Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:

NCT ID: NCT04488497

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2024-11-06

Brief Summary

One of the greatest success stories in rheumatology - the achievement of rheumatoid arthritis (RA) remission - is tempered by the fact that individuals with RA are dramatically under evaluated and under treated to reduce the risk for heart attacks and strokes. This project will build the foundation for an intervention that will test the hypothesis that the patient-centered intervention tailored to patients with RA to improve hyperlipidemia screening and treatment, thereby decreasing the risk for heart attacks and strokes.

The aims of this proposal are:

Aim 1: To identify patient and physician barriers to lower the risk for heart attacks and strokes in patients with RA.

Aim 2: To develop an intervention designed to optimize lipid screening and management in RA patients. This will consist of patient education and a decision support program to facilitate screening for hyperlipidemia (high cholesterol level) or initiation of medications to lower cholesterol (primary outcome) and self-efficacy (level of confidence in performing a task) in taking medications to lower cholesterol secondary outcome).

Aim 3: To pilot test the efficacy and feasibility of intervention developed in Aim 2. The investigators will apply methods related to clinical trials to test the feasibility of the newly developed intervention.

Conditions

Rheumatoid Arthritis; Cardiovascular Diseases; Hyperlipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Peer coach guided online learning program

Group Type: EXPERIMENTAL

Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis

Intervention Type: BEHAVIORAL

This intervention will help people with RA get tested for hyperlipidemia so that they can later discuss with their physician how to better treat their increased risk for cardiovascular disease.

Self-administered online learning program

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: BEHAVIORAL

Participants in this group will not receive peer coaches calls. They will receive additional educational materials about CVD risk and the regular care provided by their doctors.

Interventions

Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis

This intervention will help people with RA get tested for hyperlipidemia so that they can later discuss with their physician how to better treat their increased risk for cardiovascular disease.

Intervention Type: BEHAVIORAL

Standard of care

Participants in this group will not receive peer coaches calls. They will receive additional educational materials about CVD risk and the regular care provided by their doctors.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Have RA
• Age between 40 and 75 years (inclusive)
• Provide a date of their next appointment with their rheumatologist or other physician on their care team
• Willing to work with a peer coach
• Speaks English
• Have a phone
• Has access to the internet
• Resides or lives in the US

Exclusion Criteria

• Do not have rheumatoid arthritis
• Younger than age 40 or older than age 75
• Taking a statin
• No known history of diabetes
• No known history of CVD defined by:

• Open heart surgery
• Coronary angioplasty
• History of heart failure
• History of heart attack or stroke

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iris Navarro-Milan, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

References

Weiner J, Lui G, Brown M, Paez YD, Fritz S, Sydnor-Campbell T, Allen A Jr, Jabri A, Venkatachalam S, Gavigan K, Nowell WB, Curtis JR, Fraenkel L, Safford M, Navarro-Millan I. Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention. Pilot Feasibility Stud. 2022 Apr 15;8(1):84. doi: 10.1186/s40814-022-01041-z.

Reference Type: DERIVED

PMID: 35428359 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23AR068449

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1703018030

Identifier Type: -

Identifier Source: org_study_id