Arthritis, RheumatoidNCT03306784
Pain Catastrophizing and Routine Assessment of Patient Index Data 3(RAPID3) in Ten Categories of Rheumatology Outpatients
An observational study of Arthritis, Rheumatoid and Spondyloarthritis, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Spondyloarthritis, Inflammatory Rheumatisms
- What is being tested?
- questionnaires
- How many people
- 572 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2017to 31 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients not fluent enough in French or suffering from neurological or psychological disorders making their responses unreliable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversal Study of Correlations Between Pain Catastrophizing Scale (PCS) and RAPID3 Score According to Ten Categories of Conditions Seen in an Outpatient Rheumatology Clinic
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.
Read the detailed description
Fulfilling by all patients (seen by 6 rheumatologists in a same outpatient rheumatology clinic from a university French hospital in at least one month period) of a set of 6 questionnaires including a RAPID3 score (Routine Assessment of Patient Index Data 3) and pain catastrophizing scale, as well as Pain detect and Hospital Anxiety and Depression scale questionnaires (HAD) , in ten predefined categories of disorders: rheumatoid arthritis; any spondyloarthritis; other inflammatory rheumatisms or systemic disorders; osteoarthritis of the upper part of the body; osteoarthritis of the lower part of the body; back pain and/or radiculalgia; bone disorders, including osteoporosis; tendinosis and other soft tissue conditions; peripheral neuropathy, including entrapment neuropathies; fibromyalgia and related conditions.
- Being tested
- questionnaires
- Keywords
- RAPID3, pain catastrophizing
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
questionnaires, including RAPID3 and pain catastrophizing scales
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients
Measured: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start3 Jul 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marie Berthelot, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306784
- Sponsor's protocol ID
- RC17_0182
- Status last verified
- Sep 2021
- First submitted
- 5 Jul 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversal Study of Correlations Between Pain Catastrophizing Scale (PCS) and RAPID3 Score According to Ten Categories of Conditions Seen in an Outpatient Rheumatology Clinic
- ClinicalTrials.gov ID
- NCT03306784
- Acronym / sponsor ID
- RC17_0182
- Keywords
- RAPID3, pain catastrophizing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fulfilling by all patients (seen by 6 rheumatologists in a same outpatient rheumatology clinic from a university French hospital in at least one month period) of a set of 6 questionnaires including a RAPID3 score (Routine Assessment of Patient Index Data 3) and pain catastrophizing scale, as well as Pain detect and Hospital Anxiety and Depression scale questionnaires (HAD) , in ten predefined categories of disorders: rheumatoid arthritis; any spondyloarthritis; other inflammatory rheumatisms or systemic disorders; osteoarthritis of the upper part of the body; osteoarthritis of the lower part of the body; back pain and/or radiculalgia; bone disorders, including osteoporosis; tendinosis and other soft tissue conditions; peripheral neuropathy, including entrapment neuropathies; fibromyalgia and related conditions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not fluent enough in French or suffering from neurological or psychological disorders making their responses unreliable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesquestionnaires, including RAPID3 and pain catastrophizing scales | Other | – |
Primary outcome
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).
Time frame: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
Composite score: RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients.
1 secondary outcome
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)
Time frame: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Berthelot, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Spondyloarthritis, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.