Mollerup Annette, Veien Niels Kren, Johansen Jeanne Duus
National Allergy Research Centre, Copenhagen University Hospital Gentofte, Gentofte, Denmark.
BMC Dermatol. 2012 Jun 12;12:6. doi: 10.1186/1471-5945-12-6.
Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual's daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed.
METHODS/DESIGN: This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named 'The Healthy Skin Clinic' or to the control group. Block-wise randomisation according to setting and gender is carried out.The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease.
The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as well of potential observer bias. Inclusion criterions are wide in order to increase transferability of the results.
The trial is registered in ClinicalTrials.Gov with registration number NCT01482663.
手部湿疹在丹麦普通人群中的一年患病率约为10%。该疾病常转为慢性，对个人日常生活、职业和生活质量有诸多影响。然而，目前尚无急性期之后自我管理建议的指南。疾病的自我管理至关重要，包括病情自我监测、药物依从性和预防行为。需要开发最佳干预措施以支持个体在这一持续过程中进行自我管理。
方法/设计：本文描述了一项随机临床试验的设计，以测试新开发的个体咨询干预措施与传统信息干预措施的效果。连续在两个不同机构接受皮肤科治疗的300名患者被随机分为干预组（名为“健康皮肤诊所”）或对照组。根据机构和性别进行区组随机化。干预措施提供了一个自我监测工具；基础和特定的个体咨询；与干预团队进行异步沟通的可能性；以及一个电子患者对话论坛。主要结局变量是在随机分组前基线时对手部湿疹严重程度进行的客观评估，并在六个月随访时重复评估。次要结局变量是与皮肤科相关的生活质量和感知的总体疾病负担。
该试验旨在评估一项新开发的指导计划，该计划有望支持因慢性手部湿疹而接受皮肤科治疗的患者进行自我管理。方案设计较为务实，参与者和研究者均不设盲。因此，在解释结果时，研究者会考虑可能归因于干预措施实施者的影响，而非干预措施本身，以及潜在的观察者偏倚。纳入标准宽泛，以提高结果的可推广性。
该试验已在ClinicalTrials.Gov注册，注册号为NCT01482663。
