<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/NCT04507529</url>
  </required_header>
  <id_info>
    <org_study_id>Alias: 200348</org_study_id>
    <nct_id>NCT04507529</nct_id>
  </id_info>
  <brief_title>Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients</brief_title>
  <official_title>'HjertensGlad'.Inequality in Cardiac Rehabilitation Attendance: Peer-mentors as a Feasible Solution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Velux Fonden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Nurses Organisation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nordsjællands Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an&#xD;
      increasingly older myocardial infarction (MI) population in need of cardiac rehabilitation&#xD;
      (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established;&#xD;
      CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life&#xD;
      among patients with ischemic heart disease. These positive effects of CR has also been&#xD;
      established among older patients. The inherent problem lies in the low attendance rate, often&#xD;
      below 50%. Several studies, including studies from Denmark, have shown that low participation&#xD;
      in CR is most prevalent among older, vulnerable female patients. The notion vulnerable covers&#xD;
      patients with low socioeconomic position (SEP), patients with non-western background and&#xD;
      patients living alone, as these groups have particularly low CR attendance. Effective&#xD;
      interventions aiming at increasing CR attendance among these low attending groups are thus&#xD;
      warranted and the current study will seek to address this.&#xD;
&#xD;
      AIM: To test feasibility and acceptability of methods used in a peer-mentor intervention&#xD;
      among older female and vulnerable post MI patients.&#xD;
&#xD;
      DESIGN AND METHODS: The study is designed as a one arm feasibility study. Patients (n=20) are&#xD;
      recruited by a dedicated research nurse before discharge from the cardiology department at&#xD;
      Nordsjællands Hospital. Data is collected at three timepoints, baseline, 12 weeks and 24&#xD;
      weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring&#xD;
      by a person with a similar life situation or health problem as one self) is a low-cost&#xD;
      intervention that holds the potential to improve CR attendance and improve physical and&#xD;
      psychological outcomes among older patients. Peer-mentors are role models who can guide and&#xD;
      support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR&#xD;
      setting among older, female and vulnerable MI patients; establishing the novelty of the&#xD;
      current study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2020</start_date>
  <completion_date type="Actual">June 21, 2021</completion_date>
  <primary_completion_date type="Actual">June 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of patients included from eligible patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dropout</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of patients not completing the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>Semi-structured qualitative interviews with patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of contacts</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of contacts between patient and peer-mentor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Content of contacts</measure>
    <time_frame>24 weeks</time_frame>
    <description>Content of contacts between patient and peer-mentor will be assessed through open ended question on questionnaire i.e. 'What was the content of your meeting? e.g face-to-face meeting with conversation about everyday life'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CR attendance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured as 'self-reported CR attendance'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CR attendance</measure>
    <time_frame>24 weeks</time_frame>
    <description>Measured as 'self-reported CR attendance'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Health-related Quality of Life</measure>
    <time_frame>Baseline to 24 weeks</time_frame>
    <description>Measured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'. Min. score: 0, max score: 42. Higher scores indicating a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Self-efficacy</measure>
    <time_frame>Baseline to 24 weeks</time_frame>
    <description>Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in symptoms of anxiety and depression</measure>
    <time_frame>Baseline to 24 weeks</time_frame>
    <description>Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dietary quality</measure>
    <time_frame>Baseline to 24 weeks</time_frame>
    <description>Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>Baseline to 24 weeks</time_frame>
    <description>Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Peer-mentoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peer-mentoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peer-mentoring</intervention_name>
    <description>Patients (mentees) are matched with a peer-mentor. Throughout the intervention period (24 weeks), the mentee and the mentor will have informal telephone contact and meet face-to face approximately 8 times during the intervention period.</description>
    <arm_group_label>Peer-mentoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥65 years and diagnosed with MI and referred to CR and female or low SEP or single&#xD;
             living or non-western background.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to provide written consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria K Pedersen, Ph.d.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nordsjællands Hospital - Frederikssund</name>
      <address>
        <city>Frederikssund</city>
        <zip>3600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordsjællands Hospital - Hillerød</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College Copenhagen</investigator_affiliation>
    <investigator_full_name>Maria Kjøller Pedersen</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04507529
org study id: Alias: 200348
nct id: NCT04507529
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an
      increasingly older myocardial infarction (MI) population in need of cardiac rehabilitation
      (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established;
      CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life
      among patients with ischemic heart disease. These positive effects of CR has also been
      established among older patients. The inherent problem lies in the low attendance rate, often
      below 50%. Several studies, including studies from Denmark, have shown that low participation
      in CR is most prevalent among older, vulnerable female patients. The notion vulnerable covers
      patients with low socioeconomic position (SEP), patients with non-western background and
      patients living alone, as these groups have particularly low CR attendance. Effective
      interventions aiming at increasing CR attendance among these low attending groups are thus
      warranted and the current study will seek to address this.

