NCT05621369

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2022Jan 2027

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

5.1 years

First QC Date

November 10, 2022

Last Update Submit

June 6, 2025

Conditions

Psoriatic ArthritisPsoriasisPsoriatic ConditionsDermatologic DiseaseRheumatologic DiseasePsoriatic NailPlaque PsoriasisJoint PainDactylitis

Keywords

PsoriasisPsoriatic ArthritisPsoriatic DiseaseHealth app researchmHealth researchMobile health research

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • App usage data for assessment of participant engagement

    Through study completion, an average of 2 years

Study Arms (3)

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).

Behavioral: Participant self-assessment surveysBehavioral: Psoriasis DrawBehavioral: Psoriasis Area PhotoBehavioral: Finger and Toe PhotosBehavioral: Digital Jar OpenBehavioral: 30 Second WalkOther: Psorcast mobile application

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).

Behavioral: Participant self-assessment surveysBehavioral: Psoriasis DrawBehavioral: Psoriasis Area PhotoBehavioral: Finger and Toe PhotosBehavioral: Digital Jar OpenBehavioral: 30 Second WalkOther: Psorcast mobile application

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).

Behavioral: Participant self-assessment surveysBehavioral: Psoriasis DrawBehavioral: Psoriasis Area PhotoBehavioral: Finger and Toe PhotosBehavioral: Digital Jar OpenBehavioral: 30 Second WalkOther: Psorcast mobile application

Interventions

Participant self-assessment surveysBEHAVIORAL

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

Participants with PsoriasisParticipants with Psoriatic ArthritisParticipants without Psoriasis or Psoriatic Arthritis
Psoriasis DrawBEHAVIORAL

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.

Participants with PsoriasisParticipants with Psoriatic ArthritisParticipants without Psoriasis or Psoriatic Arthritis
Psoriasis Area PhotoBEHAVIORAL

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.

Participants with PsoriasisParticipants with Psoriatic ArthritisParticipants without Psoriasis or Psoriatic Arthritis
Finger and Toe PhotosBEHAVIORAL

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.

Participants with PsoriasisParticipants with Psoriatic ArthritisParticipants without Psoriasis or Psoriatic Arthritis
Digital Jar OpenBEHAVIORAL

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.

Participants with PsoriasisParticipants with Psoriatic ArthritisParticipants without Psoriasis or Psoriatic Arthritis
30 Second WalkBEHAVIORAL

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.

Participants with PsoriasisParticipants with Psoriatic ArthritisParticipants without Psoriasis or Psoriatic Arthritis
Psorcast mobile applicationOTHER

Participants complete all described behavioral interventions via a dedicated iPhone app, Psorcast.

Participants with PsoriasisParticipants with Psoriatic ArthritisParticipants without Psoriasis or Psoriatic Arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with a compatible iPhone or iPod Touch who consent to particpate

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sage Bionetworks

Seattle, Washington, 98109, United States

RECRUITING

Related 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, PsoriaticPsoriasisSkin DiseasesCollagen DiseasesArthralgia

Interventions

Walking

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSkin Diseases, PapulosquamousSkin and Connective Tissue DiseasesConnective Tissue DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Solveig Sieberts, Ph.D

    Sage Bionetworks

    PRINCIPAL INVESTIGATOR

  • Jose Scher, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

  • Joseph Merola, MD, MMSc

    Brigham and Women's Hospital & Harvard Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Solveig K Sieberts, Ph.D

CONTACT

206-928-8266psorcast@sagebase.org

Christine Suver, Ph.D

CONTACT

206-667-2128christine.suver@sagebase.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 18, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

We will share the de-identified data from participants who opt-in to data sharing during enrollment and consent.

Shared Documents
ANALYTIC CODE

Locations

US(1)