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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 770
- 试验地点
- 2
- 主要终点
- Disease severity
研究概览
简要总结
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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详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Disease severity
时间窗: 1 year
Subjective assessment of hand eczema severity; measured by use of a photographic guide at 12 months after inclusion.
Sick leave
时间窗: 1 year
• Total sick leave; measured as self-reported number of days with sick leave during the trial period.
Health-related quality of life
时间窗: 1 year
Health-related quality of life; measured as points scored in the Dermatology Life Quality Index (DLQI) at 12 months after inclusion. •
次要结局
- eczema-related sick leave(1 year)
研究者
Tove Agner
professor
University of Copenhagen