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

Primary Purpose

Psoriatic Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Telemedicine Arm

Arm Description

Single Arm Intervention

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2022
Last Updated
March 14, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05631223
Brief Title
Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA)
Acronym
PsOWell
Official Title
Use of Telemedicine to Address 'Off Target' Symptoms in Psoriatic Arthritis (PsA): Implementation of PsOWellTM in PsA
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This 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.
Allocation
N/A
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Telemedicine Arm
Arm Type
Experimental
Arm Description
Single Arm Intervention
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine
Intervention Description
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 Outcome Measure Information:
Title
Acceptability
Description
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
Time Frame
4 Months
Title
Effectiveness
Description
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.
Time Frame
4 Months
Title
Minimal Disease Activity
Description
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.
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Hopkins Gillespie
Phone
(215) 614-1840
Email
Sarah.Hopkins@Pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Email
SpAProgram@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Gillespie
Email
Sarah.Hopkins@Pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Coordinator
Email
SpAProgram@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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