Trial Outcomes & Findings for Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis: (NCT NCT04488497)

NCT ID: NCT04488497

Last Updated: 2025-10-24

Results Overview

Self-reported

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: 3 months post-intervention, approximately 20 weeks
• Results posted on: 2025-10-24

Participant Flow

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.

Participant milestones

Measure	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.	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.
Randomization/Baseline Assessment STARTED	49	52
Randomization/Baseline Assessment COMPLETED	47	49
Randomization/Baseline Assessment NOT COMPLETED	2	3
Intervention STARTED	47	49
Intervention COMPLETED	38	42
Intervention NOT COMPLETED	9	7
1-Week Post-Intervention Data Collection STARTED	38	42
1-Week Post-Intervention Data Collection COMPLETED	38	40
1-Week Post-Intervention Data Collection NOT COMPLETED	0	2
3-Months Post-Intervention STARTED	38	40
3-Months Post-Intervention COMPLETED	38	38
3-Months Post-Intervention NOT COMPLETED	0	2

Reasons for withdrawal

Measure	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.	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.
Randomization/Baseline Assessment Lost to Follow-up	2	3
Intervention Physician Decision	2	1
Intervention Withdrawal by Subject	5	6
Intervention Lost to Follow-up	2	0
1-Week Post-Intervention Data Collection Lost to Follow-up	0	2
3-Months Post-Intervention Lost to Follow-up	0	2

Baseline Characteristics

Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:

Baseline characteristics by cohort

Measure	Peer Coach Guided Online Learning Program n=47 Participants 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.	Self-administered Online Learning Program (Control) n=49 Participants 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	Total n=96 Participants Total of all reporting groups
Age, Continuous	58.11 Years STANDARD_DEVIATION 7.22 • n=5 Participants	57.18 Years STANDARD_DEVIATION 8.24 • n=7 Participants	57.64 Years STANDARD_DEVIATION 7.73 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	30 Participants n=5 Participants	36 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latinx	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian/Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native American or Alaskan Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Multiple Race/Ethnicity Selected	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Routine Assessment of Patient Index Data 3 (RAPID3)	7.72 Units on a Scale STANDARD_DEVIATION 6.62 • n=5 Participants	7.14 Units on a Scale STANDARD_DEVIATION 5.55 • n=7 Participants	7.43 Units on a Scale STANDARD_DEVIATION 6.07 • n=5 Participants
MOS Social Support Survey	65.12 Units on a Scale STANDARD_DEVIATION 23.69 • n=5 Participants	63.93 Units on a Scale STANDARD_DEVIATION 23.33 • n=7 Participants	64.52 Units on a Scale STANDARD_DEVIATION 23.39 • n=5 Participants
Patient Activation Measure (PAM-13)	43.26 Units on a Scale STANDARD_DEVIATION 5.39 • n=5 Participants	43.60 Units on a Scale STANDARD_DEVIATION 6.40 • n=7 Participants	43.43 Units on a Scale STANDARD_DEVIATION 5.89 • n=5 Participants
PHQ-8 Patient Depression Questionnare	6.51 Units on a Scale STANDARD_DEVIATION 4.87 • n=5 Participants	7.29 Units on a Scale STANDARD_DEVIATION 5.59 • n=7 Participants	6.91 Units on a Scale STANDARD_DEVIATION 5.23 • n=5 Participants
General Self-Efficacy Scale	31 Units on a Scale STANDARD_DEVIATION 5.20 • n=5 Participants	30.42 Units on a Scale STANDARD_DEVIATION 5.37 • n=7 Participants	30.71 Units on a Scale STANDARD_DEVIATION 5.27 • n=5 Participants
Medication Understanding and Use Self-Efficacy Scale (MUSE)	28.64 Units on a Scale STANDARD_DEVIATION 5.39 • n=5 Participants	27.88 Units on a Scale STANDARD_DEVIATION 4.84 • n=7 Participants	28.25 Units on a Scale STANDARD_DEVIATION 5.11 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-intervention, approximately 20 weeks

Population: This analysis only includes individuals who had follow-up data.

