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

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Completed

Conditions

Hyperlipidemias
Cardiovascular Diseases
Rheumatoid Arthritis

Treatments

Behavioral: Standard of care
Behavioral: Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04488497
1703018030
K23AR068449 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

79 participants in 2 patient groups, including a placebo group

Peer coach guided online learning program
Experimental group
Treatment:
Behavioral: Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis
Self-administered online learning program
Placebo Comparator group
Treatment:
Behavioral: Standard of care

Trial contacts and locations

1

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Central trial contact

Iris Navarro-Millan, MD

Data sourced from clinicaltrials.gov

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