<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/NCT01725815</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00047631a</org_study_id>
    <secondary_id>1R01MH090584-01A1</secondary_id>
    <nct_id>NCT01725815</nct_id>
  </id_info>
  <brief_title>The Health Access and Recovery Peer Program</brief_title>
  <acronym>HARP</acronym>
  <official_title>A Peer-Led, Medical Disease Self-Management Program for Mental Health Consumers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals with serious mental illnesses (SMI) face high rates of medical comorbidity as&#xD;
      well as challenges in managing these conditions. A growing workforce of certified peer&#xD;
      specialists is available to help these individuals more effectively manage their health and&#xD;
      health care. However, there is little existing research examining the effectiveness of&#xD;
      peer-led medical self-management programs for this population. in this trial, participants&#xD;
      were randomized to either the Health and Recovery Peer program (HARP), a medical disease&#xD;
      self-management program led by certified peer specialists, or to care as usual. Assessments&#xD;
      were conducted at baseline, 3 months, and 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and&#xD;
      also challenges in effectively managing these health problems. There is an urgent need to&#xD;
      develop self-management strategies that allow persons with SMI to more effectively manage&#xD;
      their chronic medical illnesses.&#xD;
&#xD;
      In general populations, peer-led disease self-management interventions have been demonstrated&#xD;
      to be feasible, effective, scalable, and to lead to sustainable improvements in&#xD;
      self-management and health outcomes. With funding from an R34 intervention development grant&#xD;
      from NIMH, the study team has developed and piloted a modified version of the most widely&#xD;
      tested and used peer-led self management program, the Chronic Disease Self-Management Program&#xD;
      (CDSMP), for persons with serious mental illness. Two pilot tests of this intervention, the&#xD;
      Health and Recovery Peer (HARP) program, demonstrated that the program can be implemented&#xD;
      with high engagement, retention, and program fidelity, and can result in effect sizes across&#xD;
      a range of outcomes comparable to or greater than those seen in general medical populations.&#xD;
&#xD;
      This application proposes to conduct a fully-powered, multisite trial of the HARP program. A&#xD;
      total of 400 individuals with serious mental illnesses and one or more chronic medical&#xD;
      condition will be recruited from three diverse community mental health clinics in the Atlanta&#xD;
      metro region and randomized to the HARP program or usual care. For individuals in the HARP&#xD;
      program, two peer educators with SMI and one or more chronic medical condition will lead a&#xD;
      six-session, six-week manualized intervention, which helps participants become more effective&#xD;
      managers of their chronic illnesses. Follow-up interviews and chart reviews at 3 months, 6&#xD;
      months and one year will assess changes in clinical outcomes, improvement in generic and&#xD;
      disease-specific measures of illness self-management, and quality of care. During the final&#xD;
      phase of the study, a dissemination strategy building on the CDSMP training infrastructure&#xD;
      will allow program participants to lead HARP groups.&#xD;
&#xD;
      This study will establish the first fully peer-led, evidence-based intervention for improving&#xD;
      physical self-management in this vulnerable population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2016</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Related Quality of Life (HRQOL)</measure>
    <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>The short form-36-item (SF-36) Physical component score (PCS) is a measure of HRQOL constructed for use in the Medical Outcomes Study that rely upon patient self-reporting and reflects the physical functioning. The scores ranges from 0-100 with higher scores indicating greater levels of physical functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral Activation</measure>
    <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>Behavioral Activation was measured using the Patient Activation Measure (PAM), an instrument which has been found to be reliable and valid across a wide range of patient populations. The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. Possible scores range from 0 to 100, with higher scores indicating greater patient activation (better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>Dietary intake was assessed with the Block Fat-Sugar-Fruit-Vegetable Screener, which is a validated 55-item scale assessing both frequency and quantity of food intake based on typical eating habits. Possible scores range from 0 to 68, with higher scores indicating greater consumption of fat (worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
    <description>Medication Adherence was assessed using the Morisky scale, a 4-item questionnaire that has been shown to have strong content and predictive validity in hypertension,cardiovascular disease,and diabetes. Possible scores range from 0 to 4 with lower scores indicating greater medication adherence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Hypertension</condition>
  <condition>Arthritis</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Hepatitis</condition>
  <condition>Diabetes</condition>
  <condition>Asthma</condition>
  <condition>Hyperlipidemia</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>HARP Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention: Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HARP Intervention</intervention_name>
    <description>The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
    <arm_group_label>HARP Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  On CMHC roster of active patients.&#xD;
&#xD;
          -  Presence of a serious mental illness (schizophrenia, schizoaffective disorder, bipolar&#xD;
             disorder, major depression, obsessive-compulsive disorder, or post-traumatic stress&#xD;
             disorder&#xD;
&#xD;
          -  Chronic Medical Condition as noted in the CMHC chart or via self-report:&#xD;
             (hypertension; arthritis; heart disease; diabetes; and asthma/COPD),&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment based on a score of &gt; 3 on a 6-item, validated screener developed&#xD;
             for clinical research&#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>Benjamin Druss, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Fulton Community Mental Health Center at Grady Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>April 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <results_first_submitted>August 14, 2019</results_first_submitted>
  <results_first_submitted_qc>September 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 9, 2019</results_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Benjamin Druss</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 26, 2010</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT01725815/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HARP Intervention</title>
          <description>HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
        </group>
        <group group_id="P2">
          <title>No Intervention: Control</title>
          <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="202"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="202"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HARP Intervention</title>
          <description>HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
        </group>
        <group group_id="B2">
          <title>No Intervention: Control</title>
          <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</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="198"/>
            <count group_id="B2" value="202"/>
            <count group_id="B3" value="400"/>
          </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="49.74" spread="8.72"/>
                    <measurement group_id="B2" value="49.69" spread="9.51"/>
                    <measurement group_id="B3" value="49.71" spread="9.11"/>
