NCT01012453Unknown不适用
Hand Eczema Trial: A Randomised Clinical Trial of the Effect of Classification and Individual Counselling Among Health Care Workers With Hand Eczema
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
研究概览
简要总结
Objectives and perspective:
- To estimate the prevalence of hand eczema in a cohort of health care workers and assess exposures in the hospital environment that can lead to hand eczema . To investigate the knowledge of skin protection among health care workers.
- To classify subtypes of hand eczema, assess severity of hand eczema and quality of life in health care workers with hand eczema
- To evaluate the effect of a combination of classification of hand eczema and individual work-related counseling in skin protective behavior.
The overall perspective of the trial is to develop new strategies for prevention of occupational hand eczema in health care workers.
Hypotheses:
- Irritant contact dermatitis is more common than allergic contact dermatitis.
- The combination of precise classification (subtyping of HE) and individual counseling will have a positive impact on the prognosis of hand eczema.
- The positive impact on the prognosis of hand eczema will have a positive impact on quality of life (QoL).
- The knowledge of protective behavior will increase.
- Education in a skin care program will have a positive impact on skin protective behavior.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be recruited on the basis of the results from the questionnaire investigation of 3,181 HCW in three Danish hospitals in the same region. Participants who have answered "yes" to the validated question "Have you had hand eczema within the past twelve months?" will be invited to take part in the clinical trial.
- •Informed written consent must be present in order to participate.
排除标准
- •Pregnancy
- •Systemic use of immunosuppressive drugs
- •Systemic use of retinoids
- •Active psoriatic lesions on the hands
- •Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
- •Lack of informed written consent
结局指标
主要结局
Primary outcome: Objective assessment of disease severity (HE), measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
时间窗: 6 months
次要结局
- 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)
研究者
研究点 (6)
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