RECRUITING

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

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Conditions

Rheumatoid Arthritis (RA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-26
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07034196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Fulfillment of the 2010 ACR/EULAR classification criteria for rheumatoid arthritis Using these criteria, a classification as "definite RA" is based upon the presence of synovitis in at least one joint, the absence of an alternative diagnosis that better explains the synovitis, and the achievement of a total score of at least 6 (of a possible 10) from the individual scores in four domains.
  2. * Number and site of involved joints:
  3. * 2 to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point
  4. * 1 to 3 small joints (from among the MCP joints, PIP joints, second through fifth MTP joints, thumb IP joints, and wrists) = 2 points
  5. * 4 to 10 small joints = 3 points
  6. * Greater than 10 joints (including at least 1 small joint) = 5 points
  7. * Serological abnormality (RF or ACPA)
  8. * Low positive (above the upper limit of normal) = 2 points
  9. * High positive (greater than three times the upper limit of normal) = 3 points
  10. * Elevated acute phase response (ESR or CRP) above the upper limit of normal = 1 point
  11. * Symptom duration at least six weeks = 1 point
  12. * Stable disease activity, defined as a RAPID-3 score of no higher than 4 over the past three months or no RA-related medication changes for at least six months prior to the informed consent date.
  13. * Primary residence in the North Country region of New York (Jefferson, Lewis, St. Lawrence, Clinton, Essex, Franklin, and Hamilton counties).
  14. * Established with the participating rheumatology clinic and a participating PCP (Note: For patients who are established in PCP clinics outside of the health system conducting this study, patients may see a participating PCP within their established clinic). To be considered an established patient, the participant should have had a visit within the year prior to the screening visit.
  15. * Willingness to participate in the study and provide informed consent.
  16. * Females of childbearing potential must agree to use highly effective birth control throughout duration of the study.
  1. * Changes in RA treatment within the six months prior to screening.
  2. * History of interstitial lung disease or any manifestation of rheumatoid vasculitis including cutaneous rheumatoid vasculitis, vasculitic neuropathy, RA-associated episcleritis, scleritis or keratitis)
  3. * Cognitive impairment or inability to complete study assessments.
  4. * Pregnancy, breastfeeding, or plans to become pregnant during the study period.
  5. * Inability to adhere to the study protocol or follow-up requirements.
  6. * Any comorbid condition that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.

Contacts and Locations

Study Contact

McKailey Lyndaker
CONTACT
315-261-6352
mckailey.lyndaker@rochesterregional.org

Principal Investigator

Eyal Kedar, MD
PRINCIPAL_INVESTIGATOR
St. Lawrence Health

Study Locations (Sites)

St. Lawrence Health
Potsdam, New York, 13676
United States

Collaborators and Investigators

Sponsor: St. Lawrence Health System

  • Eyal Kedar, MD, PRINCIPAL_INVESTIGATOR, St. Lawrence Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-26
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-06-26
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis (RA