                  </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="132"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="255"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="264"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="198"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total annual Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>$0-$5000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$5000-$10000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$10000-$15000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;$15000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Medicaid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medicare</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Private insurance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart Disease/CAD/CHD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperlipidemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="133"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthritis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthma/COPD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HIV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Mental Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Schizophrenia/Schizoaffective</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bipolar Disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Obsessive Compulsive Disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Traumatic stress Disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Health Related Quality of Life (HRQOL)</title>
        <description>The short form-36-item (SF-36) Physical component score (PCS) is a measure of HRQOL constructed for use in the Medical Outcomes Study that rely upon patient self-reporting and reflects the physical functioning. The scores ranges from 0-100 with higher scores indicating greater levels of physical functioning.</description>
        <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HARP Intervention</title>
            <description>HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention: Control</title>
            <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life (HRQOL)</title>
          <description>The short form-36-item (SF-36) Physical component score (PCS) is a measure of HRQOL constructed for use in the Medical Outcomes Study that rely upon patient self-reporting and reflects the physical functioning. The scores ranges from 0-100 with higher scores indicating greater levels of physical functioning.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.73" spread="10.92"/>
                    <measurement group_id="O2" value="32.74" spread="11.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.49" spread="11.15"/>
                    <measurement group_id="O2" value="33.89" spread="10.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.42" spread="11.02"/>
                    <measurement group_id="O2" value="34.15" spread="11.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Behavioral Activation</title>
        <description>Behavioral Activation was measured using the Patient Activation Measure (PAM), an instrument which has been found to be reliable and valid across a wide range of patient populations. The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. Possible scores range from 0 to 100, with higher scores indicating greater patient activation (better outcome).</description>
        <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HARP Intervention</title>
            <description>HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention: Control</title>
            <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</description>
          </group>
        </group_list>
        <measure>
          <title>Behavioral Activation</title>
          <description>Behavioral Activation was measured using the Patient Activation Measure (PAM), an instrument which has been found to be reliable and valid across a wide range of patient populations. The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. Possible scores range from 0 to 100, with higher scores indicating greater patient activation (better outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.4" spread="16.6"/>
                    <measurement group_id="O2" value="55.7" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.6" spread="15.9"/>
                    <measurement group_id="O2" value="56.4" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.5" spread="16.7"/>
                    <measurement group_id="O2" value="57.2" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dietary Intake</title>
        <description>Dietary intake was assessed with the Block Fat-Sugar-Fruit-Vegetable Screener, which is a validated 55-item scale assessing both frequency and quantity of food intake based on typical eating habits. Possible scores range from 0 to 68, with higher scores indicating greater consumption of fat (worse outcome).</description>
        <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HARP Intervention</title>
            <description>HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention: Control</title>
            <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</description>
          </group>
        </group_list>
        <measure>
          <title>Dietary Intake</title>
          <description>Dietary intake was assessed with the Block Fat-Sugar-Fruit-Vegetable Screener, which is a validated 55-item scale assessing both frequency and quantity of food intake based on typical eating habits. Possible scores range from 0 to 68, with higher scores indicating greater consumption of fat (worse outcome).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="5.1"/>
                    <measurement group_id="O2" value="9.8" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="5.0"/>
                    <measurement group_id="O2" value="9.3" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="5.6"/>
                    <measurement group_id="O2" value="9.4" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Adherence</title>
        <description>Medication Adherence was assessed using the Morisky scale, a 4-item questionnaire that has been shown to have strong content and predictive validity in hypertension,cardiovascular disease,and diabetes. Possible scores range from 0 to 4 with lower scores indicating greater medication adherence.</description>
        <time_frame>Baseline, 3 months post-intervention, 6 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HARP Intervention</title>
            <description>HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
          </group>
          <group group_id="O2">
            <title>No Intervention: Control</title>
            <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Adherence</title>
          <description>Medication Adherence was assessed using the Morisky scale, a 4-item questionnaire that has been shown to have strong content and predictive validity in hypertension,cardiovascular disease,and diabetes. Possible scores range from 0 to 4 with lower scores indicating greater medication adherence.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="0.94"/>
                    <measurement group_id="O2" value="0.94" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="0.92"/>
                    <measurement group_id="O2" value="0.97" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.84" spread="0.92"/>
                    <measurement group_id="O2" value="0.89" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months post-intervention, 6 months post-intervention</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HARP Intervention</title>
          <description>HARP Intervention: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.</description>
        </group>
        <group group_id="E2">
          <title>No Intervention: Control</title>
          <description>Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="202"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="202"/>
              </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="198"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="202"/>
              </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. Benjamin Druss</name_or_title>
      <organization>Emory University</organization>
      <phone>404-712-9602</phone>
      <email>bdruss@emory.edu</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/NCT01725815
org study id: IRB00047631a
secondary id: 1R01MH090584-01A1
nct id: NCT01725815
lead sponsor: 
collaborator: 
has dmc: Yes
Individuals with serious mental illnesses (SMI) face high rates of medical comorbidity as
      well as challenges in managing these conditions. A growing workforce of certified peer
      specialists is available to help these individuals more effectively manage their health and
      health care. However, there is little existing research examining the effectiveness of
      peer-led medical self-management programs for this population. in this trial, participants
      were randomized to either the Health and Recovery Peer program (HARP), a medical disease
      self-management program led by certified peer specialists, or to care as usual. Assessments
      were conducted at baseline, 3 months, and 6 months.
