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Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:
NA trial testing Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis in Rheumatoid Arthritis in 101 participants. Completed in 6 November 2024.
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | screening |
| Enrollment | 101 |
| Start date | 27 January 2021 |
| Primary completion | 6 November 2024 |
| Estimated completion | 6 November 2024 |
| Sites | 1 location across United States |
Weill Medical College of Cornell University
Adults 40 to 75, any sex, with Rheumatoid Arthritis or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Self-reported
| Group | Value | 95% CI |
|---|---|---|
| Peer Coach Guided Online Learning Program | 28 | |
| Self-administered Online Learning Program (Control) | 16 |
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'
| Group | Value | 95% CI |
|---|---|---|
| Peer Coach Guided Online Learning Program | 1 | -1 – 4 |
| Self-administered Online Learning Program (Control) | 1 | 0 – 5 |
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 -
| Group | Value | 95% CI |
|---|---|---|
| Peer Coach Guided Online Learning Program | 1 | -2 – 4 |
| Self-administered Online Learning Program (Control) | 1 | -1 – 6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Peer Coach Guided Online Learning Program | 0.00 | -0.53 – 0.83 |
| Self-administered Online Learning Program (Control) | -0.10 | -0.47 – 0.50 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Peer Coach Guided Online Learning Program | -1 | -3 – 1 |
| Self-administered Online Learning Program (Control) | 0 | -3 – 1 |
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 s
| Group | Value | 95% CI |
|---|---|---|
| Peer Coach Guided Online Learning Program | 1 | -4 – 9 |
| Self-administered Online Learning Program (Control) | 2 | -4 – 9 |
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 participa
| Group | Value | 95% CI |
|---|---|---|
| Peer Coach Guided Online Learning Program | 0 | -1 – 1 |
| Self-administered Online Learning Program (Control) | 0 | 0 – 2 |
Time frame: From enrollment up to approximately 17 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Peer Coach Guided Online L… | Self-administered Online L… |
|---|---|---|---|
| Inappropriate Behavior Towards Coach | Social circumstances | — | — |
| Alarmingly High PHQ-8 Score | Social circumstances | — | — |
Data from ClinicalTrials.gov NCT04488497 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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