Viewing Study NCT06543732



Ignite Creation Date: 2024-10-26 @ 3:37 PM
Last Modification Date: 2024-10-26 @ 3:37 PM
Study NCT ID: NCT06543732
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-08-05

Brief Title: VitalWork Reintegration Program for Employees With Stress-related Complaints
Sponsor: None
Organization: None

Study Overview

Official Title: VitalWork a Personalized Reintegration Program for Employees With Stress-related Complaints
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VitalWork
Brief Summary: The objective of this study VitalWork reintegration program is to support sick-listed workers with stress-related complaints in their return to work based on a personalized program Therefore the aim of this study is test whether participants supported by a tailored eHealth program and if needed additionally supported by a structured and stepwise Participatory Approach PA involving the sick-listed worker their direct supervisor and a neutral party show a faster and sustainable return to work as compared to participants in the control condition This program is investigated in four different organizations which differ in sector size small and large organizations type of organization private or public and type of work
Detailed Description: This study evaluates the effectiveness of a program incorporating diverse components to improve sustainable return to work stress-related outcomes and cost effectiveness among sick-listed workers with stress-related complaints compared to usual care The study design is a randomized controlled trial including an intervention and control group Sick-listed workers between 2 - 12 weeks sick in the intervention group receive a tailored eHealth program based on their questions on a distress screener if needed followed by the Participatory Approach PA Sick-listed workers in the control group receive standard practice and general information about return to work If sick-listed workers did not return to work after 6 weeks in the eHealth program the PA starts The PA is a structured and stepwise procedure that involves the sick-listed worker their direct supervisor and a neutral party either physically present or working in the background to guide the conversation This collaborative process aims to identify workplace-related bottlenecks and subsequently develop a consensus-based return to work plan based on a strong commitment of both the sick listed worker and employer This study offers two different forms of PA individual work modifications guided by a neutral process facilitator and job coaching guided by the employer with the process facilitator providing support in the background If sick-listed workers are experiencing stress-related complaints originating from work they will be offered individual work modifications Conversely if the issues are unrelated to work the worker will receive job coaching As information on this tailored PA approach is lacking the effectiveness of this approach is investigated By combining these different intervention components the investigators strive to fill the research gap concerning the identification of an effective re-integration program for sick-listed workers suffering from stress-related complaints Participants will be followed for 1 year

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None