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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Telemedicine Arm | Experimental | Single Arm Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Behavioral | 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). |
| 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 |
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Inclusion Criteria:
Population: Patients with Psoriatic Arthritis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Ogdie-Beatty, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Utah |
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.
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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This is a single-arm, multisite pilot study
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As a pilot study to understand implementation barriers, assess feasibility, and effectiveness, this study is not blinded or randomized.
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| Salt Lake City |
| Utah |
| 84112 |
| United States |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |