<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/NCT03020316</url>
  </required_header>
  <id_info>
    <org_study_id>1507016382</org_study_id>
    <nct_id>NCT03020316</nct_id>
  </id_info>
  <brief_title>Peer Mentored Approaches For Men And Women With Coronary Artery Disease (&quot;4Steps&quot;)</brief_title>
  <official_title>Peer Mentored Approaches For Men And Women With Coronary Artery Disease (&quot;4Steps&quot;)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This study will be a pilot prospective randomized study using a peer mentor with or without&#xD;
      Transcendental Meditation as compared to usual care for men and women with a new diagnosis of&#xD;
      coronary artery disease (CAD). The study is designed to explore between cohort comparisons of&#xD;
      perceived stress and a number of additional outcomes. The results of this pilot study will be&#xD;
      used in the design of larger future trials.&#xD;
&#xD;
      The target population is adult men and women with a new diagnosis of CAD made on the basis of&#xD;
      a myocardial infarction, coronary revascularization procedure, acute coronary syndrome, or&#xD;
      imaging test suggestive of CAD.&#xD;
&#xD;
      The overall hypothesis of this proposal is that the addition of a peer mentor and training in&#xD;
      Transcendental Meditation to usual care will improve perceived stress and medication&#xD;
      adherence for men and women with newly diagnosed CAD as compared with usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall hypothesis of this proposal is that the addition of a peer mentor and training in&#xD;
      Transcendental Meditation to usual care will improve perceived stress and medication&#xD;
      adherence for men and women with newly diagnosed CAD as compared with usual care.&#xD;
&#xD;
      Participants will be &quot;randomized&quot; into one of two study groups:&#xD;
&#xD;
      Arm 1 - Standard Of Care (SOC) Arm 3 - SOC, assignment of a peer mentor, and the opportunity&#xD;
      to receive training in transcendental meditation&#xD;
&#xD;
      We are no longer enrolling in Arm 2 of the study (SOC and subjects addition of a peer&#xD;
      mentor).&#xD;
&#xD;
      Subjects will be assessed at baseline, 1 month, 6 months, and 12 months with surveys and&#xD;
      assessments.&#xD;
&#xD;
      SOC may include routine outpatient physician assessment, preventive medications with&#xD;
      appropriate titration, routine blood draws, advice on lifestyle change, referral to cardiac&#xD;
      rehabilitation, use of commercially available medical apps.&#xD;
&#xD;
      Investigation - use of peer mentor and use of transcendental meditation.&#xD;
&#xD;
        1. Peer mentor: These are volunteers with CAD, who will undergo training prior to be&#xD;
           assigned a mentee. Content of the training will focus on a review of health counseling,&#xD;
           basics of CAD pathophysiology and medications, information on situations where the&#xD;
           mentor should advise the subject to contact her doctor, and confidentiality. Mentors are&#xD;
           intended to provide psychosocial and limited educational support for subjects.&#xD;
&#xD;
        2. Transcendental meditation (TM). TM is a standardized meditation technique done 20&#xD;
           minutes twice each day while sitting with the eyes closed. Although data are&#xD;
           heterogeneous, TM has been demonstrated to reduce blood pressure in several small&#xD;
           studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">November 22, 2019</completion_date>
  <primary_completion_date type="Actual">October 6, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>52 weeks</time_frame>
    <description>Cohen Perceived Stress Scale (PSS-10)&#xD;
Each item is rated on a 5-point scale ranging from never (0) to almost always (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.&#xD;
Total scale range: 0-40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence (ARMS-7)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Adherence to Refills and Medication Scale (ARMS-7)&#xD;
Total scale range: 7-28; subscale range: 1-4. Scores can be treated as a continuous measure or dichotomized as 7 or &gt;7. Lower scores indicate better adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence (VAS)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Visual analog scale for medication adherence&#xD;
Total scale range: 0-100%. Higher percentage indicates better adherence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>52 weeks</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D)&#xD;
Total scale range: 0-60. Total score of 16 or higher is considered depressed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>52 weeks</time_frame>
    <description>Height (m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>52 weeks</time_frame>
    <description>Weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>52 weeks</time_frame>
    <description>Blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>52 weeks</time_frame>
    <description>Heart rate (beats/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>52 weeks</time_frame>
    <description>Waist circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid panel results</measure>
    <time_frame>52 weeks</time_frame>
    <description>Total cholesterol, LDL, HDL, triglycerides (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>52 weeks</time_frame>
    <description>Fasting plasma glucose levels (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>52 weeks</time_frame>
    <description>Was the subject readmitted or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical activity</measure>
    <time_frame>52 weeks</time_frame>
    <description>Measured by International Physical Activity Questionnaire (IPAQ)&#xD;
Survey does not include a range of possible values. Based on verbal description of activity and participation time, populations are divided into 3 proposed levels of physical activity: inactive, minimally active, and HEPA active.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and manner of contacts between participants and mentors</measure>
    <time_frame>52 weeks</time_frame>
    <description>Verbal description</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant feedback about mentorship and TM</measure>
    <time_frame>52 weeks</time_frame>
    <description>Verbal description</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant knowledge about CAD</measure>
    <time_frame>52 weeks</time_frame>
    <description>Verbal description</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will be encouraged to follow-up with their primary physicians.&#xD;
Subjects will be informed that they will be periodically contacted by telephone and/or email by the research team for future assessments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer Mentor &amp; Transcendental Meditation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be assigned a peer mentor (a volunteer with CAD). After initial contact, the peer mentor and subject will be encouraged to communicate at whatever frequency or medium they deem most appropriate. This may include speaking by telephone, personal email or meeting in person. Mentors (and subjects if willing) will be asked to keep a log of such contacts, which will be provided to the study staff at interval reassessments.&#xD;
In addition to the peer mentor, subjects will be instructed in transcendental meditation (TM) in the standard manner by a trained TM instructor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer Mentor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We are no longer recruiting in this arm.&#xD;
Subjects will be assigned a peer mentor (a volunteer with CAD). After initial contact, the peer mentor and subject will be encouraged to communicate at whatever frequency or medium they deem most appropriate. This may include speaking by telephone, personal email or meeting in person. Mentors (and subjects if willing) will be asked to keep a log of such contacts, which will be provided to the study staff at interval reassessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer Mentor</intervention_name>
    <description>A volunteer with a similar disease as the subject</description>
    <arm_group_label>Peer Mentor</arm_group_label>
    <arm_group_label>Peer Mentor &amp; Transcendental Meditation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Transcendental Meditation</intervention_name>
    <description>A meditation technique</description>
    <arm_group_label>Peer Mentor &amp; Transcendental Meditation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Participants:&#xD;
&#xD;
          -  Men and women aged 18-90&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Newly diagnosed with CAD (myocardial infarction [MI], percutaneous coronary&#xD;
             intervention [PCI], coronary artery bypass graft [CABG]), acute coronary syndrome, or&#xD;
             any imaging test suggestive of CAD).&#xD;
&#xD;
        For Mentors:&#xD;
&#xD;
        (Male mentors will be paired with male participants, and female mentors will be paired with&#xD;
        female participants.)&#xD;
&#xD;
          -  Men and women aged 18-90&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Established (greater than 1yr prior to study) diagnosis of CAD (myocardial infarction&#xD;
             [MI], percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG]&#xD;
             acute coronary syndrome, or imaging test suggestive of CAD).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For Participants:&#xD;
&#xD;
          -  Previously diagnosed CAD (MI, PCI, CABG, acute coronary syndrome or imaging test&#xD;
             suggestive of CAD)&#xD;
&#xD;
          -  Inability or unwillingness to provide written consent&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Prior formal training and practice of TM&#xD;
&#xD;
        For Mentors:&#xD;
&#xD;
          -  Inability or unwillingness to provide written consent&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica M Peña, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HeartHealth - Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 26, 2015</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03020316
org study id: 1507016382
nct id: NCT03020316
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be a pilot prospective randomized study using a peer mentor with or without
      Transcendental Meditation as compared to usual care for men and women with a new diagnosis of
      coronary artery disease (CAD). The study is designed to explore between cohort comparisons of
      perceived stress and a number of additional outcomes. The results of this pilot study will be
      used in the design of larger future trials.

