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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.
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The hypotheses of the PREVEX trial are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| education in skin care | Experimental | 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. |
|
| no intervention | No Intervention | The control group will not have access to the group education, the profession specific information and the social guidance or the telephone hotline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sick leave | • Total sick leave; measured as self-reported number of days with sick leave during the trial period. | 1 year |
| Health-related quality of life | Health-related quality of life; measured as points scored in the Dermatology Life Quality Index (DLQI) at 12 months after inclusion. • | 1 year |
| Disease severity | Subjective assessment of hand eczema severity; measured by use of a photographic guide at 12 months after inclusion. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| eczema-related sick leave | The following outcomes will be assessed as explorative, as there is insufficient information to conduct power calculations.
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24245553 | Derived | Fisker MH, Agner T, Lindschou J, Bonde JP, Ibler KS, Gluud C, Winkel P, Ebbehoj NE. 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. BMC Dermatol. 2013 Nov 19;13:16. doi: 10.1186/1471-5945-13-16. |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| 1 year |