PREVAIL Model of Care for Rheumatoid Arthritis

Overseen By Louise Thoma, PT, DPT, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Cognitive impairment, Terminal illness, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if integrating rehabilitation into regular care through the PREVAIL model can benefit people with rheumatoid arthritis (RA). The model uses a screening tool to guide exercise and rehab recommendations tailored for RA patients. Participants will receive advice from their rheumatology doctor based on screening results and may have a brief consultation with a physical therapist. This trial may suit adults diagnosed with RA who currently receive routine care from a rheumatology doctor at UNC. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could enhance RA management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on integrating rehabilitation and exercise into your care, so it's likely you can continue your medications, but you should confirm with the trial coordinators.

What prior data suggests that the PREVAIL model of care is safe for adults with rheumatoid arthritis?

Research shows that the PREVAIL model of care aims to integrate rehabilitation into regular rheumatology visits for people with rheumatoid arthritis (RA). Studies have examined how well this model can be part of normal care, rather than focusing on specific safety concerns. The goal is to use a screening tool to guide exercise and rehabilitation advice.

Since this trial does not test a new drug or involve invasive treatment, the safety risks remain very low. The model includes assessments and exercise recommendations, which are generally safe for most people. Exercise is known to help manage RA symptoms.

Although specific safety data is not available, it's important to note that this trial does not involve new medications or high-risk procedures. It focuses on improving current care practices. Therefore, it is expected to be well-tolerated, based on what is typical for similar care models. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PREVAIL model of care for rheumatoid arthritis because it introduces a personalized approach based on a patient's DAPS score. Unlike traditional treatments that primarily focus on medication, this model offers tailored exercise resources and may include a brief physical therapy consultation. This approach aims to empower patients with more personalized and proactive management strategies, potentially improving their quality of life and treatment outcomes.

What evidence suggests that the PREVAIL model of care is effective for rheumatoid arthritis?

Research has shown that the PREVAIL model of care could be a promising way to help people with rheumatoid arthritis (RA). In this trial, participants in the intervention group will receive recommendations from their rheumatology provider based on their DAPS score. This tool assesses patients' ability to perform daily activities, guiding doctors on whether patients need more exercise or therapy. The goal is to integrate therapy into regular RA care, potentially improving patients' function and quality of life. Early reports suggest that using DAPS might lead to better outcomes for RA patients compared to standard methods. Overall, it appears to be a useful way to manage RA symptoms with personalized exercise and therapy recommendations. ^{1 3 4 6 7}

Who Is on the Research Team?

Louise Thoma, DPT, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults with rheumatoid arthritis. Participants should be scheduled for a routine visit with their rheumatology clinician and willing to follow the PREVAIL model of care, which includes using an online exercise resource. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am over 18 years old.

I have been diagnosed with rheumatoid arthritis.

Receiving routine care from a UNC rheumatology clinician

Exclusion Criteria

I have significant memory or thinking problems.

Current or recent (within the last six months) participation in PT

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 months

EMR Review and Pre-Screening

Baseline Assessment

Participants complete baseline assessments including the DAPS tool before their routine visit with a rheumatology clinician

1 week

1 visit (in-person)

Routine Visit and Intervention

Participants attend a routine visit with a rheumatology clinician, receive exercise and/or rehabilitation recommendations, and may have a brief PT consultation call

1 day

1 visit (in-person)

Follow-up

Participants complete follow-up assessments to evaluate the feasibility and acceptability of the PREVAIL model of care

3 months

1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PREVAIL model of care

Trial Overview The PREVAIL model of care is being tested to see if it's a good way to add rehabilitation into regular treatment for rheumatoid arthritis patients. It involves screening with DAPS, advice on rehab and exercise from clinicians, and an online exercise program tailored for RA.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Participants will all receive a recommendation from their rheumatology provider based on their DAPS score. Recommendations will consist of an exercise resource and potentially a referral for a brief PT consultation call.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

A study of 5078 rheumatoid arthritis patients revealed that an innovative disease-management program significantly improved clinical outcomes compared to conventional care, with a notable increase in remission rates from 20.8% to 58.5%.

Patients in the innovative program also experienced a substantial reduction in high disease activity, decreasing from 18% to 4.7%, indicating that specialized care can lead to better management of rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Patients with Rheumatoid Arthritis Treated in a Disease Management Program: Real-World Results. Santos-Moreno, P., Castillo, P., Villareal, L., et al.[2022]

Citations

1. trials.arthritis.org trials.arthritis.org/trials/NCT06706999

Feasibility and Acceptability of PREVAIL (PREserving Valued ... The goal of this clinical trial is to learn if the PREVAIL model of care is a feasible way to integrate rehabilitation into routine rheumatology care for adults ...

2. reporter.nih.gov reporter.nih.gov/project-details/10874654

Helping Adults with RA PREVAIL: Developing a model ... The objective of this research proposal is to develop and pilot test a scalable model (PREVAIL) for integrating rehabilitation into routine care to preserve ...

3. trial.medpath.com trial.medpath.com/clinical-trial/7e4d380a84cdb8ba/nct06706999-pilot-study-prevail-feasibility

Feasibility and Acceptability of PREVAIL (PREserving Valued ... The DAPS screening tool in the PREVAIL model correlate with functional outcomes in rheumatoid arthritis patients compared to standard assessments.

4. apta.confex.com apta.confex.com/apta/csm2025/meetingapp.cgi/Paper/47453

Refining Prevail: A Model to Integrate Rehabilitation into ... The PREVAIL model of care proposes a function-focused screening survey at a routine rheumatology visit to guide rheumatology referrals to rehabilitation and ...

5. acrabstracts.org acrabstracts.org/abstract/development-of-the-prevail-model-of-care-optimizing-feasibility-and-acceptability-for-trial-implementation/

Development of the PREVAIL model of care: Optimizing ... The PREVAIL model of care uses a screening survey assessing disability and functional impairment at a routine rheumatology visit to guide the delivery of ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1386505625001327

Predicting rheumatoid arthritis in the middle-aged and ... Our study has demonstrated the feasibility of using machine learning models to predict RA based on patient-reported outcomes. Based on patient survey ...

7. mdpi.com mdpi.com/2073-4468/14/3/54

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 ...