NCT05631223

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

November 18, 2022

Last Update Submit

February 12, 2026

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Interventional Telemedicine Arm

EXPERIMENTAL

Single Arm Intervention

Behavioral: Telemedicine

Interventions

TelemedicineBEHAVIORAL

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).

Interventional Telemedicine Arm

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to provide informed consent.
  • Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks.
  • PsAID score ≤4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Alexis Ogdie-Beatty, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
As a pilot study to understand implementation barriers, assess feasibility, and effectiveness, this study is not blinded or randomized.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm, multisite pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 30, 2022

Study Start

March 10, 2023

Primary Completion

February 6, 2026

Study Completion

February 6, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(2)