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

Part of paid clinical trials in Potsdam, New York.

Sponsor
St. Lawrence Health System
Study ID
NCT07034196
Status
Recruiting
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Conditions

  • Rheumatoid Arthritis (RA

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Primary Care Treatment in lieu of Rheumatologist — OTHER
    RA patients will be randomized to receive their RA care via their established PCP who completed a structured training course in RA and who has monthly case review/consultation sessions with the rheumatology team in this study

Study Details

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.

Key Dates

Start date
Jun 26, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Arm- Rheumatology Clinician
    Continue with usual RA care in their rheumatologist's office
  • Active Comparator: Intervention Arm- Primary Care Clinician
    RA patients will be randomized to receive their RA care via their established PCP who completed a structured training course in RA and who has monthly case review/consultation sessions with the rheumatology team in this study

Primary Outcome Measure

Change in Disease Activity Score (DAS-28) [ Time Frame: 6 and 12 month intervals relative to baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Lawrence HealthPotsdamNew York13676
McKailey Lyndaker
[email protected]
315-261-6352
Eyal Kedar, MD (SUB_INVESTIGATOR)

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St. Lawrence Health· Potsdam, NY

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