<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/NCT02204449</url>
  </required_header>
  <id_info>
    <org_study_id>13-7183</org_study_id>
    <nct_id>NCT02204449</nct_id>
  </id_info>
  <brief_title>Cardiac Rehabilitation Peer Mentorship</brief_title>
  <official_title>Mentorship to Promote Cardiac Rehabilitation Enrollment: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>York University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study is a randomized controlled trial, being conducted at two hospitals in&#xD;
      Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an&#xD;
      intervention group, in which they will receive mentorship from a volunteer cardiac&#xD;
      rehabilitation peer mentor, and a control group, in which they will receive usual care.&#xD;
      Patients in both groups will be tracked to determine if they are referred to cardiac&#xD;
      rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to&#xD;
      cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac&#xD;
      rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac&#xD;
      rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study will be a randomized controlled trial in which cardiac inpatients will be&#xD;
      randomized to either receive the intervention (cardiac rehabilitation peer mentorship) or be&#xD;
      in the control group (receive usual care). After consent is obtained cardiac patients in the&#xD;
      intervention group will be visited, at the hospital bedside, by trained volunteer cardiac&#xD;
      rehabilitation peer mentors (i.e., individuals who have completed cardiac rehabilitation) who&#xD;
      will provide the patients with information on cardiac rehabilitation as well as encourage the&#xD;
      patients to obtain a referral from their healthcare provider. During this visit the cardiac&#xD;
      rehabilitation peer mentor will also obtain agreement from the patient to call the patient at&#xD;
      home two weeks after their discharge. Those in the control group will not be visited by&#xD;
      cardiac rehabilitation peer mentors.&#xD;
&#xD;
      One week after discharge the cardiac rehabilitation peer mentors will mail the patients in&#xD;
      the intervention a get-well soon card reminding the patient of the visit, giving them more&#xD;
      information about the cardiac rehabilitation program, and reminding them of their future&#xD;
      scheduled phone call. Two weeks after patients' discharge cardiac rehabilitation peer mentors&#xD;
      will call the patients in the intervention group. At this point they will assess how the&#xD;
      patient is doing, if they were referred to cardiac rehabilitation and if they enrolled. Any&#xD;
      possible barriers the patients have to attending cardiac rehabilitation will also be&#xD;
      discussed.&#xD;
&#xD;
      Eight weeks post-discharge, patient referral and enrolment will be ascertained by a research&#xD;
      assistant blinded to random assignment. Statistical analyses will be conducted to determine&#xD;
      any differences between the two groups as well as to determine any differences between men&#xD;
      and women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Rehabilitation Enrollment</measure>
    <time_frame>12 weeks after patient is discharged from hospital</time_frame>
    <description>A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac Rehabilitation Referral</measure>
    <time_frame>12 weeks after patient has been discharged from hospital</time_frame>
    <description>A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cardiac Rehabilitation Enrollment in Site Closer to Home</measure>
    <time_frame>8 weeks after patient is discharged from hospital</time_frame>
    <description>A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Coronary Artery Bypass Graft Surgery, With or Without Valve Surgery</condition>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Chronic Stable Heart Failure</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Cardiac Rehabilitation Peer Mentorship</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral, and arrange a time to call the patient/participant at home to find out about their CR progress. One week post-discharge the peer mentor will mail a card to the patient to remind them of the planned call. Two weeks post-discharge the peer mentor will call the patient at home to determine if they were referred and if they are planning to attend CR. If any barriers are stated by patient the peer mentors will work with the patient to develop possible solutions. Patients can request up to two additional phone calls from the mentors.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cardiac Rehabilitation Peer Mentorship</intervention_name>
    <arm_group_label>Cardiac Rehabilitation Peer Mentorship</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any condition indicated for cardiac rehabilitation: Acute coronary syndrome,&#xD;
             percutaneous coronary intervention, coronary artery bypass graft +/- valve surgery or&#xD;
             procedure (e.g., TAVI), heart transplant, ventricular assist device, heart failure,&#xD;
             arrhythmia, rhythm device (i.e. implantable cardioverter-defibrillator, cardiac&#xD;
             resynchronization therapy, pacemaker), congenital heart disease, minor non-disabling&#xD;
             stroke or transient ischemic attack (i.e., can ambulate), peripheral vascular disease&#xD;
&#xD;
          -  Proficiency in English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any musculoskeletal, neuromuscular, visual, cognitive or non-dysphoric psychiatric&#xD;
             condition, or any serious or terminal illness not otherwise specified which would&#xD;
             preclude CR eligibility based on CR guidelines&#xD;
&#xD;
          -  Being discharged to long-term care&#xD;
&#xD;
          -  Inability to ambulate (i.e. walk unaided at 2mph)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry Grace, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>York University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>June 3, 2015</results_first_submitted>
  <results_first_submitted_qc>June 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 22, 2015</results_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>York University</investigator_affiliation>
    <investigator_full_name>Sherry Grace</investigator_full_name>
    <investigator_title>Full Professor</investigator_title>
  </responsible_party>
  <keyword>cardiac rehabilitation</keyword>
  <keyword>peer mentorship</keyword>
  <keyword>healthcare utilization</keyword>
  <keyword>continuity of cardiac care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cardiac Rehabilitation Peer Mentorship</title>
          <description>Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.&#xD;
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.&#xD;
Cardiac Rehabilitation Peer Mentorship</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cardiac Rehabilitation Peer Mentorship</title>
          <description>Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.&#xD;
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.&#xD;
Cardiac Rehabilitation Peer Mentorship</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="93"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.7" spread="16.5"/>
