Psorcast Mobile Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05621369
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sage Bionetworks
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Solveig Sieberts, Ph.DJose Scher, MDJoseph Merola, MD, MMSc
Principal Investigator Affiliation	Sage BionetworksNYU Langone Medical CenterBrigham and Women's Hospital & Harvard Medical School
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis, Psoriasis, Psoriatic Conditions, Dermatologic Disease, Rheumatologic Disease, Psoriatic Nail, Plaque Psoriasis, Joint Pain, Dactylitis
Study Website:	View Trial Website

Additional Details

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.#46; 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.

Arms & Interventions

Arms

: Participants with Psoriasis

People who report a diagnosis of Psoriasis. Participants are invited via the Psorcast mobile application to complete the following assessments: Participant self-assessment surveys, skin assessments (Psoriasis Area Draw and Psoriasis Area Photo) and musculoskeletal assessments (Finger/Toe Photos, Joint Count, Digital Jar Open, 30s Walk).

: Participants with Psoriatic Arthritis

People who report a diagnosis of Psoriatic Arthritis. Participants are invited via the Psorcast mobile application to complete the following assessments: Participant self-assessment surveys, skin assessments (Psoriasis Area Draw and Psoriasis Area Photo) and musculoskeletal assessments (Finger/Toe Photos, Joint Count, Digital Jar Open, 30s Walk).

: Participants without Psoriasis or Psoriatic Arthritis

People who report no prior diagnosis of Psoriasis or Psoriatic Arthritis. Participants are invited via the Psorcast mobile application to complete the following assessments: Participant self-assessment surveys, skin assessments (Psoriasis Area Draw and Psoriasis Area Photo) and musculoskeletal assessments (Finger/Toe Photos, Joint Count, Digital Jar Open, 30s Walk).

Interventions

Behavioral: - Participant self-assessment surveys

At enrollment, participants are asked to complete a baseline health history, family history, and a participant-reported symptom inventory.

Behavioral: - 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.

Behavioral: - 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.

Behavioral: - 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.

Behavioral: - 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.

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sage Bionetworks, Seattle, Washington

Status

Recruiting

Address

Sage Bionetworks

Seattle, Washington, 98109

Site Contact

Christine Suver, PhD

[email protected]

206-667-2128

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