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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Behavioral: Telemedicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm, multisite pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Telemedicine Arm<br>Single Arm Intervention | Behavioral: Telemedicine<br>* 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).<br>|

What is the study measuring?
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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 |