RENOIR: Inflammatory Arthritis and Difficulty at Work

Sponsor

University of Lorraine (Other)

Overall Status

Unknown status

CT.gov ID

NCT04015960

Collaborator

(none)

450

Enrollment

24.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 :

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Arthritis	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 Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

Jul 30, 2020

Anticipated Study Completion Date :

Jul 30, 2021

Outcome Measures

Primary Outcome Measures

Problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment. [baseline]
focus groups and/or individual semi-structured interviews

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Lorraine

Investigators

Principal Investigator: Anne-Christine Rat, MD, PhD, University of Lorraine
Principal Investigator: Isabelle Thaon, MD, PhD, University of Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anne-Christine Rat, Principal investigator, University of Lorraine

ClinicalTrials.gov Identifier:

NCT04015960

Other Study ID Numbers:

EVADE-pilot

First Posted:

Jul 11, 2019

Last Update Posted:

Jul 12, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Study Results

No Results Posted as of Jul 12, 2019