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Open Access Study protocol

The Hand Eczema Trial (HET): design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema

Kristina Sophie Ibler1*, Tove Agner2, Jane Lindschou Hansen3 and Christian Gluud4

Author Affiliations

1 Department of Dermatology, Roskilde Hospital, Roskilde, Denmark

2 Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark

3 MSc Demography and Health, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen, Denmark

4 Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen, Denmark

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BMC Dermatology 2010, 10:8  doi:10.1186/1471-5945-10-8

Published: 31 August 2010

Abstract

Background

Hand eczema is the most frequently recognized occupational disease in Denmark with an incidence of approximately 0.32 per 1000 person-years. Consequences of hand eczema include chronic severe eczema, prolonged sick leave, unemployment, and impaired quality of life. New preventive strategies are needed to reduce occupational hand eczema.

Methods/Design

We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease severity (Hand Eczema Severity Index); self-evaluated disease severity; number of eruptions; quality of life; skin protective behaviour, and knowledge of skin protection. The patients are centrally randomised to intervention versus no intervention 1:1 stratified for hospital, profession, and severity score. The experimental group undergoes patch and prick testing; classification of the hand eczema; demonstration of hand washing and appliance of emollients; individual counselling, and a skin-care programme. The control group receives no intervention. All participants are reassessed after six months. The primary outcome is observer-blinded assessment of disease severity and the secondary outcomes are unblinded assessments of disease severity; number of eruptions; knowledge of skin protection; skin-protective behaviour, and quality of life.

Trial registration

The trial is registered in ClinicalTrials.Gov, NCT01012453.