Clinical trial NCT05621369: Psorcast Mobile Study
Official title: Psorcast Study: A Smartphone-based Study of Psoriasis and Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriatic Arthritis
Psoriasis
Psoriatic Conditions
Dermatologic Disease
Rheumatologic Disease
Psoriatic Nail
Plaque Psoriasis
Joint Pain
Dactylitis
Keywords: Psoriasis
Psoriatic Arthritis
Psoriatic Disease
Health app research
mHealth research
Mobile health research
Lead sponsor: Sage Bionetworks
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: NYU Langone Health
name: University of Pennsylvania
name: Harvard Medical School (HMS and HSDM)
name: New York University
First posted: 2022-11-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a compatible iPhone or iPod Touch who consent to particpate

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Results of participant self-assessment surveys
timeFrame: Through study completion, an average of 2 years
measure: Body surface area and location from the Psoriasis Draw assessment
timeFrame: Through study completion, an average of 2 years
measure: Computer vision features from Psoriasis Area Photo assessment
timeFrame: Through study completion, an average of 2 years
measure: Computer vision features from Finger/Toe Photos
timeFrame: Through study completion, an average of 2 years
measure: Gyroscope and accelerometer sensor measurements from Digital Jar Open assessment
timeFrame: Through study completion, an average of 2 years
measure: Gyroscope and accelerometer sensor measurements from 30-sec Walk assessment
timeFrame: Through study completion, an average of 2 years
measure: Quantification and distribution of self-reported painful joints
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: App usage data for assessment of participant engagement
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Sage Bionetworks
state: Washington
Study officials:
affiliation: Sage Bionetworks
name: Solveig Sieberts, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Medical Center
name: Jose Scher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital & Harvard Medical School
name: Joseph Merola, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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