Occupational Hand Eczema - Testing of a Prevention-concept

Study Overview
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Brief Summary
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Randomised controlled trial examining the effect of decreased waiting time for the first doctors' appointment, patient education, glove counselling and counselling at departments of social or occupational medicine on severity of hand eczema, quality of life, use of corticosteroids, and jobsituation 3-12 months after intervention in patients with suspected occupational contact dermatitis of the hands.

Detailed Description
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Patients with suspected occupational hand eczema are recruited to the study on basis of their referral from general practitioner to dermatologist. Patients are randomised to either control or intervention group. The control group is treated and followed-up by the dermatologist they have been referred to, while the intervention group is treated and followed-up at Gentofte Hospital skin department with a maximum waiting time of 3 weeks. At the skin department at Gentofte Hospital, the patients in the intervention group receive patient education in prevention and treatment of hand eczema, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. Patients in both the control and intervention group are asked to fill out a questionnaire at 3, 6, 9 and 12 months after inclusion in the study. The questionnaire contains questions about quality of life, severity of hand exzema, jobsituation, use of healthcare service and use of medicine. Furthermore, prescriptions of medicine are registered in both control and intervention group at 3, 6, 9 and 12 months.

Official Title
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Occupational Hand Eczema - Establishment and Testing of a Prevention-concept With Focus on the Young Workforce

Conditions
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Occupational Contact Dermatitis

Intervention / Treatment
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* Other: Treatment at the skin department at Gentofte Hospital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred from a general practitioner to a dermatologist Hand eczema within the last 3 months Suspicion that the hand eczema is work-related (either patient and/or doctors suspicion) Exclusion Criteria: Does not read and write danish Severe psychiatric illness Pregnancy

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Treatment in a hospital setting at Gentofte Hospital skin department with patient education, glove counselling, personal product screening by a chemistry engineer, extended allergy testing and the standard treatment of hand eczema. | Other: Treatment at the skin department at Gentofte Hospital<br>* Treatment in a hospital setting at Gentofte Hospital skin department<br>|
| No Intervention: Control group<br>Treatment as usual (at a dermatologist office). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst) | The hand eczema severity index (HECSI) | Change between baseline and 3 months | 
| Change in severity of handeczema assessed by the photographic guide for severity of handeczema | Self-assessed photographic guide | Change between baseline and 3 months | 
| Change in severity of handeczema assessed by the photographic guide for severity of handeczema | Self-assessed photographic guide | Change between baseline and 6 months | 
| Change in severity of handeczema assessed by the photographic guide for severity of handeczema | Self-assessed photographic guide | Change between baseline and 9 months | 
| Change in severity of handeczema assessed by the photographic guide for severity of handeczema | Self-assessed photographic guide | Change between baseline and 12 months | 
| Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst) | Visual analog Score for severity of handeczema | Change between baseline and 3 months | 
| Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst) | Visual analog Score for severity of handeczema | Change between baseline and 6 months | 
| Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst) | Visual analog Score for severity of handeczema | Change between baseline and 9 months | 
| Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst) | Visual analog Score for severity of handeczema | Change between baseline and 12 months | 
| Amount of corticosteroids prescribed within the last year | Amount of corticosteroids prescribed wihtin the last year | Baseline | 
| Amount of corticosteroids prescribed within the last 3 months | Amount of corticosteroids prescribed within the last 3 months | 3 months | 
| Amount of corticosteroids prescribed within the last 3 months | Amount of corticosteroids prescribed within the last 3 months | 6 months | 
| Amount of corticosteroids prescribed within the last 3 months | Amount of corticosteroids prescribed within the last 3 months | 9 months | 
| Amount of corticosteroids prescribed within the last 3 months | Amount of corticosteroids prescribed within the last 3 months | 12 months | 
| Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life) | Skindex-29 | Baseline | 
| Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life) | Skindex-29 | 3 months | 
| Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life) | Skindex-29 | 6 months | 
| Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life) | Skindex-29 | 9 months | 
| Health-Related Quality of Life assessed by Skindex-29, scale ranging from 0-100 points (higher score = higher impact of skin disease on quality of life) | Skindex-29 | 12 months | 
| Health-Related Quality of Life assessed by European Quality of Life - 5 Dimensions (EQ-5D) | European Quality of Life - 5 Dimensions (EQ-5D) | Baseline | 
| Health-Related Quality of Life assessed by European Quality of Life - 5 Dimensions (EQ-5D) | European Quality of Life - 5 Dimensions (EQ-5D) | 3 months | 
| Health-Related Quality of Life assessed by European Quality of Life - 5 Dimensions (EQ-5D) | European Quality of Life - 5 Dimensions (EQ-5D) | 6 months | 
| Health-Related Quality of Life assessed by European Quality of Life - 5 Dimensions (EQ-5D) | European Quality of Life - 5 Dimensions (EQ-5D) | 9 months | 
| Health-Related Quality of Life assessed by European Quality of Life - 5 Dimensions (EQ-5D) | European Quality of Life - 5 Dimensions (EQ-5D) | 12 months | 
| Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life) | Dermatology life quality index (DLQI) | Baseline | 
| Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life) | Dermatology life quality index (DLQI) | 3 months | 
| Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life) | Dermatology life quality index (DLQI) | 6 months | 
| Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life) | Dermatology life quality index (DLQI) | 9 months | 
| Health-Related Quality of Life assessed by Dermatology life quality index (DLQI) 0-30 (higher score = higher impact of skin disease on quality of life) | Dermatology life quality index (DLQI) | 12 months | 
| Number of participants with loss of job within the last year | Self-repported loss of job wihtin the last year | Baseline | 
| Number of participants with loss of job within the last 3 months | Self-repported loss of job within the last 3 months | Baseline | 
| Number of participants with loss of job within the last 3 months | Self-repported loss of job within the last 3 months | 3 months | 
| Number of participants with loss of job within the last 3 months | Self-repported loss of job within the last 3 months | 6 months | 
| Number of participants with loss of job within the last 3 months | Self-repported loss of job within the last 3 months | 9 months | 
| Number of participants with loss of job within the last 3 months | Self-repported loss of job within the last 3 months | 12 months | 
| Amount of sick leave within the last year | Self-repported amount of sick leave within the last year | Baseline | 
| Amount of sick leave within the last 3 months | Self-repported amount of sick leave within the last 3 months | 3 months | 
| Amount of sick leave within the last 3 months | Self-repported amount of sick leave within the last 3 months | 6 months | 
| Amount of sick leave within the last 3 months | Self-repported amount of sick leave within the last 3 months | 9 months | 
| Amount of sick leave within the last 3 months | Self-repported amount of sick leave within the last 3 months | 12 months | 
| Number of participants with change of occupation due to occupational contact dermatitis within the last year | Change of occupation due to occupational contact dermatitis within the last year | Baseline | 
| Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months | Change of occupation due to occupational contact dermatitis within the last 3 months | 3 months | 
| Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months | Change of occupation due to occupational contact dermatitis within the last 3 months | 6 months | 
| Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months | Change of occupation due to occupational contact dermatitis within the last 3 months | 9 months | 
| Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months | Change of occupation due to occupational contact dermatitis within the last 3 months | 12 months |