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临床试验/NCT05621369
NCT05621369进行中(未招募)不适用

Psorcast Study: A Smartphone-based Study of Psoriasis and Psoriatic Arthritis

Sage Bionetworks2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
2
主要终点
Results of participant self-assessment surveys

研究概览

简要总结

The purpose of this study is to understand variation in the symptoms of psoriasis and psoriatic arthritis using simple, scalable smartphone-based measurements. This study uses an iPhone app to record these symptoms through questionnaires and sensors.

详细描述

Psoriatic disease exhibits a spectrum of symptoms and can transition from psoriasis (PsO), largely affecting the skin, to psoriatic arthritis (PsA) involving widespread musculoskeletal inflammation. Early detection of the PsO-to-PsA transition and rapid administration of effective treatment is essential, as a delay in diagnosing PsA by as little as 6 months can lead to irreversible joint damage. This "ticking clock" paradigm drives the need for frequent monitoring and effective therapeutic intervention as early as possible to attenuate or possibly prevent disease progression. Using a suite of smartphone-based measurements in an app called Psorcast (psoriasis forecasts), we aim to aggregate weekly, symptom measurements from participants in a remote, longitudinal observational study to map the trajectories of treatment response and disease progression. In this study, we will explore measurements of psoriatic disease activity at least an order of magnitude more frequently (weekly vs. quarterly) than standard clinical practice or clinical trial designs. This study is not meant to provide a medical diagnosis, treatment, or medical advice. It is meant to provide a scalable, inexpensive, non-invasive and frequent measure and tracking of psoriasis and psoriatic arthritis for research purposes.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Adult age 18 and older who consent to participate in the study
  • Own a compatible iPhone or iPod Touch device running iOS 12.2 or above
  • Be able to read and understand an official language of the country of participation

排除标准

  • Age 17 years or younger
  • Not a resident of the a country where the app is approved for use
  • Not have a personal (i.e., not shared) iPhone (4s or newer running iOS 8.0 or later)
  • Not be able to read and understand an official language of the country of participation

结局指标

主要结局

Results of participant self-assessment surveys

时间窗: Through study completion, an average of 2 years

Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.

Computer vision features from Finger/Toe Photos

时间窗: Through study completion, an average of 2 years

The investigators apply visual processing and classifier algorithms to segment nails and joints from hand and foot photos. These results may also be compared with other intervention results.

Computer vision features from Psoriasis Area Photo assessment

时间窗: Through study completion, an average of 2 years

The investigators apply visual processing and classifier algorithms to analyze the images from the Psoriasis Area Photo assessments. These results may also be compared with other intervention results.

Gyroscope and accelerometer sensor measurements from Digital Jar Open assessment

时间窗: Through study completion, an average of 2 years

The investigators examine rotational features from gyroscope and accelerometer sensors. The investigators apply feature selection and classifier algorithms to analyze these data. These results may also be compared with other intervention results.

Quantification and distribution of self-reported painful joints

时间窗: Through study completion, an average of 2 years

The investigators will quantify the self-reported painful joints and, in particular, compare to measurements from the 30-sec Walk and Digital Jar Open to identify correlations. These results may also be compared with other intervention results.

Body surface area and location from the Psoriasis Draw assessment

时间窗: Through study completion, an average of 2 years

The investigators will quantify body surface area and psoriasis area hotspots across the cohort. These results may also be compared with other intervention results.

Gyroscope and accelerometer sensor measurements from 30-sec Walk assessment

时间窗: Through study completion, an average of 2 years

The investigators examine step-dependent and sequence-dependent features from gyroscope and accelerometer sensors. The investigators apply feature selection and classifier algorithms to analyze these data. These results may also be compared with other intervention results.

次要结局

  • App usage data for assessment of participant engagement(Through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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