Protocol for a randomised trial on the effect of group education on skin-protective behaviour versus treatment as usual among individuals with newly notified occupational hand eczema - the Prevention of Hand Eczema (PREVEX) Trial

Maja Hvid Fisker, Tove Agner, Jane Lindschou, Jens Peter Bonde, Kristina Sophie Ibler, Christian Gluud, Per Winkel, Niels E Ebbehøj, Maja Hvid Fisker, Tove Agner, Jane Lindschou, Jens Peter Bonde, Kristina Sophie Ibler, Christian Gluud, Per Winkel, Niels E Ebbehøj

Abstract

Background: The incidence of occupational hand eczema is approximately 0.32 per 1,000 person years. The burden of the disease is high, as almost 60% has eczema-related sick leave during the first year after notification, and 15% are excluded from the workforce 12 years after disease onset. New treatments and prevention strategies are needed.

Trial design: The PREVEX trial is a randomised, parallel-group, superiority trial.

Participants: All individuals from the Capital Region of Denmark and Region Zealand with a suspected occupational skin disorder notified to the National Board of Industrial Injuries between June 2012 and December 2013 are invited to participate in the trial. Inclusion criteria are: self-reported hand eczema and informed consent. Exclusion criteria are: age <18 years or >65 years; permanent exclusion from the workforce; inability to understand the Danish language; any serious medical condition; and lack of written informed consent. We plan to randomise 742 participants.

Interventions: The experimental intervention is an educational course in skin-protective behaviour and written information about skin care related to the participants' specific occupation. Also, a telephone hotline is available and a subgroup will be offered a work-place visit. The experimental and the control group have access to usual care and treatment. All participants are contacted every eighth week with questions regarding number of days with sick leave or other absence from work. 12 months after randomisation follow-up is completed.

Objective: To assesses the effect of an educational course versus treatment as usual in participants with newly notified occupational hand eczema. Randomisation: PARTICIPANTS are centrally randomised according to a computer-generated allocation sequence with a varying block size concealed to investigators. Blinding: It is not possible to blind the participants and investigators, however, data obtained from registers, data entry, statistical analyses, and drawing of conclusions will be blinded.

Outcomes: The three co-primary outcomes, assessed at 12 months, are: total number of self-reported days with sick leave; health-related quality of life; and subjective assessment of hand eczema severity. Explorative outcomes are: self-reported eczema-related sick leave, absence from work registered by the DREAM-register and by self-report, risk behaviour, knowledge of skin protection and performance management (self-efficacy; and self-evaluated ability to self-care).

Discussion: The PREVEX trial will be the first individually randomised trial to investigate the benefits and harms of group-based education in patients with newly notified occupational hand eczema.

Trial registration: ClinicalTrials.gov Identifier: NCT01899287.

Figures

Figure 1
Figure 1
Trial flowchart.

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