100 Participants Needed

Primary Care for Rheumatoid Arthritis

(TRAIN Trial)

ML
Overseen ByMcKailey Lyndaker
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: St. Lawrence Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether primary care doctors can effectively manage rheumatoid arthritis (RA) instead of specialists. RA is a disease where the immune system attacks joints, causing pain and swelling. Participants will either continue seeing their rheumatologist or switch to a trained primary care provider. The trial focuses on people with stable RA living in northern New York who haven't changed their RA treatment in the last six months. The goal is to determine if care from a primary care provider can be a safe and convenient option for patients. As an unphased trial, this study offers patients the opportunity to contribute to research that could make RA care more accessible and convenient.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that there have been no changes in your RA treatment for at least six months before joining the study.

What prior data suggests that this model is safe for RA patients?

Research has shown that treatments for rheumatoid arthritis (RA) in regular doctor's offices can be quite safe. Patients receiving standard RA treatments from their primary care doctor typically experience side effects similar to those seen when treated by specialists. For example, studies have found that some RA medications are well-tolerated, with side effects comparable to those of a placebo, which contains no active medicine. This study aims to determine if primary care doctors can safely manage RA treatment. In simple terms, the study examines whether visiting a regular doctor can be as safe and effective as seeing a specialist for RA care.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way of managing rheumatoid arthritis (RA) by integrating primary care clinicians into the treatment process. Unlike the traditional model where RA care primarily occurs in a rheumatologist's office, this approach involves primary care providers who have been specially trained in RA management and collaborate closely with a rheumatology team. This could make RA care more accessible and personalized, potentially improving patient outcomes by providing consistent, coordinated care from a familiar healthcare provider.

What evidence suggests that this model is effective for rheumatoid arthritis?

This trial will compare the effectiveness of primary care and specialized rheumatology care for rheumatoid arthritis (RA). Research has shown that primary care can effectively treat RA. Studies have found that targeting low disease activity or remission improves outcomes for RA patients. Additionally, combining primary care with specialized treatments can help reduce disease activity and joint pain. Evidence suggests that with proper training, primary care doctors can manage RA as effectively as specialists. Furthermore, nurse-led care has proven to be just as effective as rheumatologist-led care in managing RA. These findings support the idea that well-trained primary care providers can successfully treat RA.678910

Who Is on the Research Team?

EK

Eyal Kedar, MD

Principal Investigator

St. Lawrence Health

Are You a Good Fit for This Trial?

This trial is for individuals with stable Rheumatoid Arthritis, particularly those in rural areas like northern NY where access to specialists is limited. Participants will be randomly assigned to receive care from either a trained primary care provider or a rheumatologist.

Inclusion Criteria

Fulfillment of the 2010 ACR/EULAR classification criteria for rheumatoid arthritis
Primary residence in the North Country region of New York (Jefferson, Lewis, St. Lawrence, Clinton, Essex, Franklin, and Hamilton counties)
Established with the participating rheumatology clinic and a participating PCP
See 2 more

Exclusion Criteria

Pregnancy, breastfeeding, or plans to become pregnant during the study period
Inability to adhere to the study protocol or follow-up requirements
I have had interstitial lung disease or rheumatoid vasculitis.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Initial data collection at baseline using standard assessments of RA activity

1 week
1 visit (in-person)

Treatment

Participants receive RA management from either trained PCPs or rheumatologists, with monthly case review sessions

52 weeks
Monthly visits (in-person) and ad hoc consultations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Primary Care Treatment
Trial Overview The study aims to determine if primary care providers, after receiving specialized training, can manage Rheumatoid Arthritis as effectively as rheumatologists. It involves comparing patient outcomes over one year between the two groups using medical exams and patient feedback.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Control Arm- Rheumatology ClinicianActive Control1 Intervention
Group II: Intervention Arm- Primary Care ClinicianActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Lawrence Health System

Lead Sponsor

Citations

Evidence for treating rheumatoid arthritis to targetThe current study expands the evidence that targeting low-disease activity or remission in the management of RA conveys better outcomes than routine care.
Management of Rheumatoid Arthritis With a Digital Health ...These findings suggest that assessing patient-reported outcomes using a smartphone application resulted in clinical improvement in disease activity.
Integrating Primary Care and Specialized Therapies in ...Medical management of RA can aim at different outcomes, ranging from disease remission, reduction in disease activity, and the alleviation of joint pain and ...
Real‐World Treatment Effectiveness of Disease‐Modifying ...In this real-world cohort study, seropositive and seronegative patients with RA had similar 1-year treatment effectiveness after initiating a bDMARD/JAKi.
Effectiveness of nurse-led care in patients with rheumatoid ...NLC proves highly effective in managing RA patients, surpassing usual care and equating to rheumatologist-led care in primary and some secondary outcomes.
Safety outcomes in patients with rheumatoid arthritis ...Data from randomized, controlled clinical trials have shown abatacept to be well tolerated, with adverse event rates similar to those of placebo, and to have a ...
CorEvitas Rheumatoid Arthritis (RA) Drug Safety & ...This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for RA ...
Survival Outcomes and Prognostic Factors in Rheumatoid ...Results: Over a mean follow-up of 9.4 years, the mortality rate was 13.5 deaths per 1000 treatment-years, with an overall survival rate of 87.3%. Advanced ...
Comparison of the Efficacy and Safety of Disease‐Modifying ...The primary efficacy outcome was the 50% improvement rate according to the American College of Rheumatology criteria (ACR50), and the primary ...
Factors Associated With Quality Care Among Adults ...The findings of this study suggest that quality care for patients with rheumatoid arthritis can be improved by prioritizing early treatment and focusing on ...
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