Background: The incidence of occupational hand eczema is approximately 0.32 per 1,000 person years. The\r\nburden of the disease is high, as almost 60% has eczema-related sick leave during the first year after notification,\r\nand 15% are excluded from the workforce 12 years after disease onset. New treatments and prevention strategies\r\nare needed.\r\nMethods/Design: Trial design: The PREVEX trial is a randomised, parallel-group, superiority trial.\r\nParticipants: All individuals from the Capital Region of Denmark and Region Zealand with a suspected occupational skin\r\ndisorder notified to the National Board of Industrial Injuries between June 2012 and December 2013 are invited to\r\nparticipate in the trial. Inclusion criteria are: self-reported hand eczema and informed consent. Exclusion criteria are: age\r\n<18 years or >65 years; permanent exclusion from the workforce; inability to understand the Danish language; any\r\nserious medical condition; and lack of written informed consent. We plan to randomise 742 participants. Interventions:\r\nThe experimental intervention is an educational course in skin-protective behaviour and written information about skin\r\ncare related to the participants'' specific occupation. Also, a telephone hotline is available and a subgroup will be offered\r\na work-place visit. The experimental and the control group have access to usual care and treatment. All participants\r\nare contacted every eighth week with questions regarding number of days with sick leave or other absence\r\nfrom work. 12 months after randomisation follow-up is completed. Objective: To assesses the effect of an educational\r\ncourse versus treatment as usual in participants with newly notified occupational hand eczema. Randomisation: Participants\r\nare centrally randomised according to a computer-generated allocation sequence with a varying block size concealed\r\nto investigators. Blinding: It is not possible to blind the participants and investigators, however, data obtained\r\nfrom registers, data entry, statistical analyses, and drawing of conclusions will be blinded. Outcomes: The three coprimary\r\noutcomes, assessed at 12 months, are: total number of self-reported days with sick leave; health-related quality\r\nof life; and subjective assessment of hand eczema severity. Explorative outcomes are: self-reported eczema-related\r\nsick leave, absence from work registered by the DREAM-register and by self-report, risk behaviour, knowledge of skin\r\nprotection and performance management (self-efficacy; and self-evaluated ability to self-care).\r\n(Continued on next page)
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