      The target population is adult men and women with a new diagnosis of CAD made on the basis of
      a myocardial infarction, coronary revascularization procedure, acute coronary syndrome, or
      imaging test suggestive of CAD.

      The overall hypothesis of this proposal is that the addition of a peer mentor and training in
      Transcendental Meditation to usual care will improve perceived stress and medication
      adherence for men and women with newly diagnosed CAD as compared with usual care.
The overall hypothesis of this proposal is that the addition of a peer mentor and training in
      Transcendental Meditation to usual care will improve perceived stress and medication
      adherence for men and women with newly diagnosed CAD as compared with usual care.

      Participants will be "randomized" into one of two study groups:

      Arm 1 - Standard Of Care (SOC) Arm 3 - SOC, assignment of a peer mentor, and the opportunity
      to receive training in transcendental meditation

      We are no longer enrolling in Arm 2 of the study (SOC and subjects addition of a peer
      mentor).

      Subjects will be assessed at baseline, 1 month, 6 months, and 12 months with surveys and
      assessments.

      SOC may include routine outpatient physician assessment, preventive medications with
      appropriate titration, routine blood draws, advice on lifestyle change, referral to cardiac
      rehabilitation, use of commercially available medical apps.

      Investigation - use of peer mentor and use of transcendental meditation.

        1. Peer mentor: These are volunteers with CAD, who will undergo training prior to be
           assigned a mentee. Content of the training will focus on a review of health counseling,
           basics of CAD pathophysiology and medications, information on situations where the
           mentor should advise the subject to contact her doctor, and confidentiality. Mentors are
           intended to provide psychosocial and limited educational support for subjects.

        2. Transcendental meditation (TM). TM is a standardized meditation technique done 20
           minutes twice each day while sitting with the eyes closed. Although data are
           heterogeneous, TM has been demonstrated to reduce blood pressure in several small
           studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Perceived Stress
time frame: 52 weeks
description: Cohen Perceived Stress Scale (PSS-10)
Each item is rated on a 5-point scale ranging from never (0) to almost always (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.
Total scale range: 0-40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress.
measure: Medication Adherence (ARMS-7)
time frame: 52 weeks
description: Adherence to Refills and Medication Scale (ARMS-7)
Total scale range: 7-28; subscale range: 1-4. Scores can be treated as a continuous measure or dichotomized as 7 or >7. Lower scores indicate better adherence.
measure: Medication Adherence (VAS)
time frame: 52 weeks
description: Visual analog scale for medication adherence
Total scale range: 0-100%. Higher percentage indicates better adherence.
measure: Depressive Symptoms
time frame: 52 weeks
description: Center for Epidemiologic Studies Depression Scale (CES-D)
Total scale range: 0-60. Total score of 16 or higher is considered depressed.
measure: Height
time frame: 52 weeks
description: Height (m)
measure: Weight
time frame: 52 weeks
description: Weight (kg)
measure: Blood pressure
time frame: 52 weeks
description: Blood pressure (mmHg)
measure: Heart rate
time frame: 52 weeks
description: Heart rate (beats/min)
measure: Waist circumference
time frame: 52 weeks
description: Waist circumference (cm)
measure: Lipid panel results
time frame: 52 weeks
description: Total cholesterol, LDL, HDL, triglycerides (mg/dL)
measure: Fasting plasma glucose
time frame: 52 weeks
description: Fasting plasma glucose levels (mg/dL)
measure: Hospital readmission
time frame: 52 weeks
description: Was the subject readmitted or not
measure: Changes in physical activity
time frame: 52 weeks
description: Measured by International Physical Activity Questionnaire (IPAQ)
Survey does not include a range of possible values. Based on verbal description of activity and participation time, populations are divided into 3 proposed levels of physical activity: inactive, minimally active, and HEPA active.
measure: Number and manner of contacts between participants and mentors
time frame: 52 weeks
description: Verbal description
measure: Participant feedback about mentorship and TM
time frame: 52 weeks
description: Verbal description
measure: Participant knowledge about CAD
time frame: 52 weeks
description: Verbal description
arm group label: Usual Care
arm group type: No Intervention
description: Subjects will be encouraged to follow-up with their primary physicians.
Subjects will be informed that they will be periodically contacted by telephone and/or email by the research team for future assessments.
arm group label: Peer Mentor & Transcendental Meditation
arm group type: Active Comparator
description: Subjects will be assigned a peer mentor (a volunteer with CAD). After initial contact, the peer mentor and subject will be encouraged to communicate at whatever frequency or medium they deem most appropriate. This may include speaking by telephone, personal email or meeting in person. Mentors (and subjects if willing) will be asked to keep a log of such contacts, which will be provided to the study staff at interval reassessments.
In addition to the peer mentor, subjects will be instructed in transcendental meditation (TM) in the standard manner by a trained TM instructor.
arm group label: Peer Mentor
arm group type: Active Comparator
description: We are no longer recruiting in this arm.
Subjects will be assigned a peer mentor (a volunteer with CAD). After initial contact, the peer mentor and subject will be encouraged to communicate at whatever frequency or medium they deem most appropriate. This may include speaking by telephone, personal email or meeting in person. Mentors (and subjects if willing) will be asked to keep a log of such contacts, which will be provided to the study staff at interval reassessments.
intervention type: Behavioral
intervention name: Peer Mentor
description: A volunteer with a similar disease as the subject
arm group label: Peer Mentor
arm group label: Peer Mentor & Transcendental Meditation
intervention type: Behavioral
intervention name: Transcendental Meditation
description: A meditation technique
arm group label: Peer Mentor & Transcendental Meditation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jessica M Peña, MD, MPH
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: Undecided