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.
調査の概要
研究の種類
観察的
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：12 weeks
|
EASI measures the severity and body surface area of eczema on a scale from 0-72.
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Personalized DNA lifestyle reports/information reports as an engagement tool in clinical trials
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correlation between environmental factors and AD flare ups
時間枠：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
時間枠：12 weeks
|
Number of days on a weekly cycle of patient-use of medication/treatment
|
12 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Justin M Ko, MD, MBA、study principal investigator
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年11月30日
一次修了 (予想される)
2021年12月31日
研究の完了 (予想される)
2021年12月31日
試験登録日
最初に提出
2021年6月30日
QC基準を満たした最初の提出物
2021年7月15日
最初の投稿 (実際)
2021年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月20日
QC基準を満たした最後の更新が送信されました
2021年9月13日
最終確認日
2021年9月1日
詳しくは
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