N/A N=101 Randomized Single-blind Screening

Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:

Rheumatoid Arthritis · Cardiovascular Diseases · Hyperlipidemias

Bottom Line

View on ClinicalTrials.gov: NCT04488497 ↗

Enrolled (actual)

101

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcome: Primary: 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. — 28; 16 Participants — p=0.005

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis (Behavioral); Standard of care (Behavioral)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	28; 16	0.005 sig
SECONDARY Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms.	1; 1	0.60
SECONDARY Change in Patient Activation Measure (PAM) Score From Baseline to the End of the Study Between Arms.	1; 1	0.40
SECONDARY Change in Routine Assessment of Patient Index Data (RAPID3) Score From Baseline to the End of the Study Between Arms.	0.00; -0.10	0.60
SECONDARY Change in Patient Health Questionnaire - 8 (PHQ-8) Score From Baseline to the End of the Study Between Arms	-1; 0	0.50
SECONDARY Change in MOS Social Support Survey Score From Baseline to the End of the Study Between Arms.	1; 2	0.90
SECONDARY Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) Score From Baseline to the End of the Study Between Arms.	0; 0	0.20

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04488497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.