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| Name | Class |
|---|---|
| The Danish Working Environment Authority | UNKNOWN |
| Region Zealand | OTHER |
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Objectives and perspective:
The overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers.
Hypotheses:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand Eczema in health care workers | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A randomised clinical trial of the effect of classification and individual counselling | Behavioral | The trial to be conducted is a randomised single-blinded parallel study. It is divided in two stages, T = 0 and follow-up at T = 6 months. All included participants will have a clinical examination at the beginning and at follow-up in the trial. Half of the participants will be randomised to intervention, the other half to control. The participants in the intervention group will, after the first clinical examination, pass on directly to the intervention which includes an allergological examination (patch and prick testing). Three days later they will be examined by a physician who will interpret the patch test and give a thorough, individual guidance in skin protection and occupational safety. The clinical examination of all participants at follow-up will reveal the difference in outcomes in the intervention and the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes: -Subjective assessment of disease severity (HE) -Number of eruptions through the past three months -Knowledge of skin protection -Skinprotective behaviour -Quality of life | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Sophie Ibler, MD, Ph.d-student | Contact | +45-47322600 | ksi@regionsjaelland.dk | |
| Tove Agner, MD, DM Science | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holbaek Hospital | Not yet recruiting | Holbæk | 4300 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23236031 | Derived | Ibler KS, Jemec GB, Diepgen TL, Gluud C, Lindschou Hansen J, Winkel P, Thomsen SF, Agner T. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial. BMJ. 2012 Dec 12;345:e7822. doi: 10.1136/bmj.e7822. | |
| 20807407 | Derived | Ibler KS, Agner T, Hansen JL, Gluud C. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema. BMC Dermatol. 2010 Aug 31;10:8. doi: 10.1186/1471-5945-10-8. |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Koege Hospital | Not yet recruiting | Koege | 4600 | Denmark |
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| Dermatological Department, Roskilde County Hospital | Recruiting | Roskilde | 4000 | Denmark |
|