Self-reported

Outcome measures

Measure	Peer Coach Guided Online Learning Program n=38 Participants 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.	Self-administered Online Learning Program (Control) n=38 Participants 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.
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	16 Participants

SECONDARY outcome

Timeframe: Baseline and 3-months post-intervention, approximately 20 weeks

Population: This analysis only includes individuals who had follow-up data.

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.

Outcome measures

Measure	Peer Coach Guided Online Learning Program n=38 Participants 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.	Self-administered Online Learning Program (Control) n=38 Participants 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.
Change in General Self-Efficacy (GSF) Score From Baseline to the End of the Study Between Arms.	1 Units on a Scale Interval -1.0 to 4.0	1 Units on a Scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Baseline and 3-months post-intervention, approximately 20 weeks

Population: Participants who did not complete 3-months survey were excluded from analysis.

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.

Outcome measures

Measure	Peer Coach Guided Online Learning Program n=38 Participants 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.	Self-administered Online Learning Program (Control) n=38 Participants 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.
Change in Patient Activation Measure (PAM) Score From Baseline to the End of the Study Between Arms.	1 Units on a Scale Interval -2.0 to 4.0	1 Units on a Scale Interval -1.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and 3-months post-intervention, approximately 20 weeks

Population: This analysis only includes individuals who had follow-up data.

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.

Outcome measures

Measure	Peer Coach Guided Online Learning Program n=38 Participants 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.	Self-administered Online Learning Program (Control) n=38 Participants 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.
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 Interval -0.53 to 0.83	-0.10 Units on a Scale Interval -0.47 to 0.5

SECONDARY outcome

Timeframe: Baseline and 3-months post-intervention, approximately 20 weeks

Population: This analysis only includes individuals who had follow-up data.

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.

Outcome measures

Measure	Peer Coach Guided Online Learning Program n=38 Participants 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.	Self-administered Online Learning Program (Control) n=38 Participants 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.
Change in Patient Health Questionnaire - 8 (PHQ-8) Score From Baseline to the End of the Study Between Arms	-1 Units on a Scale Interval -3.0 to 1.0	0 Units on a Scale Interval -3.0 to 1.0

SECONDARY outcome

Timeframe: Baseline and 3-months post-intervention, approximately 20 weeks

Population: This analysis only includes individuals who had follow-up data.

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.

Outcome measures

Measure	Peer Coach Guided Online Learning Program n=38 Participants 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.	Self-administered Online Learning Program (Control) n=38 Participants 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.
Change in MOS Social Support Survey Score From Baseline to the End of the Study Between Arms.	1 Units on a Scale Interval -4.0 to 9.0	2 Units on a Scale Interval -4.0 to 9.0

SECONDARY outcome

Timeframe: Baseline and 3-months post-intervention, approximately 20 weeks

Population: This analysis only includes individuals who had follow-up data.

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.

Outcome measures

Measure	Peer Coach Guided Online Learning Program n=38 Participants 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.	Self-administered Online Learning Program (Control) n=38 Participants 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.
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 Interval -1.0 to 1.0	0 Units on a Scale Interval 0.0 to 2.0

Adverse Events

Peer Coach Guided Online Learning Program

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Self-administered Online Learning Program (Control)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Peer Coach Guided Online Learning Program n=49 participants at risk 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.	Self-administered Online Learning Program (Control) n=52 participants at risk 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.
Social circumstances Inappropriate Behavior Towards Coach	2.0% 1/49 • Number of events 1 • From enrollment up to approximately 17 weeks	0.00% 0/52 • From enrollment up to approximately 17 weeks
Social circumstances Alarmingly High PHQ-8 Score	0.00% 0/49 • From enrollment up to approximately 17 weeks	1.9% 1/52 • Number of events 1 • From enrollment up to approximately 17 weeks

Additional Information

Dr. Iris Navarro Millan

Weill Cornell Medicine

Phone: 646-962-7875

Email: vam4007@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place