Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes
2021年9月13日 更新者：Studies&Me
Atopic eczema is a common skin disorder affecting at least 2-3% of the western population.
Atopic eczema cannot be cured and therefore treatment aims to alleviate the symptoms of the disease.
Today, many different medical treatments are available: from mild hormone creams to harsh systemic treatments.
The treatment chosen depends in part on the severity of the eczema and on the treatment response of the individual.
This practice may mean that some people with eczema undergo unnecessary treatment courses with associated side effects.
We know today that eczema has a hereditary component, and different areas have been identified in the hereditary material that appear to play a role.
Although it is thought that variations in specific areas of the inheritance material may influence how eczema is expressed in the individual, the significance of these variations is far from clarified.
The investigators want to increase the knowledge about atopic eczema, about the disease and how in the future we can organize the treatment of eczema based on knowledge of our genetic material.
In this study, the investigators want to elucidate whether there is a correlation between specific variations in the genetic material and how the eczema is clinically expressed.
In addition, the investigators want to assess whether reports with specific information about the individual's genetic material in relation to his or her lifestyle can help retain participants in research projects.
研究概览
研究类型
观察性的
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
Recruitment is performed through the Studies&Me platform (https://studiesandme.com/), which is recruiting and screening people with AD, who are generally interested in participating in a study related to their disease.
Participants will also be recruited through clinics and hospitals.
描述
Inclusion Criteria:
- Informed consent has been signed
- 18 years or older
- Resident in the USA or Denmark
- AD meeting the UK Diagnostic Criteria for Atopic Dermatitis
- At least one visible AD lesion at the time of recruitment (as confirmed remotely through photo upload in screening)
- Smartphone user with daily access to internet (WIFI or 3G/4G)
- Willing to donate a DNA sample
- Confirmed intention to comply with study protocol procedures
Exclusion Criteria:
- Female subjects that are pregnant (or plan to become so during the study period) or lactating
- Active dermatological condition that may confound the diagnosis of AD and/or the assessment of disease activity
- Unable to speak or understand English or Danish
- Overlap with participation in interventional trials
- No visible AD at time of screening
- Any other reasons that in the investigator's opinion could:
- Impede a subject's ability to complete the study period
- Influence the objectivity or quality of the findings of the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Participants recruited in Denmark
Participants recruited in Denmark will consist of 63 healthy individuals and 187 individuals with atopic dermatitis
|
Reports containing general information on eczema
|
|
Participant recruited in the United States of America
Participants recruited in the US will consist of 125 healthy individuals, 3000 individuals with atopic dermatitis
|
The personalized DNA lifestyle reports cover the following topics: Healthy weight, Vitamin D, Alcohol, Lactose, Injuries, Caffeine, Fitness, Carbohydrates, The mind, Vitamin B, The senses, and Omega.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the SCORing Atopic Dermatitis (SCORAD) evaluated remotely through photos by investigator assessment.
大体时间：12 weeks
|
SCORAD measures the severity of eczema on a scale from 0-103.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Three Item Severity Score (TIS) evaluated remotely through photos by investigator assessment.
大体时间：12 weeks
|
TIS measures the severity of erythema, oedema/papulation and excoriation on a scale from 0-9.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema Area and Severity Index (EASI) evaluated remotely through photos by investigator assessment.
大体时间：12 weeks
|
EASI measures the severity and body surface area of eczema on a scale from 0-72.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the The Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)) evaluated remotely through photos by investigator assessment.
大体时间：12 weeks
|
vIGA-AD measures the severity of eczema on a scale from 0-4.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient Oriented Eczema Measurement (POEM) questionnaire.
大体时间：12 weeks
|
POEM measures the severity of eczema as experienced by the patient on a scale from 0-28.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Skindex-mini questionnaire.
大体时间：12 weeks
|
Skindex-mini measures the symptomatic, emotional and functional aspects of an individual's skin disorder on a scale from 0-18.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Patient's Global Impression of Severity Numerical Rating System (PGIS-NRS) questionnaire.
大体时间：12 weeks
|
PGIS-NRS measures the impression of severity of an individual's skin disorder on a scale from 0-10.
|
12 weeks
|
|
Change in AD phenotype measured on a weekly basis for 12 weeks using the Eczema-related sleep quality NRS questionnaire.
大体时间：12 weeks
|
Eczema-related sleep quality NRS measures the sleep quality, itch and dryness on a scale from 0-10.
|
12 weeks
|
|
Change in AD phenotype measured by patient-perceived flare ups on a weekly basis for 12 weeks.
大体时间：12 weeks
|
Number of days on a weekly basis with flare ups.
|
12 weeks
|
|
Change in AD phenotype measured by the disease extent method on a weekly basis for 12 weeks.
大体时间：12 weeks
|
Palm method to measure AD affected body surface area (0-100%).
|
12 weeks
|
|
Change in AD phenotype measured by the Eczema Area and Severity Index (EASI) on a weekly basis for 12 weeks.
大体时间：12 weeks
|
EASI measures the severity and body surface area of eczema on a scale from 0-72.
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
大体时间：12 weeks
|
Number of completers receiving DNA lifestyle reports/information reports at different time points will be compared to evaluate effect on retention.
|
12 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between environmental factors and AD flare ups
大体时间：12 weeks
|
Passive data on geographical localisation, daily activity level and an approximation for length of sleep
|
12 weeks
|
|
Number of days on a weekly cycle of patient-use of medication/treatment
大体时间：12 weeks
|
Number of days on a weekly cycle of patient-use of medication/treatment
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Justin M Ko, MD, MBA、study principal investigator
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年11月30日
初级完成 (预期的)
2021年12月31日
研究完成 (预期的)
2021年12月31日
研究注册日期
首次提交
2021年6月30日
首先提交符合 QC 标准的
2021年7月15日
首次发布 (实际的)
2021年7月16日
研究记录更新
最后更新发布 (实际的)
2021年9月20日
上次提交的符合 QC 标准的更新
2021年9月13日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.