<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488497</url>
  </required_header>
  <id_info>
    <org_study_id>1703018030</org_study_id>
    <secondary_id>K23AR068449</secondary_id>
    <nct_id>NCT04488497</nct_id>
  </id_info>
  <brief_title>Cardiovascular Risk Assessment for Patients With Rheumatoid Arthritis Arthritis:</brief_title>
  <acronym>CARE RA</acronym>
  <official_title>Optimization of Hyperlipidemia Management Among Patients With Rheumatoid Arthritis: A Patient-centered Intervention Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      One of the greatest success stories in rheumatology - the achievement of rheumatoid arthritis&#xD;
      (RA) remission - is tempered by the fact that individuals with RA are dramatically under&#xD;
      evaluated and under treated to reduce the risk for heart attacks and strokes. This project&#xD;
      will build the foundation for an intervention that will test the hypothesis that the&#xD;
      patient-centered intervention tailored to patients with RA to improve hyperlipidemia&#xD;
      screening and treatment, thereby decreasing the risk for heart attacks and strokes.&#xD;
&#xD;
      The aims of this proposal are:&#xD;
&#xD;
      Aim 1: To identify patient and physician barriers to lower the risk for heart attacks and&#xD;
      strokes in patients with RA.&#xD;
&#xD;
      Aim 2: To develop an intervention designed to optimize lipid screening and management in RA&#xD;
      patients. This will consist of patient education and a decision support program to facilitate&#xD;
      screening for hyperlipidemia (high cholesterol level) or initiation of medications to lower&#xD;
      cholesterol (primary outcome) and self-efficacy (level of confidence in performing a task) in&#xD;
      taking medications to lower cholesterol secondary outcome).&#xD;
&#xD;
      Aim 3: To pilot test the efficacy and feasibility of intervention developed in Aim 2. The&#xD;
      investigators will apply methods related to clinical trials to test the feasibility of the&#xD;
      newly developed intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 27, 2021</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects screened for hyperlipidemia</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Self-reported</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects who initiated a statin</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>Self-reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General Self-Efficacy Scale (GSF) score</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>The scale consists of 10 items and each item score ranges from 1 (&quot;not at all true&quot;) to 4 (&quot;exactly true&quot;). Values 2 and 3 are assigned &quot;barely true&quot; and &quot;moderately true&quot;, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure (PAM) score - 13 item</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>The scale consists of 13 items and each item score ranges from 0 (&quot;not applicable&quot;) to 4 (&quot;agree strongly&quot;). Values 1, 2, and 3 are assigned &quot;disagree strongly&quot;, &quot;disagree&quot;, and &quot;agree&quot;, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Routine Assessment of Patient Index Data (RAPID3) score</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>The scale consists of 12 score-able items. The range for items 1 through 10 are from 0 (&quot;without any difficulty&quot;) to 3 (&quot;unable to do&quot;). Values 1 and 2 are assigned &quot;with some difficulty&quot; and &quot;with much difficulty&quot;, 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 (&quot;no pain&quot;) to 10 (&quot;pain as bad as it can be&quot;) and the raw score is used as an evaluation of pain tolerance. Item 12 is a global estimate scale from 0 (&quot;very well&quot;) to 10 (&quot;very poorly&quot;) 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire - 8 (PHQ-8) score</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>The scale consists of 8 items and each item score ranges from 0 (&quot;not at all&quot;) to 3 (&quot;nearly every day&quot;). Values 1 and 2 are assigned &quot;several days&quot; and &quot;more than half the days&quot;, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support Survey score</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>The scale consists of 19 items and each score ranges from 1 (&quot;none of the time&quot;) to 5 (&quot;all of the time&quot;). Values 2, 3, and 4 are assigned &quot;a little of the time&quot;, &quot;some of the time&quot;, and &quot;most of the time&quot;, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Understanding and Use Self-Efficacy Scale (MUSE) score</measure>
    <time_frame>3 months post-intervention</time_frame>
    <description>The scale consists of 8 items and each score ranges from 4 (&quot;strongly agree&quot;) to 1 (&quot;strongly disagree&quot;). Values 2 and 3 are assigned &quot;somewhat disagree&quot; and &quot;somewhat agree&quot;, 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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>Peer coach guided online learning program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-administered online learning program</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis</intervention_name>
    <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.</description>
    <arm_group_label>Peer coach guided online learning program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <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.</description>
    <arm_group_label>Self-administered online learning program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have RA&#xD;
&#xD;
          -  Age between 40 and 75 years (inclusive)&#xD;
&#xD;
          -  Provide a date of their next appointment with their rheumatologist&#xD;
&#xD;
          -  Willing to work with a peer coach&#xD;
&#xD;
          -  No recollection of having a cholesterol test within the past 2 years OR talking with a&#xD;
             physician about cholesterol test results&#xD;
&#xD;
          -  Speaks English&#xD;
&#xD;
          -  Have a phone&#xD;
&#xD;
          -  Has access to the internet&#xD;
&#xD;
          -  Resides or lives in the US&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not have rheumatoid arthritis&#xD;
&#xD;
          -  Younger than age 40 or older than age 75&#xD;
&#xD;
          -  Taking a statin&#xD;
&#xD;
          -  History of known cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iris Navarro-Milan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Iris Navarro-Millan, MD</last_name>
    <phone>646-962-5896</phone>
    <email>yin9003@med.cornell.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Iris Navarro-Millan, MD</last_name>
      <phone>646-962-5896</phone>
      <email>yin9003@med.cornell.edu</email>
    </contact>
    <investigator>
      <last_name>Iris Navarro-Millan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Self-efficacy</keyword>
  <keyword>Patient activation</keyword>
  <keyword>Social Cognitive Theory</keyword>
  <keyword>Peer coaches</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488497
org study id: 1703018030
secondary id: K23AR068449
nct id: NCT04488497
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Number of subjects screened for hyperlipidemia
time frame: 3 months post-intervention
description: Self-reported
measure: Number of subjects who initiated a statin
time frame: 3 months post-intervention
description: Self-reported
measure: General Self-Efficacy Scale (GSF) score
time frame: 3 months post-intervention
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.
measure: Patient Activation Measure (PAM) score - 13 item
time frame: 3 months post-intervention
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.
measure: Routine Assessment of Patient Index Data (RAPID3) score
time frame: 3 months post-intervention
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).
measure: Patient Health Questionnaire - 8 (PHQ-8) score
time frame: 3 months post-intervention
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.
measure: Social Support Survey score
time frame: 3 months post-intervention
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.
measure: Medication Understanding and Use Self-Efficacy Scale (MUSE) score
time frame: 3 months post-intervention
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.
arm group label: Peer coach guided online learning program
arm group type: Experimental
arm group label: Self-administered online learning program
arm group type: Placebo Comparator
intervention type: Behavioral
intervention name: Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis
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.
arm group label: Peer coach guided online learning program
intervention type: Behavioral
intervention name: Standard of care
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.
arm group label: Self-administered online learning program
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Iris Navarro-Milan, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Iris Navarro-Millan, MD
phone: 646-962-5896
email: yin9003@med.cornell.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Cardiovascular Diseases
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
sharing ipd: No