<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/NCT01669395</url>
  </required_header>
  <id_info>
    <org_study_id>H-2-2012-021</org_study_id>
    <nct_id>NCT01669395</nct_id>
  </id_info>
  <brief_title>Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial</brief_title>
  <official_title>Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of an early, coordinated&#xD;
      rehabilitation intervention for patients with severe heart failure in NYHA class III and IV&#xD;
      with a ejection fraction of &lt;40% of normal cardiac function measured on frequency of&#xD;
      readmissions, physical ability and participation in activities of daily living and quality of&#xD;
      life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 400,000 Danes live today with heart disease. Disease severity is crucial for&#xD;
      patients quality of life. Patients with severe heart disease often struggle with everyday&#xD;
      life, characterized by reduced physical capacity, tendency to depression and anxiety to&#xD;
      perform everyday activities that may provoke symptoms.&#xD;
&#xD;
      A large proportion of patients who are offered cardiac rehabilitation deselect that offer. Of&#xD;
      the patients who do participate, more than 50% stop the rehabilitation ahead of time. A large&#xD;
      group of patients with severe heart failure and classified in NYHA Class III and IV, deselect&#xD;
      the offer because of lack of energy to participate in cardiac rehabilitation or is when&#xD;
      specified by a medical assessment discharged from the hospital without the offer of training&#xD;
      or any other form of rehabilitation.&#xD;
&#xD;
      The offer of rehabilitation for patients with severe heart failure is lacking as it is today.&#xD;
      This study assesses the effectiveness of an early home based rehabilitation program that&#xD;
      complements the general psycho-social support, symptom-oriented and preventive medical&#xD;
      treatment that these patients always have the option to get.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">September 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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission due to heart failure</measure>
    <time_frame>assessed one year after inclusion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical capacity</measure>
    <time_frame>Assessed at baseline, after 6 weeks, after 6 month and after one year</time_frame>
    <description>measured by the Morton Mobility Index, Timed Up &amp; Go and Modified Sit to Stand Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity of Daily Living</measure>
    <time_frame>Assessed at baseline, after 6 weeks, after 6 month and after one year</time_frame>
    <description>Recorded at an ADL interview to assess the performance of everyday activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of total hospital admissions</measure>
    <time_frame>at baseline, after 6 weeks, after 6 month and after one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Compliance</measure>
    <time_frame>at baseline, after 6 weeks, after 6 month and after one year</time_frame>
    <description>registration of exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>at baseline, after 6 weeks, after 6 month and after one year</time_frame>
    <description>measured by Hospital Anxiety and Depression Scale (HAD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>at baseline, after 6 weeks, after 6 month and after one year</time_frame>
    <description>measured by The Minnesota Living with Heart Failure Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)</measure>
    <time_frame>at 6 weeks, after 6 month and after one year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Chronic Heart Failure</condition>
  <condition>Heart Failure NYHA Class II</condition>
  <condition>Heart Failure NYHA Class III</condition>
  <condition>Heart Failure NYHA Class IV</condition>
  <arm_group>
    <arm_group_label>Early homebased rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group: Ususal care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early homebased rehabilitation after hospital admission</intervention_name>
    <description>Training begins 3-5 days after discharge from hospital, performed by an occupational therapist and a physiotherapist from Gentofte Hospital in the first two weeks. From week three to six the training will be carried out by an occupational therapist and a physiotherapist from the local municipality (Gentofte municipality and Lyngby Taarbæk municipality). Training will take place at home twice a week for 6 weeks, each session lasting 45 minutes. The intervention is individualized and focuses on functional physical and compensatory training to help the patient to manage everyday life at home. A training program will be provided and the patient will be instructed to do the exercises every day</description>
    <arm_group_label>Early homebased rehabilitation</arm_group_label>
    <other_name>severe heart failure</other_name>
    <other_name>homebased rehabilitation</other_name>
    <other_name>physical exercise</other_name>
    <other_name>activities of daily living</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support</description>
    <arm_group_label>control group: Ususal care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the Gentofte Hospital due to heart failure.&#xD;
&#xD;
          -  Patients with a functional equivalent to NYHA grade III or IV&#xD;
&#xD;
          -  Patients with ejection fraction &lt;40%&#xD;
&#xD;
          -  Patients who score between10-15 in the total score for question 3 dealing with&#xD;
             physical functioning in SF-36 questionnaire on health status&#xD;
&#xD;
          -  Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality.&#xD;
&#xD;
          -  Patients who can speak and understand Danish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cognitive and psychological problems that prevents cooperation (aphasia,&#xD;
             dementia, severe depression).&#xD;
&#xD;
          -  Patients with terminal illness with expected death within a year.&#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_contact>
    <last_name>Laura Staun Valentiner, Master in health scien</last_name>
