Hidradenitis Suppurativa Mail Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Ability of HSSA to detect changes in disease severity over time
研究概览
简要总结
Hidradenitis Suppurativa (HS), also known as "acne inversa," is a chronic dermatologic disease affecting apocrine gland-bearing areas and presenting with symptoms ranging from pustules and inflammatory nodules to draining sinuses, abscesses, and fistulae. The pain and odorous lesions associated with HS contribute to its heightened impact on quality of life in comparison to other diseases; it has been described as "one of the most distressing conditions observed in dermatology." Though it is clear that HS has a significant impact on quality of life, how this manifests remains poorly characterized. The aim of this study is to characterize the quality of life impact of HS and to validate a tool for patients to self-assess the severity of their condition.
详细描述
Running a comprehensive study and asking patients what challenges they encounter in their daily lives can shed light on the ways in which HS causes quality of life impairment. In this study, the study team aims to identify the following: problems faced by patients with HS, the rate of depression, the rate of stigmatization, the rate of fear of being accepted in society, treatments that patients have tried (and which treatments seem to have worked best), the rate of alternative treatment use, and the correlation of these factors with the severity of disease.
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
- •Patients diagnosed with Hidradenitis Suppurativa by a dermatologist at Wake Forest Baptist Medical Center's dermatology clinic.
- •Patients 18 years of age or older
排除标准
- •Patients younger than 18 years of age
- •Any patient who does not have a mailing address on file
结局指标
主要结局
Ability of HSSA to detect changes in disease severity over time
时间窗: 1 day
For those patients who are recruited in person, when they come back to the clinic for follow-up, the HSSA will be administered again. The physician will also provide an assessment of severity. These will be compared to the original physician assessment and HSSA result to determine the ability of the HSSA to detect changes in disease severity over time.
Comparison of self-assessed severity to physician-assessed severity of HS
时间窗: 1 day
Participants will be administered a 2-page survey with photographs of HS in varying degrees of severity (Hidradenitis Suppurativa Self-Assessment tool, or HSSA) and asked to check the photo(s) that represent their condition now and when it was the worst it has ever been. The photos correspond with severity levels 0 (no disease), 1, 2, and 3 according to the Hurley Staging system (a commonly used system to evaluate severity of HS). Physicians will also assess the Hurley severity of disease when they see the patient. Agreement between physician severity assessment and self assessment will be measured.
Test-retest reliability of self-assessed severity of HS
时间窗: 1 day
Participants will be administered a 2-page survey with photographs of HS in varying degrees of severity and asked to check the photo(s) that represent their condition now and when it was the worst it has ever been. The photos correspond with severity levels 0 (no disease), 1, 2, and 3 according to the Hurley Staging system (a commonly used system to evaluate severity of HS). At least 30 minutes later, participant's will re-do the HSSA. Agreement between the original and second response will be assessed to establish test-retest reliability of the tool.
次要结局
- Emotional Stability as measured by PANAS (Positive and Negative Affect Schedule)(1 day)
- Stigmatization as measured by an adaptation of Ginsburg and Link Feelings of Stigmatization(1 day)
- Quality of life as measured by DLQI(1 day)
- Depression as measured by PHQ-9(1 day)
- Quality of life as measured by HiSQoL(1 day)
- Quality of life as measured by RAND-36(1 day)
- Fear of Negative Evaluation(1 day)