

Interventions

questionnaires, including RAPID3 and pain catastrophizing scales

Eligibility Criteria

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

300 Men or women coming to the Rheumatology Department of the Nantes University Hospital with a senior rheumatologist agreeing to fulfil the set of 6 questionnaires

You may qualify if:

  • any outpatient aged 18 or more, agreeing to fulfil the set of 6 questionnaires
  • Man or woman coming to the Rheumatology Department of the Nantes University Hospital with a senior rheumatologist

You may not qualify if:

  • Patients not fluent enough in French or suffering from neurological or psychological disorders making their responses unreliable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritisRheumatic Fever

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Marie Berthelot, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 5, 2017

First Posted

October 11, 2017

Study Start

July 3, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations