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

Sponsor

University of Pennsylvania (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05631223

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Behavioral: Telemedicine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

87 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a single-arm, multisite pilot studyThis is a single-arm, multisite pilot study

Masking:

None (Open Label)

Masking Description:

As a pilot study to understand implementation barriers, assess feasibility, and effectiveness, this study is not blinded or randomized.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Acceptability [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
Effectiveness [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.
Minimal Disease Activity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05631223

Other Study ID Numbers:

851058

First Posted:

Nov 30, 2022

Last Update Posted:

Dec 9, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Psoriatic

Study Results

No Results Posted as of Dec 9, 2022