Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis: (CARE RA)

October 9, 2025 updated by: Weill Medical College of Cornell University

Optimization of Hyperlipidemia Management Among Patients With Rheumatoid Arthritis: A Patient-centered Intervention Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer coach guided online learning program
Behavioral: 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.
Active Comparator: Self-administered online learning program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months post-intervention, approximately 20 weeks
Self-reported
3 months post-intervention, approximately 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms.
Time Frame: Baseline and 3-months post-intervention, approximately 20 weeks

The scale consists of 10 items and each item score ranges from 1 ("not at all true") to 4 ("exactly true"). Values 2 and 3 are assigned "barely true" and "moderately true", respectively. Scores are summed across the 10 items to give a total score, with a possible range of 10-40. Higher scores indicate greater confidence in generalized self-efficacy. Scores above 30 indicate high generalized self-efficacy, and scores 30 or below indicate low to moderate generalized self-efficacy.

To find the change in GSF score from baseline to the end of the study between arms, the median of each participant's change in score was calculated.
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.
Time Frame: Baseline and 3-months post-intervention, approximately 20 weeks

The scale consists of 13 items and each item score ranges from 0 ("not applicable") to 4 ("agree strongly"). Values 1, 2, and 3 are assigned "disagree strongly", "disagree", and "agree", respectively. Scores are summed across the 13 items to give a total score, with a range of 0-52. The mean score is then transformed into a standardized activation score ranging from 0-100, (the PAM score), based on a conversion table provided by the developer of the scale. Score ranges correspond to levels of activation, with higher levels indicating more activation: Level 1 - score of 47.0 or lower, Level 2 - score between 47.1 to 55.1, Level 3 - score between 55.2 to 72.4, Level 4 - score 72.5 or above.

To find the change in PAM score from baseline to the end of the study between arms, the median of each participant's change in score was calculated.
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.
Time Frame: Baseline and 3-months post-intervention, approximately 20 weeks

The scale consists of 12 score-able items. The scores from item 1 through 10, 11, and 12 are summed with a range of 0-30 and this is the RAPID3 cumulative score. A final conversion table is used to simplify the score. A score between 0-1.0 is defined as near remission (NR); 1.3-2.0 is low severity (LS); 2.3-4.0 is moderate severity (MS); and 4.3-10.0 is high severity (HS).

To find the change in RAPID3 score from baseline to the end of the study between arms, the median of each participant's change in score was calculated.
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
Time Frame: Baseline and 3-months post-intervention, approximately 20 weeks

The scale consists of 8 items, and each item score ranges from 0 ("not at all") to 3 ("nearly every day"). Scores are summed across the 8 items. The lowest possible score is 0 and the highest possible is 24. A score of 10 or greater is considered major depression and 20 or more is severe major depression.

To find the change in PHQ-8 score from baseline to the end of the study between arms, the median of each participant's change in score was calculated.
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.
Time Frame: Baseline and 3-months post-intervention, approximately 20 weeks

The survey consists of 4 separate social support sub-scales and an overall functional social support index for a total of 19 items. To obtain an overall support index score, the average is calculated for both the first 18 items in the scale and the last item in the scale from a range of 1-5. Scale scores are transformed to a 0-100 scale using a formula. A higher score indicates more support. The average score for the overall support index is 70, so individuals scoring above 70 are categorized as having high support and individuals scoring 70 or lower are categorized as having low to moderate support.

To find the change in social support survey score from baseline to the end of the study between arms, the median of each participant's change in score was calculated.
Baseline and 3-months post-intervention, approximately 20 weeks
Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) Score From Baseline to the End of the Study Between Arms.
Time Frame: Baseline and 3-months post-intervention, approximately 20 weeks

The scale consists of 8 items. Possible scores for overall MUSE range from 8-32. A higher overall MUSE score indicates a higher level of self-efficacy in understanding and using prescription medications. The average overall MUSE score is 30, so individuals scoring above 30 are categorized as having high medication understanding and use self-efficacy and individuals scoring 30 or lower are categorized as having low to moderate medication understanding and use self-efficacy.

To find the change in MUSE scale scoring from baseline to the end of the study between arms, the median of each participant's change in score was calculated.
Baseline and 3-months post-intervention, approximately 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

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

Investigators

  • Principal Investigator: Iris Navarro-Milan, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Actual)

November 6, 2024

Study Completion (Actual)

November 6, 2024

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 9, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1703018030
  • K23AR068449 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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