Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA) (PsOWell)

Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA): Implementation of PsOWellTM in PsA

This will be a single-arm interventional study to test the acceptability, feasibility, and effectiveness of structured telemedicine visits to encourage lifestyle changes that will improve quality of life, disease impact, and disease activity in patients with psoriatic arthritis (PsA).

Study Overview

• Status: Recruiting
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Behavioral: Telemedicine

Detailed Description

The proposed trial will be embedded within clinical care. This is a 2-year interventional trial that will enroll patients with active psoriatic arthritis despite stable therapy among three centers (the University of Pennsylvania, University of Utah, and University of Oxford). The intervention employs PsOWellTM, a program that trains clinicians to utilize motivational interviewing to help patients set goals and make lifestyle/behavior changes for holistic management of psoriasis.

• Study Type: Interventional
• Enrollment (Estimated): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Hopkins Gillespie; Phone Number: (215) 614-1840; Email: Sarah.Hopkins@Pennmedicine.upenn.edu
• Study Contact Backup: Name: Study Coordinator; Email: SpAProgram@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Sarah Gillespie; Email: Sarah.Hopkins@Pennmedicine.upenn.edu
      • Principal Investigator: Alexis Ogdie-Beatty, MD
      • Contact: Coordinator; Email: SpAProgram@pennmedicine.upenn.edu
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Julieanne Hall; Email: Julieanne.Hall@hsc.utah.edu
      • Principal Investigator: Jessica Walsh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Population: Patients with Psoriatic Arthritis

  • Age 18-89.
  • Active symptoms of PsA as defined by a PsA Impact of Disease (PsAID) questionnaire score >4 (range 0-10, 4 is the patient acceptable symptom state) or a patient global assessment of greater than 4 (scale 0-10).
  • Patients should be stable on therapy (i.e., not planning to switch therapy at the current visit).
  • Meet CASPAR criteria.
  • Provision of signed and dated informed consent form.
  • Willingness to comply with all study procedures and availability for duration of the study.
  • Has access to a mobile phone or other mobile device.

Exclusion Criteria:

• Inability to provide informed consent.
• Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks.
• PsAID score ≤4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Telemedicine Arm; Single Arm Intervention	Behavioral: Telemedicine; The intervention will consist of two structured telemedicine visits delivered between two routine office visits and conducted by providers (nurse practitioners and clinical nurse specialists).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Patient satisfaction as assessed by Acceptability of Intervention Measure (AIM). The range of this measure is 4-20 where higher scores indicate greater acceptability and satisfaction	4 Months
Effectiveness	Effectiveness as measured by the Psoriatic Arthritis Impact of Disease 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status.	4 Months
Minimal Disease Activity	Minimal Disease Activity (MDA) Composite Score. MDA measures the state of the patient's disease activity. Achievement of MDA means attaining 5/7 of the following: Swollen Joint Count (SJC) ≤1, Tender Joint Count (TJC) ≤1, Enthesitis ≤1, Psoriasis Body Surface Area (BSA) ≤3%, Patient Global Assessment ≤ 20 (0-100), Patient Pain ≤ 20 (0-100), and Health Assessment Questionnaire (HAQ) <0.05 (0-3). It is a patient-reported and physician-assessed outcome.	4 Months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Alexis Ogdie-Beatty, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: 851058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Fully de-identified datasets will be shared with requesting parties after manuscript publication and following submission of a protocol by the requesting party and approval by the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No