Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial

Kristina Sophie Ibler, Gregor B E Jemec, Thomas L Diepgen, Christian Gluud, Jane Lindschou Hansen, Per Winkel, Simon Francis Thomsen, Tove Agner, Kristina Sophie Ibler, Gregor B E Jemec, Thomas L Diepgen, Christian Gluud, Jane Lindschou Hansen, Per Winkel, Simon Francis Thomsen, Tove Agner

Abstract

Objective: To evaluate the effect of a secondary prevention programme with education on skin care and individual counselling versus treatment as usual in healthcare workers with hand eczema.

Design: Randomised, observer blinded parallel group superiority clinical trial.

Setting: Three hospitals in Denmark.

Participants: 255 healthcare workers with self reported hand eczema within the past year randomised centrally and stratified by profession, severity of eczema, and hospital. 123 were allocated to the intervention group and 132 to the control group.

Interventions: Education in skin care and individual counselling based on patch and prick testing and assessment of work and domestic related exposures. The control was treatment as usual.

Main outcome measures: The primary outcome was clinical severity of disease at five month follow-up measured by scores on the hand eczema severity index. The secondary outcomes were scores on the dermatology life quality index, self evaluated severity of hand eczema, skin protective behaviours, and knowledge of hand eczema from onset to follow-up.

Results: Follow-up data were available for 247 of 255 participants (97%). At follow-up, the mean score on the hand eczema severity index was significantly lower (improved) in the intervention group than control group: difference of means, unadjusted -3.56 (95% confidence interval -4.92 to -2.14); adjusted -3.47 (-4.80 to -2.14), both P<0.001 for difference. The mean score on the dermatology life quality index was also significantly lower (improved) in the intervention group at follow-up: difference of means: unadjusted -0.78, non-parametric test P=0.003; adjusted -0.92, -1.48 to -0.37). Self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves were also statistically significantly better in the intervention group, whereas this was not the case for knowledge of hand eczema.

Conclusion: A secondary prevention programme for hand eczema improved severity and quality of life and had a positive effect on self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves.

Trial registration: ClinicalTrials.gov NCT01012453.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: GBJ is on the advisory board of Abbott Laboratories and Pfizer, Coloplast and Leo Pharma, in speakers bureau of Galderma and Novartis, and investigator of Actelion, Janssen Pharma and Abbott Laboratories. TD has been a consultant for Spirig Pharma, Basilea Pharmaceutica, Firmenich, Novartis, Procter & Gamble, and Evanik Industries, and in the speakers bureau of Actelion Pharmaceuticals, Almirall, Basilea Pharmaceutica, Leo Pharma, Spirig Pharma, and Astellas. TA is in the speakers bureau of Abbott, Basilea Pharmaceutica, and Leo Pharma. KSI, CG, JLH, PW, and SFT have no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4790597/bin/iblk002838.f1_default.jpg
Trial flow chart

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