|- candidate number||12393|
|- NTR Number||NTR3445|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-mei-2012|
|- Secondary IDs||50-51400-98-020 ZonMw|
|- Public Title||Sustained employment in the meat processing industry: The FLESH study.|
|- Scientific Title||The assesment of sustained employability of workers in a production environment: A cluster randomized stepped wedge trial.|
|- ACRONYM||FLESH (Functional Labour Evaluation for Sustained Health and employment)|
|- hypothesis||We hypothesize that implementation of a workers's health surveillance and consecutive interventions will lead to prevention of injury and disability, health improvement, and eventually sustained employment.|
|- Healt Condition(s) or Problem(s) studied||Occupational health, Meat-packing industry, Work capacity evaluation, Work load, Job satisfaction|
|- Inclusion criteria||Five representative locations of a large meat processing company are included in this study. The intention is to include all contracted employees at these locations (staff and production personnel).|
|- Exclusion criteria||Employees installed by job agencies, not contracted by the meat processing company.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2011|
|- planned closingdate||30-nov-2015|
|- Target number of participants||230|
|- Interventions||At each location of the meat processing company a workers' health surveillance (WHS) and consecutive interventions will be implemented.
The WHS consists of a questionnaire on physical and psychological aspects related to work and daily life, several biometric assessments, a functional capacity evaluation (FCE), and a counselling session on the results of the beforementioned assessments. If results indicate that measures must be taken, employees are directed to e.g. a physiotherapist, an occupational therapist, or a physician.|
This is considered care as usual (CAU). To evaluate CAU, a questionnaire study will be conducted by the research team. The questionnaire is administered at each timepoint described below. This questionnaire contains all primary and secondary outcomes.
In addition to evaluating the effectiveness of the WHS, a cost effectiveness study will be conducted from the employer's perspective.
This study is set-up with a stepped wedge design. The WHS will be implemented one location at a time (in total five locations are included in this study). In this design locations serve as their own control, but they also serve as control for the other locations.
|- Primary outcome||1. Work ability (WAI);|
2. Productivity (QQ questionnaire, company data);
3. Absenteeism (data from Occupational Health Service).
|- Secondary outcome||1. Psychosocial workload (COPSOQ);|
2. Health status (EQ-5D);
3. Vitality (RAND-36);
4. Movement (VBA1a);
5. Work reintegration (VAR);
6. Personal and work characteristics.
|- Timepoints||Feb/mar 2012: WHS location 1, locations 2-5 serve as control.|
Jun 2012: WHS location 2, locations 1, 3-5 serve as control.
Nov 2012: WHS location 3, locations 1, 2, 4, 5 serve as control.
Apr 2013: WHS location 4, locations 1-3, 5 serve as control.
Aug/sept 2013: WHS location 5, locations 1-4 serve as control.
Jan 2014: Control at all locations.
Jul 2014: Control at all locations.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.F. Reneman|
|- CONTACT for SCIENTIFIC QUERIES|| M.F. Reneman|
|- Sponsor/Initiator ||VION Food Group B.V.|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||A large meat processing company has the ambition to improve their employees' sustained employability. They want to achieve this goal by implementing a job-specific workers' health surveillance (WHS) companywide. A pilot implementation has started in 2011. Starting in 2012 this surveillance will be implemented at all company locations in The Netherlands (± 2300 employees). Based on the WHS and a risk inventory, plans will be made by employee, employer and occupational physician for interventions, aimed at preservation or recovery of sustained employment. The WHS and interventions together are called WHS-SE (Workers'Health Surveillance - Sustained Employment). This study is designed to assess the effectiveness of WHS-SE. The study uses a cluster randomized stepped wedge trial design. The study incorporates a phased intervention period of 2 years, where locations where WHS-SE has not been implemented yet, will serve as control. The WHS-SE will be evaluated with 1 year follow-up.|
|- Main changes (audit trail)|
|- RECORD||21-mei-2012 - 3-jun-2012|