Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis: (CARE RA)
Primary Purpose
Rheumatoid Arthritis, Cardiovascular Diseases, Hyperlipidemias
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis
Standard of care
Sponsored by
About this trial
This is an interventional screening trial for Rheumatoid Arthritis focused on measuring Self-efficacy, Patient activation, Social Cognitive Theory, Peer coaches
Eligibility Criteria
Inclusion Criteria:
- Have RA
- Age between 40 and 75 years (inclusive)
- Provide a date of their next appointment with their rheumatologist
- Willing to work with a peer coach
- No recollection of having a cholesterol test within the past 2 years OR talking with a physician about cholesterol test results
- 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
- History of known cardiovascular disease
Sites / Locations
- Weill Cornell MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Peer coach guided online learning program
Self-administered online learning program
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects screened for hyperlipidemia
Self-reported
Number of subjects who initiated a statin
Self-reported
Secondary Outcome Measures
General Self-Efficacy Scale (GSF) score
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.
Patient Activation Measure (PAM) score - 13 item
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.
Routine Assessment of Patient Index Data (RAPID3) score
The scale consists of 12 score-able items. The range for items 1 through 10 are from 0 ("without any difficulty") to 3 ("unable to do"). Values 1 and 2 are assigned "with some difficulty" and "with much difficulty", respectively. Scores for items 1 through 10 are summed to give a total and a formal score is calculated from a provided formula to give the patient's functional score. Item 11 is a pain scale from 0 ("no pain") to 10 ("pain as bad as it can be") and the raw score is used as an evaluation of pain tolerance. Item 12 is a global estimate scale from 0 ("very well") to 10 ("very poorly") and the raw score is used as an evaluation of global estimate. 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).
Patient Health Questionnaire - 8 (PHQ-8) score
The scale consists of 8 items and each item score ranges from 0 ("not at all") to 3 ("nearly every day"). Values 1 and 2 are assigned "several days" and "more than half the days", respectively. Scores are summed across the 8 items. A score of 10 or greater is considered major depression, 20 or more is sever major depression.
Social Support Survey score
The scale consists of 19 items and each score ranges from 1 ("none of the time") to 5 ("all of the time"). Values 2, 3, and 4 are assigned "a little of the time", "some of the time", and "most of the time", respectively. The survey consists of 4 separate social support sub-scales and an overall functional social support index. To obtain a score for each sub-scale the average of the scores for each item is calculated and have a range of 1-5. To obtain an overall support index score, the average is calculated for both the first 18 items in the scale and a the last item in the scale and have a range of 1-5. Scale scores are transformed to a 0-100 scale using a formula. A higher score for an individual scale or for the overall support index 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.
Medication Understanding and Use Self-Efficacy Scale (MUSE) score
The scale consists of 8 items and each score ranges from 4 ("strongly agree") to 1 ("strongly disagree"). Values 2 and 3 are assigned "somewhat disagree" and "somewhat agree", respectively. The MUSE scale provides three scores: an overall scale score (8 items) and 2 sub-scale scores (4 items each). Possible scores for overall MUSE range from 8-32, while sub-scale scores range from 4-16. A higher overall MUSE score or sub-scale 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.
Full Information
NCT ID
NCT04488497
First Posted
July 22, 2020
Last Updated
August 17, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT04488497
Brief Title
Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:
Acronym
CARE RA
Official Title
Optimization of Hyperlipidemia Management Among Patients With Rheumatoid Arthritis: A Patient-centered Intervention Development
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Cardiovascular Diseases, Hyperlipidemias
Keywords
Self-efficacy, Patient activation, Social Cognitive Theory, Peer coaches
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peer coach guided online learning program
Arm Type
Experimental
Arm Title
Self-administered online learning program
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of subjects screened for hyperlipidemia
Description
Self-reported
Time Frame
3 months post-intervention
Title
Number of subjects who initiated a statin
Description
Self-reported
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
General Self-Efficacy Scale (GSF) score
Description
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.
Time Frame
3 months post-intervention
Title
Patient Activation Measure (PAM) score - 13 item
Description
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.
Time Frame
3 months post-intervention
Title
Routine Assessment of Patient Index Data (RAPID3) score
Description
The scale consists of 12 score-able items. The range for items 1 through 10 are from 0 ("without any difficulty") to 3 ("unable to do"). Values 1 and 2 are assigned "with some difficulty" and "with much difficulty", respectively. Scores for items 1 through 10 are summed to give a total and a formal score is calculated from a provided formula to give the patient's functional score. Item 11 is a pain scale from 0 ("no pain") to 10 ("pain as bad as it can be") and the raw score is used as an evaluation of pain tolerance. Item 12 is a global estimate scale from 0 ("very well") to 10 ("very poorly") and the raw score is used as an evaluation of global estimate. 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).
Time Frame
3 months post-intervention
Title
Patient Health Questionnaire - 8 (PHQ-8) score
Description
The scale consists of 8 items and each item score ranges from 0 ("not at all") to 3 ("nearly every day"). Values 1 and 2 are assigned "several days" and "more than half the days", respectively. Scores are summed across the 8 items. A score of 10 or greater is considered major depression, 20 or more is sever major depression.
Time Frame
3 months post-intervention
Title
Social Support Survey score
Description
The scale consists of 19 items and each score ranges from 1 ("none of the time") to 5 ("all of the time"). Values 2, 3, and 4 are assigned "a little of the time", "some of the time", and "most of the time", respectively. The survey consists of 4 separate social support sub-scales and an overall functional social support index. To obtain a score for each sub-scale the average of the scores for each item is calculated and have a range of 1-5. To obtain an overall support index score, the average is calculated for both the first 18 items in the scale and a the last item in the scale and have a range of 1-5. Scale scores are transformed to a 0-100 scale using a formula. A higher score for an individual scale or for the overall support index 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.
Time Frame
3 months post-intervention
Title
Medication Understanding and Use Self-Efficacy Scale (MUSE) score
Description
The scale consists of 8 items and each score ranges from 4 ("strongly agree") to 1 ("strongly disagree"). Values 2 and 3 are assigned "somewhat disagree" and "somewhat agree", respectively. The MUSE scale provides three scores: an overall scale score (8 items) and 2 sub-scale scores (4 items each). Possible scores for overall MUSE range from 8-32, while sub-scale scores range from 4-16. A higher overall MUSE score or sub-scale 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.
Time Frame
3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have RA
Age between 40 and 75 years (inclusive)
Provide a date of their next appointment with their rheumatologist
Willing to work with a peer coach
No recollection of having a cholesterol test within the past 2 years OR talking with a physician about cholesterol test results
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
History of known cardiovascular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Navarro-Millan, MD
Phone
646-962-5896
Email
yin9003@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Navarro-Milan, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Navarro-Millan, MD
Phone
646-962-5896
Email
yin9003@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Iris Navarro-Millan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35428359
Citation
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.
Results Reference
derived
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