Inflammatory Arthritis and Difficulty at Work — RENOIR  

Inflammatory Arthritis Clinical Trial

Official title: Evaluation of the effectiVeness of an ADaptation of the Making It-Work Intervention in a French Environment-pilot

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis

• NCT number: NCT04015960
• Study type: Observational
• Source: University of Lorraine
• Contact: Déborah Loyal, PhD
• Phone: +33 3 72 74 61 96
• Email: loyald@hotmail.fr
• Status: Not yet recruiting
• Start date: July 15, 2019
• Completion date: July 30, 2021