    <phone>+ 45 39 77 39 51</phone>
    <email>laura.risted.staun.valentiner@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carsten Juhl, Ph.D.stud</last_name>
    <phone>+ 45 39 77 39 51</phone>
    <email>carsten.juhl@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,</name>
      <address>
        <city>Copenhagen</city>
        <state>Gentofte</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <contact>
      <last_name>Laura Staun Valentiner, masters in health sciences</last_name>
      <phone>+ 45 39 77 39 51</phone>
      <email>laura.risted.staun.valentiner@regionh.dk</email>
    </contact>
    <contact_backup>
      <last_name>Carsten Juhl, Ph.D stud.</last_name>
      <phone>+ 45 39 77 39 51</phone>
      <email>carsten.juhl@regionh.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Laura Staun Valentiner, Masters in Health Science</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>August 16, 2012</last_update_submitted>
  <last_update_submitted_qc>August 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Laura Staun Valentiner</investigator_full_name>
    <investigator_title>Research and Development Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Severe heart failure</keyword>
  <keyword>Homebased rehabilitation</keyword>
  <keyword>Physical exercise</keyword>
  <keyword>Activities of daily living</keyword>
  <keyword>Intersectoral Cooperation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT01669395
org study id: H-2-2012-021
nct id: NCT01669395
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effect of an early, coordinated
      rehabilitation intervention for patients with severe heart failure in NYHA class III and IV
      with a ejection fraction of <40% of normal cardiac function measured on frequency of
      readmissions, physical ability and participation in activities of daily living and quality of
      life.
Approximately 400,000 Danes live today with heart disease. Disease severity is crucial for
      patients quality of life. Patients with severe heart disease often struggle with everyday
      life, characterized by reduced physical capacity, tendency to depression and anxiety to
      perform everyday activities that may provoke symptoms.

      A large proportion of patients who are offered cardiac rehabilitation deselect that offer. Of
      the patients who do participate, more than 50% stop the rehabilitation ahead of time. A large
      group of patients with severe heart failure and classified in NYHA Class III and IV, deselect
      the offer because of lack of energy to participate in cardiac rehabilitation or is when
      specified by a medical assessment discharged from the hospital without the offer of training
      or any other form of rehabilitation.

      The offer of rehabilitation for patients with severe heart failure is lacking as it is today.
      This study assesses the effectiveness of an early home based rehabilitation program that
      complements the general psycho-social support, symptom-oriented and preventive medical
      treatment that these patients always have the option to get.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Readmission due to heart failure
time frame: assessed one year after inclusion
measure: Physical capacity
time frame: Assessed at baseline, after 6 weeks, after 6 month and after one year
description: measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test
measure: Activity of Daily Living
time frame: Assessed at baseline, after 6 weeks, after 6 month and after one year
description: Recorded at an ADL interview to assess the performance of everyday activities
measure: Number of total hospital admissions
time frame: at baseline, after 6 weeks, after 6 month and after one year
measure: Exercise Compliance
time frame: at baseline, after 6 weeks, after 6 month and after one year
description: registration of exercise
measure: Anxiety and depression
time frame: at baseline, after 6 weeks, after 6 month and after one year
description: measured by Hospital Anxiety and Depression Scale (HAD)
measure: Quality of life
time frame: at baseline, after 6 weeks, after 6 month and after one year
description: measured by The Minnesota Living with Heart Failure Questionnaire
measure: Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)
time frame: at 6 weeks, after 6 month and after one year
arm group label: Early homebased rehabilitation
arm group type: Experimental
description: After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
arm group label: control group: Ususal care
arm group type: Experimental
description: After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
intervention type: Other
intervention name: Early homebased rehabilitation after hospital admission
description: Training begins 3-5 days after discharge from hospital, performed by an occupational therapist and a physiotherapist from Gentofte Hospital in the first two weeks. From week three to six the training will be carried out by an occupational therapist and a physiotherapist from the local municipality (Gentofte municipality and Lyngby Taarbæk municipality). Training will take place at home twice a week for 6 weeks, each session lasting 45 minutes. The intervention is individualized and focuses on functional physical and compensatory training to help the patient to manage everyday life at home. A training program will be provided and the patient will be instructed to do the exercises every day
arm group label: Early homebased rehabilitation
other name: severe heart failure
other name: homebased rehabilitation
other name: physical exercise
other name: activities of daily living
intervention type: Other
intervention name: Usual care
description: After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
arm group label: control group: Ususal care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laura Staun Valentiner, Master in health scien
phone: + 45 39 77 39 51
email: laura.risted.staun.valentiner@regionh.dk
last name: Carsten Juhl, Ph.D.stud
phone: + 45 39 77 39 51
email: carsten.juhl@regionh.dk
facility: 
contact: 
contact backup: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Laura Staun Valentiner
investigator title: Research and Development Physiotherapist
mesh term: Heart Failure