Occupational Hand Eczema - Establishment and Testing of a Prevention-concept With Focus on the Young Workforce
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Does not read and write danish
- •Severe psychiatric illness
- •Pregnancy
结局指标
主要结局
Change in severity of handeczema assessed by the hand eczema severity index (HECSI) 0-360 points (0 best, 360 worst)
时间窗: Change between baseline and 3 months
The hand eczema severity index (HECSI)
Number of participants with loss of job within the last year
时间窗: Baseline
Self-repported loss of job wihtin the last year
Change in severity of handeczema assessed by the photographic guide for severity of handeczema
时间窗: Change between baseline and 12 months
Self-assessed photographic guide
Amount of corticosteroids prescribed within the last 3 months
时间窗: 12 months
Amount of corticosteroids prescribed within the last 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)
时间窗: 12 months
Skindex-29
Change in severity of handeczema assessed by a visual analog score 0-100 (0 best, 100 worst)
时间窗: Change between baseline and 12 months
Visual analog Score for severity of handeczema
Amount of corticosteroids prescribed within the last year
时间窗: Baseline
Amount of corticosteroids prescribed wihtin the last year
Health-Related Quality of Life assessed by "European Quality of Life - 5 Dimensions" (EQ-5D)
时间窗: 12 months
"European Quality of Life - 5 Dimensions" (EQ-5D)
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)
时间窗: 12 months
Dermatology life quality index (DLQI)
Number of participants with loss of job within the last 3 months
时间窗: 12 months
Self-repported loss of job within the last 3 months
Amount of sick leave within the last 3 months
时间窗: 12 months
Self-repported amount of sick leave within the last 3 months
Number of participants with change of occupation due to occupational contact dermatitis within the last year
时间窗: Baseline
Change of occupation due to occupational contact dermatitis within the last year
Amount of sick leave within the last year
时间窗: Baseline
Self-repported amount of sick leave within the last year
Number of participants with change of occupation due to occupational contact dermatitis within the last 3 months
时间窗: 12 months
Change of occupation due to occupational contact dermatitis within the last 3 months
次要结局
未报告次要终点
研究者
Jojo Biel-Nielsen Dietz
Medical doctor, Ph.d.-student
National Allergy Research Center, Denmark