|- candidate number||9243|
|- NTR Number||NTR2812|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-mrt-2011|
|- Secondary IDs||11/010 / 208020001; METC VUmc / ZonMw|
|- Public Title||Hands4U: Prevention of hand eczema among health care workers.|
|- Scientific Title||Hands4U: A multifaceted strategy to implement guideline-based recommendations to prevent hand eczema in health care workers.|
|- hypothesis||The hypothesis is: Using a multifaceted strategy, the implementation of recommandations will be more succesfull than by using a single strategy. The implemented recommandations will prevent hand eczema among health care workers. |
|- Healt Condition(s) or Problem(s) studied||Hand eczema|
|- Inclusion criteria||We include participants who:|
1. Are at risk for developing hand eczema;
2. Are able to fill out Dutch questionnaires;
3. Are employed at one of the participating hospitals;
4. Are 18 -65 years old.
|- Exclusion criteria||We exclude particpants who:|
1. Work less than 8 hours a week.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2011|
|- planned closingdate||1-jan-2014|
|- Target number of participants||3000|
|- Interventions||The randomisation to the intervention group or the control group takes place on the level of the departments of the participating hospitals to avoid contamination.
The control group will receive a leaflet of evidence based recommendations on prevention of occupational skin diseases derived from the guideline on contact dermatitis from the Dutch Board for Occupational Medicine (NVAB). If proven to be effective, the control group will also receive the implementation strategies for the prevention program at the end of this study after the last follow-up. Further, the control departments will receive questionnaires at baseline and follow up measurements.
The intervention group will receive the multifaceted implementation strategy which consist of an educational program, participatory working groups and role models. During the educational sessions workers receive information on (the prevention of) hand eczema.
The goal of the participatory working groups is to detect problems with the implementation of the recommendations. A group of 3 -5 workers will detect these problems, find solutions for it and implement these solutions at their department. These workers are also trained to become role models for their colleagues. The role models will place reminders at the department.
Further the intervention group will receive the same leaflet as the control group and the same measurements. The intervention group is also involved in the process evaluation and will receive questionnaires in a result of that.
|- Primary outcome||Hand eczema will be measured using the NOSQ-2002 questions D1, D2 and D5 (Flyvholm et al, 2002; Susitaival et al, 2003).|
|- Secondary outcome||1. Symptoms of hand eczema are measured by a questionnaire derived from the NVAB guideline which was validated by Smit et al (1992);|
2. The actual use of preventive measures is measured with a modified version of section E of the Nordic Occupational Skin Questionnaire (NOSQ-2002) (Flyvholm et al, 2002; Susitaival et al, 2003). In addition purchase data is used;
3. ASE determinants (attitude, social influence, self-efficacy and intention) will be measured by questions based on questionnaires from Driessen et al (2008) and Vyth et al (2011);
4. Disease specific quality of life is measured using the Dutch version of the DLQI (Evers et al, 2009);
5. Workers' global assesment of the health of their hands and patientsí global assessment of eczema will be assessed, using a Visual Analogue Scale (VAS) from the NOSQ-2002 (Flyvholm et al, 2002; Susitaival et al, 2003);
6. Data on sickness absence and reduced work productivity due to hand eczema will be collected in the questionnaires by using the PRODISQ (Koopmanschap et al, 2005) and the WHO-HPQ (Kessler et al, 2003; Kessler et al, 2004);
7. Psychosocial work characteristics will be measured by means of a Dutch version of Karasek's Job Content Questionnaire containing the constructs: decision authority and co-worker support (Karasek et al, 1998).
|- Timepoints||Measurements take place at baseline and after 3, 6, 9 and 12 months. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Ms. PhD. Cecile R.L. Boot|
|- CONTACT for SCIENTIFIC QUERIES||Ms. PhD. Cecile R.L. Boot|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute, Department of Public and Occupational Health|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The Hands4U study is a randomised controlled trial. The goal of the study is to implement recommendations for the prevention of hand eczema among health care workers thereby preventing hand eczema to occur. Three hospitals in the Netherlands will participate in the study. Randomisation takes place on the levels of departments. The intervention consists out of a participatory working group, educational sessions, reminders and role models. The control groups only receives a leaflet containing the recommendations. Measurements take place at baseline and after 3, 6, 9 and 12 months. Questionnaires are the method of measurement. In total 3000 health care workers are recruited. |
|- Main changes (audit trail)|
|- RECORD||16-mrt-2011 - 25-mrt-2011|