Skip to content

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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01899287
Acronym
PREVEX
Enrollment
770
Registered
2013-07-15
Start date
2012-07-31
Completion date
2014-01-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eczema, Skin Conditions

Keywords

workers education, occupational

Brief 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. .

Detailed 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.

Interventions

BEHAVIORALgroup education

The experimental intervention consists of: A. Group education on general skin-protective behaviour. B. Group education and counselling on work-related skin-protective behaviour, which might extend to a work-place visit. C. Social guidance related to OHE. D. Telephone hot-line for work and case-related problems, maintained by nurse.

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Self-reported HE, i.e., individuals answering 'yes' in the questionnaire to the question 'Have you or have you had hand eczema?' * The questionnaire is sufficiently filled in with respect to 'severity of HE' and 'profession'. * Written informed consent.

Exclusion criteria

* Age below 18 years or above 65 years. * Permanently excluded from the workforce. * Inability to understand the Danish language sufficiently to benefit from the course. * Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results. * Lack of written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Sick leave1 year• Total sick leave; measured as self-reported number of days with sick leave during the trial period.
Health-related quality of life1 yearHealth-related quality of life; measured as points scored in the Dermatology Life Quality Index (DLQI) at 12 months after inclusion. •
Disease severity1 yearSubjective assessment of hand eczema severity; measured by use of a photographic guide at 12 months after inclusion.

Secondary

MeasureTime frameDescription
eczema-related sick leave1 yearThe following outcomes will be assessed as explorative, as there is insufficient information to conduct power calculations. * Eczema-related sick leave; measured as self-reported number of days with eczema-related sick leave during the trial period. * Absence registered by the DREAM-register; only absence for more than 28 days from workplace is registered here. This will be done at T=12 months. We will measure absence from work because of sick leave for more than 21 days , yes or no. * Behaviour measured as number of points achieved in a questionnaire concerning both occupational and private risk behaviour at time T=12. * Knowledge of skin protection measured as numbers of points achieved in a multiple choice questionnaire at time T=12 months. * Performance management at time T=12 months of the participant measured by the number of points achieved in: * Self-efficacy; and * Self-evaluated ability to self-care.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026