Inflammatory Arthritis and Difficulty at Work

Inflammatory Arthritis Clinical Trial

— RENOIR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04015960
• Other study ID #: EVADE-pilot
• Status: Not yet recruiting
• Start date: July 15, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2019
• Source: University of Lorraine
• Contact: Déborah Loyal, PhD
• Phone: +33 3 72 74 61 96
• Email: loyald[@]hotmail.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis

Intervention

Other:
• no intervention
qualitative research and patient reported outcome measure (PROm) development

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Lorraine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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