Chronic Hand Eczema - Self-management and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 4
- 主要终点
- Hand Eczema Severity Index (HECSI)
研究概览
简要总结
Hand eczema is a common disease which often gives a chronic course thus affecting many functions in daily life. The body of evidence related to self-management of chronic hand eczema is poor. Better methods to support self-management of patients with chronic hand eczema may potentially improve the prognosis of a disease which is both a tremendous burden to the individual and to the society. The purpose of this trial is to evaluate the effect of a newly designed guidance programme offering individual counselling compared to conventional information with written information sheets.
详细描述
Detailed description of the trial and the intervention can be found in the publication:
Mollerup A, Veien NK, Johansen JD. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial'. BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.
PMID: 22691871 [PubMed - indexed for MEDLINE] Free PMC Article
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with hand eczema at the first medical consultation at the outpatient ward, Copenhagen University Hospital Gentofte or at a private dermatologic practise in Aalborg, Denmark
- •Patients who have given a signed informed consent to participate
排除标准
- •Patients who cannot reply to a questionnaire in Danish
结局指标
主要结局
Hand Eczema Severity Index (HECSI)
时间窗: 6 months
Objective assessment of disease severity, measured by HECSI-score at time = 6 months versus HECSI-score at time = 0.
次要结局
- Dermatology Life Quality Index (DLQI)(6 months)
- Overall burden of disease (VAS)(6 months)
- Danish version of The Medication Adherence Report Scale (DMARS-4)(6 months)
研究者
Annette Mollerup
MScHealth, PhD-student
University Hospital, Gentofte, Copenhagen