                    <measurement group_id="B2" value="62.6" spread="13.1"/>
                    <measurement group_id="B3" value="62.7" spread="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cardiac Rehabilitation Enrollment</title>
        <description>A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.</description>
        <time_frame>12 weeks after patient is discharged from hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cardiac Rehabilitation Peer Mentorship</title>
            <description>Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.&#xD;
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.&#xD;
Cardiac Rehabilitation Peer Mentorship</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Rehabilitation Enrollment</title>
          <description>A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Rehabilitation Referral</title>
        <description>A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.</description>
        <time_frame>12 weeks after patient has been discharged from hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cardiac Rehabilitation Peer Mentorship</title>
            <description>Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.&#xD;
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.&#xD;
Cardiac Rehabilitation Peer Mentorship</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Rehabilitation Referral</title>
          <description>A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cardiac Rehabilitation Enrollment in Site Closer to Home</title>
        <description>A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.</description>
        <time_frame>8 weeks after patient is discharged from hospital</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cardiac Rehabilitation Peer Mentorship</title>
            <description>Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.&#xD;
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.&#xD;
Cardiac Rehabilitation Peer Mentorship</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Rehabilitation Enrollment in Site Closer to Home</title>
          <description>A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cardiac Rehabilitation Peer Mentorship</title>
          <description>Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.&#xD;
One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.&#xD;
Cardiac Rehabilitation Peer Mentorship</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Sherry Grace</name_or_title>
      <organization>UHN Toronto</organization>
      <phone>416.736.2100 ext 22364</phone>
      <email>sgrace@yorku.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02204449
org study id: 13-7183
nct id: NCT02204449
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The current study is a randomized controlled trial, being conducted at two hospitals in
      Toronto, Ontario, Canada, involving the randomization of cardiac inpatients into an
      intervention group, in which they will receive mentorship from a volunteer cardiac
      rehabilitation peer mentor, and a control group, in which they will receive usual care.
      Patients in both groups will be tracked to determine if they are referred to cardiac
      rehabilitation and if they enroll in cardiac rehabilitation. We hypothesize that compared to
      cardiac inpatients who receive usual care, those cardiac inpatients who receive cardiac
      rehabilitation peer mentorship will be more likely to be referred to and enroll in cardiac
      rehabilitation.
The current study will be a randomized controlled trial in which cardiac inpatients will be
      randomized to either receive the intervention (cardiac rehabilitation peer mentorship) or be
      in the control group (receive usual care). After consent is obtained cardiac patients in the
      intervention group will be visited, at the hospital bedside, by trained volunteer cardiac
      rehabilitation peer mentors (i.e., individuals who have completed cardiac rehabilitation) who
      will provide the patients with information on cardiac rehabilitation as well as encourage the
      patients to obtain a referral from their healthcare provider. During this visit the cardiac
      rehabilitation peer mentor will also obtain agreement from the patient to call the patient at
      home two weeks after their discharge. Those in the control group will not be visited by
      cardiac rehabilitation peer mentors.

      One week after discharge the cardiac rehabilitation peer mentors will mail the patients in
      the intervention a get-well soon card reminding the patient of the visit, giving them more
      information about the cardiac rehabilitation program, and reminding them of their future
      scheduled phone call. Two weeks after patients' discharge cardiac rehabilitation peer mentors
      will call the patients in the intervention group. At this point they will assess how the
      patient is doing, if they were referred to cardiac rehabilitation and if they enrolled. Any
      possible barriers the patients have to attending cardiac rehabilitation will also be
      discussed.

      Eight weeks post-discharge, patient referral and enrolment will be ascertained by a research
      assistant blinded to random assignment. Statistical analyses will be conducted to determine
      any differences between the two groups as well as to determine any differences between men
      and women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Cardiac Rehabilitation Enrollment
time frame: 12 weeks after patient is discharged from hospital
description: A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.
measure: Cardiac Rehabilitation Referral
time frame: 12 weeks after patient has been discharged from hospital
description: A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.
measure: Cardiac Rehabilitation Enrollment in Site Closer to Home
time frame: 8 weeks after patient is discharged from hospital
description: A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.
arm group label: Cardiac Rehabilitation Peer Mentorship
arm group type: Experimental
description: Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral, and arrange a time to call the patient/participant at home to find out about their CR progress. One week post-discharge the peer mentor will mail a card to the patient to remind them of the planned call. Two weeks post-discharge the peer mentor will call the patient at home to determine if they were referred and if they are planning to attend CR. If any barriers are stated by patient the peer mentors will work with the patient to develop possible solutions. Patients can request up to two additional phone calls from the mentors.
arm group label: Usual Care
arm group type: No Intervention
description: Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
intervention type: Behavioral
intervention name: Cardiac Rehabilitation Peer Mentorship
arm group label: Cardiac Rehabilitation Peer Mentorship
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sherry Grace, PhD
role: Principal Investigator
affiliation: York University
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: York University
investigator full name: Sherry Grace
investigator title: Full Professor
mesh term: Coronary Artery Disease
mesh term: Acute Coronary Syndrome
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 