<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/NCT03246035</url>
  </required_header>
  <id_info>
    <org_study_id>ADHF-ED-JGH</org_study_id>
    <nct_id>NCT03246035</nct_id>
  </id_info>
  <brief_title>Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure</brief_title>
  <acronym>HFF-ED</acronym>
  <official_title>A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Association of Emergency Physicians</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jewish General Hospital</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>
      A randomized study designed to determine whether telephone based interventions can prevent&#xD;
      return hospital visits for elderly and frail patients with acute symptoms of heart failure.&#xD;
      Specifically, the intervention will improve patients ability to monitor and address self care&#xD;
      of heart failure at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute decompensated heart failure (ADHF) is a common illness in Canadian emergency&#xD;
      departments (ED). The frail subset of elderly patients with ADHF is challenging to treat, use&#xD;
      a large proportion of available resources, and are at higher risk for complications,&#xD;
      including readmission to hospital after discharge. The investigators believe that by&#xD;
      improving access to follow-up, optimizing self-care, and addressing the various cognitive and&#xD;
      physical limitations of frailty, it will be possible to improve quality of life and reduce&#xD;
      readmission rates for frail patients with ADHF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</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>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause death, hospital readmission, or ED revisit</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of return visits to any ER for any medical issue</measure>
    <time_frame>30 days</time_frame>
    <description>Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of admission to hospital at 90 days</measure>
    <time_frame>90 days</time_frame>
    <description>Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse effects from medication</measure>
    <time_frame>90 days</time_frame>
    <description>Number of patients who experience unexpected side effects from their heart failure medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Care Index</measure>
    <time_frame>90 days</time_frame>
    <description>Change in the Self-Care Heart Failure Index from enrollment to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Failure Symptom Scale</measure>
    <time_frame>90 days</time_frame>
    <description>Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frailty Index</measure>
    <time_frame>90 days</time_frame>
    <description>Change in the Frailty Index from enrollment to follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>90 days</time_frame>
    <description>The number of eligible of patients recruited into the study over a 3 month trial period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition rate</measure>
    <time_frame>90 days</time_frame>
    <description>The number of patients enrolled the study who choose to leave the study before completing the follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Informed consent validation (qualitative)</measure>
    <time_frame>90 days</time_frame>
    <description>Qualitative feedback from participants regarding the informed consent process</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death, hospital readmission, or ED revisit</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Heart Failure</condition>
  <condition>Acute Decompensated Heart Failure</condition>
  <condition>Fragility</condition>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>Control Group (Standard Care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Group</intervention_name>
    <description>For the intervention arm, a specialized heart failure nurse practitioner will contact the patient or their primary caregiver by telephone within 5 days post-discharge and send them an education packet by mail. During the telephone call, the nurse will (1) confirm the patient's scheduled follow-up appointment in cardiology, (2) provide recommendations for heart failure self-care behaviors that were found to be deficient at baseline. Patients will then be referred to a Geriatrics Assessment Team, who will provide individualized recommendations for frailty domains that were found to be deficient at baseline. The technique used to provide educational recommendations will be motivational interviewing.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group (Standard Care)</intervention_name>
    <description>For patients randomized to the Control Group (Standard Care), they will receive their follow-up visits, medications, diet and physical activity advice as they normally would. This is the care they would receive even if they were not enrolled in the study</description>
    <arm_group_label>Control Group (Standard Care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who presented to the ED and who are being discharged with a primary or&#xD;
             secondary diagnosis of ADHF&#xD;
&#xD;
          -  Age ≥ 65&#xD;
&#xD;
          -  Frailty, defined as a FRAIL score &gt;=3/5 or Clinical Frailty Scale (CFS) score &gt;=5/9&#xD;
&#xD;
          -  Informed consent provided by the patient or proxy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant dementia or active delirium&#xD;
&#xD;
          -  Severe frailty, defined as a CFS score &gt;=8/9&#xD;
&#xD;
          -  Prohibitive language barrier&#xD;
&#xD;
          -  Primary address outside of Quebec&#xD;
&#xD;
          -  Patient deemed to be palliative or moribund by treating team&#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>Jonathan Afilalo, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Jonathan Afilalo</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Acute Decompensated Heart Failure</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Frailty</keyword>
  <keyword>Geriatrics</keyword>
  <keyword>Self-care</keyword>
  <keyword>Emergency Medicine</keyword>
  <keyword>Cardiology</keyword>
  <keyword>Patient Oriented Research</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>CODIM-MBM-17-052</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.ladydavis.ca/en/jonathanafilalo</doc_url>
      <doc_comment>Pilot study protocol</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>CODIM-MBM-17-052</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>http://www.ladydavis.ca/en/jonathanafilalo</doc_url>
      <doc_comment>Patient consent Caregiver consent French and English available</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03246035
org study id: ADHF-ED-JGH
nct id: NCT03246035
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized study designed to determine whether telephone based interventions can prevent
      return hospital visits for elderly and frail patients with acute symptoms of heart failure.
