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NCT Number: NCT05631223

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

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Acceptability

    Time frame: 4 Months

    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

  2. Effectiveness

    Time frame: 4 Months

    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.

  3. Minimal Disease Activity

    Time frame: 4 Months

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: PsOWell

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 30, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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