Inflammatory Arthritis and Difficulty at Work (RENOIR)

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.

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 :

1. to identify the problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment.
2. to develop a questionnaire to assess difficulties at work, needs for adaptations and support and motivations to work of patients with inflammatory arthritis.

Study Overview

• Status: Withdrawn
• Conditions: Inflammatory Arthritis
• Intervention / Treatment: Other: no intervention

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • Université Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory arthritis (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis) with difficulties at work

Description

1. Patients

   Inclusion Criteria:

   • 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?),

   Exclusion Criteria:

   • Sick leave of more than 3 years

2. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline

Collaborators and Investigators

• Sponsor: University of Lorraine
• Investigators: Principal Investigator: Anne-Christine Rat, MD, PhD, University of Lorraine; Principal Investigator: Isabelle Thaon, MD, PhD, University of Lorraine

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2019
• Primary Completion (Estimated): July 30, 2020
• Study Completion (Estimated): July 30, 2021

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: EVADE-pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No