2015 American College of Rheumatology Workforce Study: Supply and Demand Projections of Adult Rheumatology Workforce, 2015-2030.
Daniel F Battafarano, Marcia Ditmyer, Marcy B Bolster...
https://pubmed.ncbi.nlm.nih.gov/29400009Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07034196
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Rheumatoid arthritis (RA) is a chronic autoimmune disease where the immune system attacks joint tissue, causing pain, swelling, and stiffness. This condition affects about 1.5 million people in the US and can lead to serious joint damage if untreated. Access to specialized rheumatology care is limited, especially in rural areas like northern New York, making it difficult for many patients to receive proper treatment. This trial evaluates whether trained primary care providers (PCPs) can manage stable RA patients as effectively as rheumatologists, potentially improving care access in underserved regions. In this randomized controlled trial, patients with stable RA will be assigned to either continue care with their usual rheumatologist or receive care from a PCP who has completed a structured RA training program. Nine PCPs underwent training including lectures, case studies, and exams, with ongoing monthly case reviews with rheumatology specialists. The study will enroll up to 100 participants and follow them for one year, comparing the two care models. The intervention group receives RA management from trained PCPs, while the control group continues usual care in a rheumatology clinic. Participants will attend visits at screening/baseline, 6 weeks, 12 weeks, 26 weeks, 40 weeks, and 52 weeks. Assessments include standard RA activity measures like MD_HAQ, joint counts, disease activity scores (DAS28, CDAI, SDAI), glucocorticoid exposure, patient-reported outcomes, and medical records review. The main outcome is change in DAS-28 at 6 and 12 months. This study will monitor patient status and safety throughout the year to evaluate if PCP-led care can maintain disease control and improve access for rural RA patients.
CONDITIONS
Brief 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
You may qualify if you...
- Fulfillment of the 2010 ACR/EULAR criteria for definite rheumatoid arthritis
- Stable disease activity with RAPID-3 score no higher than 4 over the past three months or no RA medication changes for at least six months
- Primary residence in the North Country region of New York (Jefferson, Lewis, St. Lawrence, Clinton, Essex, Franklin, and Hamilton counties)
- Established patient with the participating rheumatology clinic and a participating primary care provider
- Willingness to participate and provide informed consent
- Females of childbearing potential must agree to use highly effective birth control during the study
You will not qualify if you...
- Changes in rheumatoid arthritis treatment within six months prior to screening
- History of interstitial lung disease or any rheumatoid vasculitis manifestations
- 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 comorbid condition making participation unsuitable in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 52 weeks
Participants receive rheumatoid arthritis care either from their trained primary care provider or from a rheumatology clinic. Care includes monthly case review sessions with the rheumatology team and ad hoc consultations as needed.
Visits at baseline, 6 weeks, 12 weeks, 26 weeks, 40 weeks, and 52 weeks
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
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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