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| ID | Type | Description | Link |
|---|---|---|---|
| K23AR068449 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer coach guided online learning program | Experimental |
| |
| Self-administered online learning program | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months post-intervention, approximately 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Iris Navarro-Milan, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35428359 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization/Baseline Assessment |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2024 |
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| Standard of care | Behavioral | 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. |
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| 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. | 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. | 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. | 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. | 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. | Baseline and 3-months post-intervention, approximately 20 weeks |
| FG001 | 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. |
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| NOT COMPLETED |
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| Intervention |
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| 1-Week Post-Intervention Data Collection |
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| 3-Months Post-Intervention |
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Subjects who were enrolled and randomized but did not complete baseline were excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Routine Assessment of Patient Index Data 3 (RAPID3) | RAPID3 is a questionnaire focusing on physical function, pain, and patient global assessment of disease activity. The score helps rheumatologists understand the impact of RA on daily life and can guide treatment decisions. A conversion table is used to simplify patient's weighed RAPID3 score. A score between 0 to 1.0 is defined as near remission (NR), 1.3 - 2 as low severity (LS), 2.3 - 4 as moderate severity (MS), and 4.3 - 10 as high severity (HS). | Mean | Standard Deviation | Units on a Scale |
| ||||||||||||||
| MOS Social Support Survey | Medical Outcomes Study (MOS) Social Support Survey consists of 19 questions that are averaged to compute a single score ranging from 1-5. The raw score is then transformed so that the final score ranges from minimum of 0 to maximum of 100 through the formula: 100 X [(observed score - minimum possible score)/(maximum possible score - minimum possible score)]. A higher score indicates more support. A score of 70 or higher indicates high support. | Mean | Standard Deviation | Units on a Scale |
| ||||||||||||||
| Patient Activation Measure (PAM-13) | Survey assesses patients' individual competencies for self-management. The mean score of the 13 items is calculated and transformed into a standardized activation score ranging from 0-100 based on a conversion table provided by the developers for data collected before 2014. The resulting 0-100 score is then used to categorize the individual into one of four levels of patient activation. The closer the score is to 100 the more activated a patient is. | Mean | Standard Deviation | Units on a Scale |
| ||||||||||||||
| PHQ-8 Patient Depression Questionnare | Depression measure for population based studies. Each question is on a scale from 0-3. Score is the sum of the 8 items. Lowest possible score is a 0 and the highest possible score is 24. A score of 10 or greater is considered major depression and 20 or more is severe major depression. | Mean | Standard Deviation | Units on a Scale |
| ||||||||||||||
| General Self-Efficacy Scale | A 10-item questionnaire designed to assess a person's optimistic self-belief in their ability to cope with a variety of difficult demands and stressful life events. The total score ranges from 10 to 40, with higher scores indicating higher self-efficacy. Scores above 30 indicate high generalized self-efficacy. | Mean | Standard Deviation | Units on a Scale |
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| Medication Understanding and Use Self-Efficacy Scale (MUSE) | Survey measures self-efficacy of understanding and using prescription medication. Higher scores indicate a greater level of understanding and self-efficacy. Overall Muse scores range from 8-32. The average overall MUSE score is 30, so individuals scoring above 30 are categorized as having high medication understanding and use self-efficacy. | Mean | Standard Deviation | Units on a Scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | This analysis only includes individuals who had follow-up data. | Posted | Count of Participants | Participants | 3 months post-intervention, approximately 20 weeks |
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| 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. | This analysis only includes individuals who had follow-up data. | Posted | Median | Inter-Quartile Range | Units on a Scale | Baseline and 3-months post-intervention, approximately 20 weeks |
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| 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. | Participants who did not complete 3-months survey were excluded from analysis. | Posted | Median | Inter-Quartile Range | Units on a Scale | Baseline and 3-months post-intervention, approximately 20 weeks |
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| 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. | This analysis only includes individuals who had follow-up data. | Posted | Median | Inter-Quartile Range | Units on a Scale | Baseline and 3-months post-intervention, approximately 20 weeks |
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| 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. | This analysis only includes individuals who had follow-up data. | Posted | Median | Inter-Quartile Range | Units on a Scale | Baseline and 3-months post-intervention, approximately 20 weeks |
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| 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. | This analysis only includes individuals who had follow-up data. | Posted | Median | Inter-Quartile Range | Units on a Scale | Baseline and 3-months post-intervention, approximately 20 weeks |
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| 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. | This analysis only includes individuals who had follow-up data. | Posted | Median | Inter-Quartile Range | Units on a Scale | Baseline and 3-months post-intervention, approximately 20 weeks |
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From enrollment up to approximately 17 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 49 | 0 | 49 | 1 | 49 |
| EG001 | 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. | 0 | 52 | 0 | 52 | 1 | 52 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inappropriate Behavior Towards Coach | Social circumstances | Non-systematic Assessment | Participant had to be removed for aggressive behavior toward peer coach |
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| Alarmingly High PHQ-8 Score | Social circumstances | Non-systematic Assessment | Participant's PHQ fell into severely depressed category that physician though it best to remove them from the program |
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Because of our sample size, there is not a large enough power to make calculations that are statistically significant. Recruitment originally proved difficult because of the eligibility criteria requiring participants to not have had or discussed a cholesterol test due to participant's ambivalence on their certainty of having had one. This criterion was later removed two years into the study to ease recruitment. Intervention being anchored around physician's appointment also limited eligibility.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Iris Navarro Millan | Weill Cornell Medicine | 646-962-7875 | vam4007@med.cornell.edu |
| Aug 5, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D002318 | Cardiovascular Diseases |
| D006949 | Hyperlipidemias |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Lost to Follow-up |
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| Male |
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| Hispanic/Latinx |
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| Black or African American |
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| Asian/Pacific Islander |
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| Native American or Alaskan Native |
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| Other |
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| Multiple Race/Ethnicity Selected |
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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. |
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| OG001 | 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. |
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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.
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| OG001 |
| 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. |
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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. |
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