      Specifically, the intervention will improve patients ability to monitor and address self care
      of heart failure at home.
Acute decompensated heart failure (ADHF) is a common illness in Canadian emergency
      departments (ED). The frail subset of elderly patients with ADHF is challenging to treat, use
      a large proportion of available resources, and are at higher risk for complications,
      including readmission to hospital after discharge. The investigators believe that by
      improving access to follow-up, optimizing self-care, and addressing the various cognitive and
      physical limitations of frailty, it will be possible to improve quality of life and reduce
      readmission rates for frail patients with ADHF.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: All-cause death, hospital readmission, or ED revisit
time frame: 90 days
measure: Rate of return visits to any ER for any medical issue
time frame: 30 days
description: Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period.
measure: Rate of admission to hospital at 90 days
time frame: 90 days
description: Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.
measure: Incidence of adverse effects from medication
time frame: 90 days
description: Number of patients who experience unexpected side effects from their heart failure medications
measure: Self-Care Index
time frame: 90 days
description: Change in the Self-Care Heart Failure Index from enrollment to follow-up
measure: Heart Failure Symptom Scale
time frame: 90 days
description: Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up
measure: Frailty Index
time frame: 90 days
description: Change in the Frailty Index from enrollment to follow-up
measure: Recruitment rate
time frame: 90 days
description: The number of eligible of patients recruited into the study over a 3 month trial period
measure: Attrition rate
time frame: 90 days
description: The number of patients enrolled the study who choose to leave the study before completing the follow-up
measure: Informed consent validation (qualitative)
time frame: 90 days
description: Qualitative feedback from participants regarding the informed consent process
measure: All-cause death, hospital readmission, or ED revisit
time frame: 1 year
arm group label: Control Group (Standard Care)
arm group type: Active Comparator
description: The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital.
arm group label: Intervention Group
arm group type: Experimental
description: The intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline.
intervention type: Behavioral
intervention name: Intervention Group
description: For the intervention arm, a specialized heart failure nurse practitioner will contact the patient or their primary caregiver by telephone within 5 days post-discharge and send them an education packet by mail. During the telephone call, the nurse will (1) confirm the patient's scheduled follow-up appointment in cardiology, (2) provide recommendations for heart failure self-care behaviors that were found to be deficient at baseline. Patients will then be referred to a Geriatrics Assessment Team, who will provide individualized recommendations for frailty domains that were found to be deficient at baseline. The technique used to provide educational recommendations will be motivational interviewing.
arm group label: Intervention Group
intervention type: Other
intervention name: Control Group (Standard Care)
description: For patients randomized to the Control Group (Standard Care), they will receive their follow-up visits, medications, diet and physical activity advice as they normally would. This is the care they would receive even if they were not enrolled in the study
arm group label: Control Group (Standard Care)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan Afilalo, FRCPC
role: Principal Investigator
affiliation: Associate Professor
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Jewish General Hospital
investigator full name: Jonathan Afilalo
investigator title: Researcher
mesh term: Heart Failure
mesh term: Emergencies
sharing ipd: No
study doc: 
study doc: 