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

Psoriatic Arthritis Clinical Trial

— PsOWell  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631223
• Other study ID #: 851058
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Sarah Hopkins Gillespie
• Phone: (215) 614-1840
• Email: Sarah.Hopkins[@]Pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

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).

Locations

Country	Name	City	State
United States	University Of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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