      AIM: To test feasibility and acceptability of methods used in a peer-mentor intervention
      among older female and vulnerable post MI patients.

      DESIGN AND METHODS: The study is designed as a one arm feasibility study. Patients (n=20) are
      recruited by a dedicated research nurse before discharge from the cardiology department at
      Nordsjællands Hospital. Data is collected at three timepoints, baseline, 12 weeks and 24
      weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring
      by a person with a similar life situation or health problem as one self) is a low-cost
      intervention that holds the potential to improve CR attendance and improve physical and
      psychological outcomes among older patients. Peer-mentors are role models who can guide and
      support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR
      setting among older, female and vulnerable MI patients; establishing the novelty of the
      current study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Recruitment
time frame: Baseline
description: Number of patients included from eligible patients
measure: Dropout
time frame: 24 weeks
description: Number of patients not completing the intervention
measure: Satisfaction with intervention
time frame: 12 weeks
description: Semi-structured qualitative interviews with patients
measure: Number of contacts
time frame: 24 weeks
description: Number of contacts between patient and peer-mentor
measure: Content of contacts
time frame: 24 weeks
description: Content of contacts between patient and peer-mentor will be assessed through open ended question on questionnaire i.e. 'What was the content of your meeting? e.g face-to-face meeting with conversation about everyday life'
measure: CR attendance
time frame: 12 weeks
description: Measured as 'self-reported CR attendance'
measure: CR attendance
time frame: 24 weeks
description: Measured as 'self-reported CR attendance'
measure: Change in Health-related Quality of Life
time frame: Baseline to 24 weeks
description: Measured using the 'HeartQoL' 'Health-related Quality of Life Questionnaire'. Min. score: 0, max score: 42. Higher scores indicating a better outcome.
measure: Change in Self-efficacy
time frame: Baseline to 24 weeks
description: Measured using the questionnaire 'General self-efficacy scale'. Min score: 10, max score: 40. Higher scores indicating a better outcome
measure: Change in symptoms of anxiety and depression
time frame: Baseline to 24 weeks
description: Measured using the questionnaire 'The hospital anxiety and depression scale' (HADS). Min. score: 0, max score 42. Lower scores indicating a better outcome
measure: Change in dietary quality
time frame: Baseline to 24 weeks
description: Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
measure: Change in physical activity
time frame: Baseline to 24 weeks
description: Measured using the questionnaire 'Heartdiet'. Higher scores indicating a better outcome
arm group label: Peer-mentoring
arm group type: Experimental
description: Peer-mentoring
intervention type: Other
intervention name: Peer-mentoring
description: Patients (mentees) are matched with a peer-mentor. Throughout the intervention period (24 weeks), the mentee and the mentor will have informal telephone contact and meet face-to face approximately 8 times during the intervention period.
arm group label: Peer-mentoring
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Maria K Pedersen, Ph.d.
role: Principal Investigator
affiliation: University College Copenhagen
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University College Copenhagen
investigator full name: Maria Kjøller Pedersen
investigator title: Assistant Professor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No