Cardiovascular Diseases, Hyperlipidemias, Rheumatoid Arthritis
Conditions
Keywords
Self-efficacy, Patient activation, Social Cognitive Theory, Peer coaches
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.
Interventions
BEHAVIORALCardiovascular 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.
BEHAVIORALStandard 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.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months post-intervention, approximately 20 weeks | Self-reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Activation Measure (PAM) Score From Baseline to the End of the Study Between Arms. | 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. |
| Change in Routine Assessment of Patient Index Data (RAPID3) Score From Baseline to the End of the Study Between Arms. | 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. |
| Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms. | 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. |
| Change in MOS Social Support Survey Score From Baseline to the End of the Study Between Arms. | 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. |
| Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) Score From Baseline to the End of the Study Between Arms. | 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. |
| Change in Patient Health Questionnaire - 8 (PHQ-8) Score From Baseline to the End of the Study Between Arms | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period was from January 2021 to October 2024. Recruitment was facilitated via registries provided by the partnering organizations ArthritisPower, BuildClinical, and the BendCare Patient Network. The EHR Data and Reporting system TRAC was used to generate patient lists of potentially eligible patients from partnering surgeons. The first participant was enrolled on January 27, 2021 and the last participant was enrolled on June 5th, 2024.
Participants by arm
| Arm | Count |
|---|---|
| Peer Coach Guided Online Learning Program The CARE RA intervention consists of 3 components: peer support, patient activation, and online education via the patient activation learning website (PALS). Over the course of 5 weeks before their upcoming physician's appointment, participants met with a peer coach (a person with RA who has been trained on delivering the content of the CARE RA intervention to another person with RA) for weekly 30-45 minute one-on-one telephonic sessions to reinforce key points in the CARE RA curriculum within the PALS. | 47 |
| Self-administered Online Learning Program (Control) The self-administered control arm consists of a tutorial on how to use the Patient Activated Learning System (PALS) followed by self-driven completion of the CARE RA curriculum within the PALS over the course of 5 weeks before their upcoming physician's appointment | 49 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-Week Post-Intervention Data Collection | Lost to Follow-up | 0 | 2 |
| 3-Months Post-Intervention | Lost to Follow-up | 0 | 2 |
| Intervention | Lost to Follow-up | 2 | 0 |
| Intervention | Physician Decision | 2 | 1 |
| Intervention | Withdrawal by Subject | 5 | 6 |
| Randomization/Baseline Assessment | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Total | Self-administered Online Learning Program (Control) | Peer Coach Guided Online Learning Program |
|---|---|---|---|
| Age, Continuous | 57.64 Years STANDARD_DEVIATION 7.73 | 57.18 Years STANDARD_DEVIATION 8.24 | 58.11 Years STANDARD_DEVIATION 7.22 |
| General Self-Efficacy Scale | 30.71 Units on a Scale STANDARD_DEVIATION 5.27 | 30.42 Units on a Scale STANDARD_DEVIATION 5.37 | 31 Units on a Scale STANDARD_DEVIATION 5.2 |
| Medication Understanding and Use Self-Efficacy Scale (MUSE) | 28.25 Units on a Scale STANDARD_DEVIATION 5.11 | 27.88 Units on a Scale STANDARD_DEVIATION 4.84 | 28.64 Units on a Scale STANDARD_DEVIATION 5.39 |
| MOS Social Support Survey | 64.52 Units on a Scale STANDARD_DEVIATION 23.39 | 63.93 Units on a Scale STANDARD_DEVIATION 23.33 | 65.12 Units on a Scale STANDARD_DEVIATION 23.69 |
| Patient Activation Measure (PAM-13) | 43.43 Units on a Scale STANDARD_DEVIATION 5.89 | 43.60 Units on a Scale STANDARD_DEVIATION 6.4 | 43.26 Units on a Scale STANDARD_DEVIATION 5.39 |
| PHQ-8 Patient Depression Questionnare | 6.91 Units on a Scale STANDARD_DEVIATION 5.23 | 7.29 Units on a Scale STANDARD_DEVIATION 5.59 | 6.51 Units on a Scale STANDARD_DEVIATION 4.87 |
| Race/Ethnicity, Customized Race/Ethnicity Asian/Pacific Islander | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 12 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/Latinx | 9 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multiple Race/Ethnicity Selected | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native American or Alaskan Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 66 Participants | 36 Participants | 30 Participants |
