Clinical trial NCT04488497: Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:
Official title: Optimization of Hyperlipidemia Management Among Patients With Rheumatoid Arthritis: A Patient-centered Intervention Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Cardiovascular Diseases
Hyperlipidemias
Keywords: Self-efficacy
Patient activation
Social Cognitive Theory
Peer coaches
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-07-28
Enrollment: 79
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Number of subjects screened for hyperlipidemia
timeFrame: 3 months post-intervention
measure: Number of subjects who initiated a statin
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: General Self-Efficacy Scale (GSF) score
timeFrame: 3 months post-intervention
measure: Patient Activation Measure (PAM) score - 13 item
timeFrame: 3 months post-intervention
measure: Routine Assessment of Patient Index Data (RAPID3) score
timeFrame: 3 months post-intervention
measure: Patient Health Questionnaire - 8 (PHQ-8) score
timeFrame: 3 months post-intervention
measure: Social Support Survey score
timeFrame: 3 months post-intervention
measure: Medication Understanding and Use Self-Efficacy Scale (MUSE) score
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Iris Navarro-Milan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.