Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07034196

Comparative Effectiveness of Primary Care Providers Trained in Rheumatoid Arthritis Management Versus Rheumatologist Care: A Randomized Controlled Trial

Led by St. Lawrence Health System · Updated on 2025-06-24

100

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Rheumatoid arthritis (RA) is a complex autoimmune disease where the immune system attacks healthy joint tissue; causing pain, swelling, and stiffness of the joints. This disease effects lots of people in the US and can lead to major joint damage if not properly treated. In rural areas like northern NY, these are underserved areas for RA patients, thus many patients struggle to get the appropriate care. This model is testing whether primary care providers (PCP) can safely and effectively provide stable RA patients with the proper treatment rather than send them to a specialist. PCPs were trained through classes, case reviews, and a final exam. Patients will be randomly assigned to either see a trained PCP or their normal rheumatologist at the rheumatology clinic. This study will examine how patients are doing over a year using medical exams and patient feedback. If this model proves to be successful, it will make RA treatment easier and more affordable for patients.

CONDITIONS

Official Title

Comparative Effectiveness of Primary Care Providers Trained in Rheumatoid Arthritis Management Versus Rheumatologist Care: A Randomized Controlled Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the 2010 ACR/EULAR criteria for rheumatoid arthritis diagnosis
  • Have stable RA disease activity with RAPID-3 score no higher than 4 over past three months or no RA medication changes for at least six months
  • Live in the North Country region of New York (Jefferson, Lewis, St. Lawrence, Clinton, Essex, Franklin, or Hamilton counties)
  • Be established patients with the participating rheumatology clinic and a participating PCP, with at least one visit in the previous year
  • Willing to participate and provide informed consent
  • Females of childbearing potential must agree to use highly effective birth control throughout the study
Not Eligible

You will not qualify if you...

  • Changes in RA treatment within six months prior to screening
  • History of interstitial lung disease or rheumatoid vasculitis manifestations (including cutaneous vasculitis, vasculitic neuropathy, episcleritis, scleritis, or keratitis)
  • Cognitive impairment or inability to complete study assessments
  • Pregnancy, breastfeeding, or plans to become pregnant during the study
  • Inability to adhere to study protocol or follow-up requirements
  • Any other comorbid condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Lawrence Health

Potsdam, New York, United States, 13676

Actively Recruiting

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Research Team

M

McKailey Lyndaker

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Comparative Effectiveness of Primary Care Providers Trained in Rheumatoid Arthritis Management Versus Rheumatologist Care: A Randomized Controlled Trial | DecenTrialz