Persons with serious mental illnesses (SMI) face elevated rates of medical comorbidity, and
      also challenges in effectively managing these health problems. There is an urgent need to
      develop self-management strategies that allow persons with SMI to more effectively manage
      their chronic medical illnesses.

      In general populations, peer-led disease self-management interventions have been demonstrated
      to be feasible, effective, scalable, and to lead to sustainable improvements in
      self-management and health outcomes. With funding from an R34 intervention development grant
      from NIMH, the study team has developed and piloted a modified version of the most widely
      tested and used peer-led self management program, the Chronic Disease Self-Management Program
      (CDSMP), for persons with serious mental illness. Two pilot tests of this intervention, the
      Health and Recovery Peer (HARP) program, demonstrated that the program can be implemented
      with high engagement, retention, and program fidelity, and can result in effect sizes across
      a range of outcomes comparable to or greater than those seen in general medical populations.

      This application proposes to conduct a fully-powered, multisite trial of the HARP program. A
      total of 400 individuals with serious mental illnesses and one or more chronic medical
      condition will be recruited from three diverse community mental health clinics in the Atlanta
      metro region and randomized to the HARP program or usual care. For individuals in the HARP
      program, two peer educators with SMI and one or more chronic medical condition will lead a
      six-session, six-week manualized intervention, which helps participants become more effective
      managers of their chronic illnesses. Follow-up interviews and chart reviews at 3 months, 6
      months and one year will assess changes in clinical outcomes, improvement in generic and
      disease-specific measures of illness self-management, and quality of care. During the final
      phase of the study, a dissemination strategy building on the CDSMP training infrastructure
      will allow program participants to lead HARP groups.

      This study will establish the first fully peer-led, evidence-based intervention for improving
      physical self-management in this vulnerable population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Health Related Quality of Life (HRQOL)
time frame: Baseline, 3 months post-intervention, 6 months post-intervention
description: The short form-36-item (SF-36) Physical component score (PCS) is a measure of HRQOL constructed for use in the Medical Outcomes Study that rely upon patient self-reporting and reflects the physical functioning. The scores ranges from 0-100 with higher scores indicating greater levels of physical functioning.
measure: Behavioral Activation
time frame: Baseline, 3 months post-intervention, 6 months post-intervention
description: Behavioral Activation was measured using the Patient Activation Measure (PAM), an instrument which has been found to be reliable and valid across a wide range of patient populations. The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. Possible scores range from 0 to 100, with higher scores indicating greater patient activation (better outcome).
measure: Dietary Intake
time frame: Baseline, 3 months post-intervention, 6 months post-intervention
description: Dietary intake was assessed with the Block Fat-Sugar-Fruit-Vegetable Screener, which is a validated 55-item scale assessing both frequency and quantity of food intake based on typical eating habits. Possible scores range from 0 to 68, with higher scores indicating greater consumption of fat (worse outcome).
measure: Medication Adherence
time frame: Baseline, 3 months post-intervention, 6 months post-intervention
description: Medication Adherence was assessed using the Morisky scale, a 4-item questionnaire that has been shown to have strong content and predictive validity in hypertension,cardiovascular disease,and diabetes. Possible scores range from 0 to 4 with lower scores indicating greater medication adherence.
arm group label: HARP Intervention
arm group type: Experimental
arm group label: No Intervention: Control
arm group type: No Intervention
description: Participants in usual care will continue to obtain any mental health or peer-support services that they would otherwise be receiving.
intervention type: Behavioral
intervention name: HARP Intervention
description: The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
arm group label: HARP Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Druss, MD, MPH
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Benjamin Druss
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Hyperlipidemias
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 