Inflammatory ArthritisRENOIRNCT04015960
Inflammatory Arthritis and Difficulty at Work
An observational study of Inflammatory Arthritis, run by University of Lorraine at 1 site in France.
Trial summary
Despite biologic drugs and improvements of inflammatory arthritis (IA) treatment, many patients with inflammatory arthritis still face increased absenteeism, reduced at-work productivity and report difficulties working and having to give up their jobs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Arthritis
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 30 Jul 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with inflammatory arthritis (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis) with difficulties at work
Who may be able to join
- Physician diagnosis of IA (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis)
- Age 18 to 65 years
- Currently employed
- Having concerns about their IA at work ("Do you have any concern about your arthritis affecting your ability to work now, or in the next five years?),
Who cannot join
- Sick leave of more than 3 years
- Health care professionals (clinicians, nurses experts in therapeutic education, occupational physicians), a vocational counsellor, and professionals of the prevention and security at work, professionals from the pension insurance fund and health at work or professionals involved in accommodation of working conditions for disabled workers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the effectiVeness of an ADaptation of the Making It-Work Intervention in a French Environment-pilot
Despite biologic drugs and improvements of inflammatory arthritis (IA) treatment, many patients with inflammatory arthritis still face increased absenteeism, reduced at-work productivity and report difficulties working and having to give up their jobs. Such professional limitation generates psychological stress and it felt generally as a premature social ageing.
"Making-it-Work" is an intervention developed in English speaking Canada, which aims at enabling both patients and employers to intervene early during the course of inflammatory arthritis to reduce possible problems at work, and to prevent sick leave and future work disability in the long term and improve well-being at work.
Read more
As part of the EVADE (Evaluation of the effectiVeness of an ADaptation of the Making it-Work intervention in a French Environment) project which aims at evaluating the effectiveness of an adaptation of the "Making-it-Work" intervention, to the French environment, the investigators propose :
- to identify the problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment.
- to develop a questionnaire to assess difficulties at work, needs for adaptations and support and motivations to work of patients with inflammatory arthritis.
Read the detailed description
The development of the patient-reported outcome (PRO) measure will comprise:
Step 1: Identifying themes and generating items by
- Conducting focus groups and/or individual semi-structured interviews with patients with IA to identify the problems faced at work due to the disease and identify strategies helpful for maintaining employment. Work characteristics, work environment, and social, economic factors and role of family members will receive specific attention.
- Conducting focus groups including patients with IA who stay at work despite the disease to identify their motivations and needs to stay at work.
- Conducting individual semi-structured interviews with health care professionals and professionals of the prevention and security at work
- Conducting the thematic analysis, following a general inductive approach
Step 2: Selecting items using a Delphi method using a panel of patients and health care professionals
Step 3: Items reconciliation and selection by an expert panel
Step 4: Cognitive debriefing of selected items (pre-test).
Step 5: Evaluate psychometric properties will follow the standards for assessing validity of a complex measurement scale, checking for truth, discrimination and feasibility ((Outcome Measures in Rheumatology (OMERACT) filter 2.0) according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) check-list. Scale measurement properties will be assessed using Rasch measurement methods.
- Conditions
- Inflammatory Arthritis
- Being tested
- no intervention
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
qualitative research and patient reported outcome measure (PROm) development
What is being measured
The primary outcome is the main question the study is designed to answer.
Problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment.
focus groups and/or individual semi-structured interviews
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Why it stopped: lack of ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Christine Rat, University of Lorraine
- Investigators
- Anne-Christine Rat, MD, PhD, Principal investigator, University of LorraineIsabelle Thaon, MD, PhD, Principal investigator, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015960
- Sponsor's protocol ID
- EVADE-pilot
- Acronym
- RENOIR
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2019
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the effectiVeness of an ADaptation of the Making It-Work Intervention in a French Environment-pilot
- ClinicalTrials.gov ID
- NCT04015960
- Acronym / sponsor ID
- RENOIR / EVADE-pilot
- Conditions
- Inflammatory Arthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 11 Jul 2019 (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.
Despite biologic drugs and improvements of inflammatory arthritis (IA) treatment, many patients with inflammatory arthritis still face increased absenteeism, reduced at-work productivity and report difficulties working and having to give up their jobs. Such professional limitation generates psychological stress and it felt generally as a premature social ageing.
"Making-it-Work" is an intervention developed in English speaking Canada, which aims at enabling both patients and employers to intervene early during the course of inflammatory arthritis to reduce possible problems at work, and to prevent sick leave and future work disability in the long term and improve well-being at work.
As part of the EVADE (Evaluation of the effectiVeness of an ADaptation of the Making it-Work intervention in a French Environment) project which aims at evaluating the effectiveness of an adaptation of the "Making-it-Work" intervention, to the French environment, the investigators propose :
- to identify the problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment.
- to develop a questionnaire to assess difficulties at work, needs for adaptations and support and motivations to work of patients with inflammatory arthritis.
Detailed description
The development of the patient-reported outcome (PRO) measure will comprise:
Step 1: Identifying themes and generating items by
- Conducting focus groups and/or individual semi-structured interviews with patients with IA to identify the problems faced at work due to the disease and identify strategies helpful for maintaining employment. Work characteristics, work environment, and social, economic factors and role of family members will receive specific attention.
- Conducting focus groups including patients with IA who stay at work despite the disease to identify their motivations and needs to stay at work.
- Conducting individual semi-structured interviews with health care professionals and professionals of the prevention and security at work
- Conducting the thematic analysis, following a general inductive approach
Step 2: Selecting items using a Delphi method using a panel of patients and health care professionals
Step 3: Items reconciliation and selection by an expert panel
Step 4: Cognitive debriefing of selected items (pre-test).
Step 5: Evaluate psychometric properties will follow the standards for assessing validity of a complex measurement scale, checking for truth, discrimination and feasibility ((Outcome Measures in Rheumatology (OMERACT) filter 2.0) according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) check-list. Scale measurement properties will be assessed using Rasch measurement methods.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory arthritis (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis) with difficulties at work
Key inclusion criteria (4 listed)
Key exclusion criteria (2 listed)
- Health care professionals (clinicians, nurses experts in therapeutic education, occupational physicians), a vocational counsellor, and professionals of the prevention and security at work, professionals from the pension insurance fund and health at work or professionals involved in accommodation of working conditions for disabled workers
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 |
|---|---|---|
| no interventionqualitative research and patient reported outcome measure (PROm) development | Other | – |
Primary outcome
Problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment.
Time frame: baseline
focus groups and/or individual semi-structured interviews
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Anne-Christine Rat, MD, PhD principal investigator
University of Lorraine
Isabelle Thaon, MD, PhD principal investigator
University of Lorraine
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 Inflammatory Arthritis, run by University of Lorraine 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 25 Jun 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment. (time frame: baseline). 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 25 Jun 2024.