An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quality of Life Improvement
研究概览
简要总结
To evaluate the effect on quality of life of consumers with self-reported onychomycosis during the first 4 weeks of treatment in relation to the appearance of the infected toenail.
详细描述
The appearance of the infected toe nail in those suffering from the disease may have a greater impact on quality of life than the severity of the disease. It is believed that a visual improvement in the appearance of the infected toenail at an earlier stage could have a positive impact on quality of life and encourage compliance with treatment. The aim of this consumer study is to evaluate the quality of life of consumers with onychomycosis and investigate its relation to the appearance of the infected toenail within the initial 4 weeks of treatment with Scholl Fungal Nail following its purchase from an eCommerce platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Consumers who have purchased the product online
- •Consumers who are willing to participate in the study
排除标准
- •Female consumers who are pregnant or breast feeding
- •Participants with Diabetes (Type I or II)
结局指标
主要结局
Quality of Life Improvement
时间窗: 28 days
Change in mean total score of the OnyCOE-t™ from baseline to end of inital treatment period. The domains are transformed into 0-100 scale where higher scores indicate better functioning. Changes from baseline of the mean total score will be evaluated with repeated measures t-tests. The questionnaire contains 7 domains: 7-item Toenail Symptoms, containing Symptom Frequency (5 categories: 1 = never, 5 = very often) and Symptom Bothersomeness (5 categories: 1 = not at all bothered, 5 = extremely bothered) 8-item Appearance Problems (4 categories: 1 = very much a problem, 4 = not a problem) 7-item Physical Activities Problems (4 categories: 1 = very much a problem, 4 = not a problem) 1-item Overall Problem (4 categories; 1 = very much a problem, 4 = not a problem) 7-item Stigma (5 categories: 0 = does not describe me at all, 4 = describes me very well) 3-item Treatment Satisfaction scale (5 categories: 1 = very satisfied, 5 very dissatisfied)
次要结局
- Participant perception of the improvement in colour of their infected toenail.(Any timepoint up to day 28)
- Individual OnyCOE-t(TM) domain improvement(28 days)
- Participant perception of the improvement in healthy appearance of their infected toenail.(Any timepoint up to day 28)
- Participant perception of improvement in brightness of their infected toenail.(Any timepoint up to day 28)
- Participant perception of the improvement in smoothness of their infected toenail.(Any timepoint up to day 28)
- Participant perception of improvement of their feelings of embarrassment associated with their infected toenail.(Any timepoint up to day 28)