| Routine Assessment of Patient Index Data 3 (RAPID3) | 7.43 Units on a Scale STANDARD_DEVIATION 6.07 | 7.14 Units on a Scale STANDARD_DEVIATION 5.55 | 7.72 Units on a Scale STANDARD_DEVIATION 6.62 |
| Sex: Female, Male Female | 88 Participants | 46 Participants | 42 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 52 |
| other Total, other adverse events | 1 / 49 | 1 / 52 |
| serious Total, serious adverse events | 0 / 49 | 0 / 52 |
Outcome results
Primary
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
Time frame: 3 months post-intervention, approximately 20 weeks
Population: This analysis only includes individuals who had follow-up data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peer Coach Guided Online Learning Program | 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. | 28 Participants |
| Self-administered Online Learning Program (Control) | 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. | 16 Participants |
p-value: 0.005Chi-squared
Secondary
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.
Time frame: Baseline and 3-months post-intervention, approximately 20 weeks
Population: This analysis only includes individuals who had follow-up data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peer Coach Guided Online Learning Program | Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms. | 1 Units on a Scale |
| Self-administered Online Learning Program (Control) | Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms. | 1 Units on a Scale |
p-value: 0.6Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline and 3-months post-intervention, approximately 20 weeks
Population: This analysis only includes individuals who had follow-up data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peer Coach Guided Online Learning Program | Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) Score From Baseline to the End of the Study Between Arms. | 0 Units on a Scale |
| Self-administered Online Learning Program (Control) | Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) Score From Baseline to the End of the Study Between Arms. | 0 Units on a Scale |
p-value: 0.2Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline and 3-months post-intervention, approximately 20 weeks
Population: This analysis only includes individuals who had follow-up data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peer Coach Guided Online Learning Program | Change in MOS Social Support Survey Score From Baseline to the End of the Study Between Arms. | 1 Units on a Scale |
| Self-administered Online Learning Program (Control) | Change in MOS Social Support Survey Score From Baseline to the End of the Study Between Arms. | 2 Units on a Scale |
p-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline and 3-months post-intervention, approximately 20 weeks
Population: Participants who did not complete 3-months survey were excluded from analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peer Coach Guided Online Learning Program | Change in Patient Activation Measure (PAM) Score From Baseline to the End of the Study Between Arms. | 1 Units on a Scale |
| Self-administered Online Learning Program (Control) | Change in Patient Activation Measure (PAM) Score From Baseline to the End of the Study Between Arms. | 1 Units on a Scale |
p-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline and 3-months post-intervention, approximately 20 weeks
Population: This analysis only includes individuals who had follow-up data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peer Coach Guided Online Learning Program | Change in Patient Health Questionnaire - 8 (PHQ-8) Score From Baseline to the End of the Study Between Arms | -1 Units on a Scale |
| Self-administered Online Learning Program (Control) | Change in Patient Health Questionnaire - 8 (PHQ-8) Score From Baseline to the End of the Study Between Arms | 0 Units on a Scale |
p-value: 0.5Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline and 3-months post-intervention, approximately 20 weeks
Population: This analysis only includes individuals who had follow-up data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peer Coach Guided Online Learning Program | Change in Routine Assessment of Patient Index Data (RAPID3) Score From Baseline to the End of the Study Between Arms. | 0.00 Units on a Scale |
| Self-administered Online Learning Program (Control) | Change in Routine Assessment of Patient Index Data (RAPID3) Score From Baseline to the End of the Study Between Arms. | -0.10 Units on a Scale |
p-value: 0.6Wilcoxon (Mann-Whitney)