A Randomised Clinical Trial on the Effect of Group Education on Patients With Occupational Hand Eczema — PREVEX  

Eczema Clinical Trial

Official title: A Randomised Clinical Trial on the Effect of Group Education on Skin-protective Behaviour Versus Treatment as Usual Among Individuals With Newly Notified Occupational Hand Eczema

Status Completed

Clinical Trial Summary

Occupational hand eczema (OHE) is a frequent disease which often takes a chronic course. The burden of the disease is high in a personal as well as in a socio-economic context. There is a need for evaluating new strategies to improve the prognosis for OHE patients. The objectives of the study is to evaluate the effect of group education on sick lave, health-related quality of life and disease severity among individuals with newly notified OHE.

The trial population consist of individuals from the Capital Region of Denmark and Region Zealand with a suspected skin-related industrial injury notified to the Danish National Board of Industrial Injuries (DNBII). Recruitment is started Juli 2012, and will continue until the designed number of participants have been included.

All participants will be assessed in a questionnaire at time T=0 with regard to: self evaluated disease severity, health-related quality of life, skin protective behaviour, knowledge of skin protection, self-efficacy, work-role function and if active in workforce. The participants will then be randomised. The intervention group will be invited to participate in the educative course, and work place visits will be offered. In the intervention group a telephone hot line will be available for further questions concerning these topics. The control group will not have access to any of these interventions. Both intervention group and control group will be contacted every eighth week about number of days of sick leave/absence from workforce. Both groups are re-assessed using a questionnaire at T=12 months. There will be a total of 742 included participants.

Clinical Trial Description

The hypotheses of the PREVEX trial are:

• Early information build on evidence-based skin-protection programmes and work-place visits with counselling in skin care, followed by telephone hotline, will give the participants increased level of knowledge concerning the treatment and prevention of OHE.

• Increased level of knowledge concerning prevention and focus on skin care will have a positive impact on skin-protective behaviour and will lower the severity of HE and prevent the development of chronic eczema.

• The decrease in severity of HE will decrease sick leave and keep the participants in job, or prevent job loss, or facilitate the re-entry into the workforce.

• In total, the intervention will have a positive effect on health-related quality of life. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Skin Conditions
• Skin Diseases

• NCT number: NCT01899287
• Study type: Interventional
• Source: University of Copenhagen
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Completion date: January 2014