Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-28 @ 8:53 PM
Study NCT ID:
NCT04015960
Status:
WITHDRAWN
Last Update Posted:
2024-06-25
First Post:
2019-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Arthritis and Difficulty at Work
Sponsor:
University of Lorraine
Organization:
Study Overview
Official Title:
Evaluation of the effectiVeness of an ADaptation of the Making It-Work Intervention in a French Environment-pilot
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of ressources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RENOIR
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 :
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.
"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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: