Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Effectiveness of a novel educational program on the quality of life and the clinical outcome.
研究概览
简要总结
'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent) for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to actively participate in their therapeutic approach by enhanced self care. We call the hypothesis that this program will help the patients learn to cope with their disease and to be loyal to their treatment, which will result in a better quality of life, better clinical outcome and cost effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given written informed consent
- •Women or men of any race
- •Patients who are 18-75 years of age
- •Diagnosis of psoriasis or atopic dermatitis
排除标准
- •Patients with a cognitive disorder (not able to understand, speak, read or write..)
- •Patients with a significant underlying medical cause (i.e. severe infection, haematologic disease, malignity, severe renal or hepatic disease, major depression) in the last 3 months
- •Patients under experimental pharmaceutical medication
结局指标
主要结局
Effectiveness of a novel educational program on the quality of life and the clinical outcome.
时间窗: At 12 weeks, after 6 and 9 months
Therefore quality of life questionnaires are completed at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months. The quality of life questionnaires are Daily life quality index, Skindex 29, EuroQol -5D, Short Form - 36 , Psoriasis disability index, Quality of Life Index for Atopic Dermatitis. The clinical effectiveness is determined by measuring psoriasis area and severity index (PASI) or scoring atopic dermatitis (SCORAD) at the beginning of the program, at the end of the program (12 weeks), after 6 months and after 9 months.
次要结局
- Depression severity(At 12 weeks, 6 months and 9 months)
- Lifestyle(At 12 weeks, 6 months and 9 months)
- Medical consumption and cost-effectiveness evaluation(At 12 weeks, 6 months and 9 months)