Rheumatoid ArthritisCARE RANCT04488497
Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:
A study testing Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis in people with Rheumatoid Arthritis and Cardiovascular Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Cardiovascular Diseases, Hyperlipidemias
- What is being tested?
- Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to 6 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Coronary angioplasty
- History of heart failure
- History of heart attack or stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Being tested
- Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis, Standard of care
- Keywords
- Self-efficacy, Patient activation, Social Cognitive Theory, Peer coaches
- Medical subject headings
- Arthritis, Rheumatoid, Cardiovascular Diseases, Hyperlipidemias, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Risk Assessment for Patients with Rheumatoid ArthritisBehavioural
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.
Standard of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer coach guided online learning program | Experimental | Not described Receives: Behavioral: Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis |
| Self-administered online learning program | Active comparator | Not described Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline and 3-months post-intervention, approximately 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start27 Jan 2021
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Iris Navarro-Milan, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488497
- Sponsor's protocol ID
- 1703018030
- Other IDs
- K23AR068449
- Acronym
- CARE RA
- Status last verified
- Oct 2025
- First submitted
- 22 Jul 2020
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35428359
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Hyperlipidemia Management Among Patients With Rheumatoid Arthritis: A Patient-centered Intervention Development
- ClinicalTrials.gov ID
- NCT04488497
- Acronym / sponsor ID
- CARE RA / 1703018030
- Keywords
- Self-efficacy, Patient activation, Social Cognitive Theory, Peer coaches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Risk Assessment for Patients with Rheumatoid ArthritisThis 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. | Behavioural | Peer coach guided online learning program |
| Standard of careParticipants 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. | Behavioural | Self-administered online learning program |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35428359Weiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Navarro-Milan, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis in people with Rheumatoid Arthritis and Cardiovascular Diseases, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.