Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:

NCT04488497 | Completed Results

• 2 other identifiers: 1703018030K23AR068449
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Keywords

Self-efficacy; Patient activation; Social Cognitive Theory; Peer coaches

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Lipids Checked (Available Now Through National Laboratory Chain) or That Reported Having Their Lipids Checked by Their 1-week or 3-month Visit.

  Self-reported

  3 months post-intervention, approximately 20 weeks

Secondary Outcomes (6)

• Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms.

  Baseline and 3-months post-intervention, approximately 20 weeks

• Change in Patient Activation Measure (PAM) Score From Baseline to the End of the Study Between Arms.

  Baseline and 3-months post-intervention, approximately 20 weeks

• Change in Routine Assessment of Patient Index Data (RAPID3) Score From Baseline to the End of the Study Between Arms.

  Baseline and 3-months post-intervention, approximately 20 weeks

• Change in Patient Health Questionnaire - 8 (PHQ-8) Score From Baseline to the End of the Study Between Arms

  Baseline and 3-months post-intervention, approximately 20 weeks

• Change in MOS Social Support Survey Score From Baseline to the End of the Study Between Arms.

  Baseline and 3-months post-intervention, approximately 20 weeks

Study Arms (2)

Peer coach guided online learning program

EXPERIMENTAL

Behavioral: Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis

Self-administered online learning program

ACTIVE COMPARATOR

Behavioral: Standard of care

Interventions

Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis 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.

Peer coach guided online learning program

Standard of care 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.

Self-administered online learning program

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 35428359 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Cardiovascular Diseases; Hyperlipidemias; Patient Participation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Because of our sample size, there is not a large enough power to make calculations that are statistically significant. Recruitment originally proved difficult because of the eligibility criteria requiring participants to not have had or discussed a cholesterol test due to participant's ambivalence on their certainty of having had one. This criterion was later removed two years into the study to ease recruitment. Intervention being anchored around physician's appointment also limited eligibility.

Results Point of Contact

• Title: Dr. Iris Navarro Millan
• Organization: Weill Cornell Medicine

vam4007@med.cornell.edu

646-962-7875

Study Officials

• Iris Navarro-Milan, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: January 27, 2021
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)