Psorcast Mobile Study

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621369
• Other study ID #: 202110921
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 31, 2027

Study information

• Verified date: July 2023
• Source: Sage Bionetworks
• Contact: Solveig K Sieberts, Ph.D
• Phone: 206-928-8266
• Email: psorcast[@]sagebase.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthralgia
• Arthritis
• Arthritis, Psoriatic
• Collagen Diseases
• Dermatologic Disease
• Joint Pain
• Plaque Psoriasis
• Psoriasis
• Psoriatic Arthritis
• Psoriatic Nail
• Rheumatic Diseases
• Rheumatologic Disease
• Skin Diseases

Intervention

Behavioral:
• Participant self-assessment surveys
At enrollment, participants are asked to complete a baseline health history, family history, and a participant-reported symptom inventory.
• Psoriasis Draw
Participants are asked to draw the location and size of psoriasis they currently experience. Participants are provided a body template onto which they can draw on their screen. Investigators estimate the percentage of body area affected.
• Psoriasis Area Photo
Participants are asked to take a picture of a representative psoriasis plaque and indicate the location of the plaque. They are asked to take a picture of the same area over time. The investigators are developing computer vision algorithms to assess the plaque.
• Finger and Toe Photos
Participants are asked to take pictures of the back of each hand and the top of each foot. These photos can be used to assess finger and toe swelling as well as psoriatic nail involvement. The investigators are developing computer vision algorithms to assess psoriatic nail involvement and digit swelling.
• Digital Jar Open
Participants are asked to internally and externally rotate the phone as it rests on a flat surface. Participants perform each direction (internal and external) and each arm (left and right) in turn. Gyroscope sensors measure the degree of rotation.
• 30 Second Walk
Participants are asked to walk in a straight line for 30 seconds. Gait is measured by gyroscope and accelerometer sensors. The investigators examine step-dependent and sequence-dependent features from these sensors. The investigators apply feature selection and classifier algorithms to analyze these data.

Other:
• Psorcast mobile application
Participants complete all described behavioral interventions via a dedicated iPhone app, Psorcast.

Locations

Country	Name	City	State
United States	Sage Bionetworks	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Sage Bionetworks	Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM), New York University, NYU Langone Health, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

DE Webster, RH Haberman, LM Perez Chada, M Tummalacherla, A Tediarjo, V Yadav, E Chaibub Neto, W MacDuffie, M DePhillips, E Sieg, S Catron, C Grant, W Francis, M Nguyen, M Yussuff, RL Castillo, D Yan, AL Neimann, SM Reddy, A Ogdie, A Kolivras, MR Kellen, LM Mangravite, SK Sieberts, L Omberg, JF Merola, JU Scher medRxiv 2022.04.13.22273676; doi: https://doi.org/10.1101/2022.04.13.22273676

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of participant self-assessment surveys	Results of participant self-assessment surveys will be analyzed using descriptive statistics. These results may also be compared with other intervention results.	Through study completion, an average of 2 years
Primary	Body surface area and location from the Psoriasis Draw assessment	The investigators will quantify body surface area and psoriasis area hotspots across the cohort. These results may also be compared with other intervention results.	Through study completion, an average of 2 years
Primary	Computer vision features from Psoriasis Area Photo assessment	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.	Through study completion, an average of 2 years
Primary	Computer vision features from Finger/Toe Photos	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.	Through study completion, an average of 2 years
Primary	Gyroscope and accelerometer sensor measurements from Digital Jar Open assessment	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.	Through study completion, an average of 2 years
Primary	Gyroscope and accelerometer sensor measurements from 30-sec Walk assessment	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.	Through study completion, an average of 2 years
Primary	Quantification and distribution of self-reported painful joints	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.	Through study completion, an average of 2 years
Secondary	App usage data for assessment of participant engagement	App usage data is used to gauge participant engagement throughout the study period. These results may also be compared with other intervention results.	Through study completion, an average of 2 years

External Links

•   Psorcast Study Website
•   Study App (App Store)