<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/NCT01668394</url>
  </required_header>
  <id_info>
    <org_study_id>Ethics app. number: 20100230</org_study_id>
    <nct_id>NCT01668394</nct_id>
  </id_info>
  <brief_title>Effect of Learning and Coping Strategies in Cardiac Rehabilitation - Group Study</brief_title>
  <acronym>LC-REHAB</acronym>
  <official_title>Effect of Learning and Coping Strategies in Cardiac Rehabilitation - A Randomised Controlled Parallel Group Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herning Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herning Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: It is well known that cardiac rehabilitation has potential to reduce morbidity&#xD;
      and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the&#xD;
      effect of a new patient education method called learning and coping strategies to that of&#xD;
      standard care.&#xD;
&#xD;
      Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly&#xD;
      hospitalised with either ischaemic heart disease or heart failure.&#xD;
&#xD;
      Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation&#xD;
      with addition of learning and coping strategies which include participation of experienced&#xD;
      patients as co-educators, clarifuing interviews, and inductive teaching style.&#xD;
&#xD;
      Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.&#xD;
&#xD;
      Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle,&#xD;
      health related quality of life, return to work.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary heart disease is one the most common cause of death in Denmark and is also a chronic&#xD;
      disease that 300,000 people in the country are living with. Cardiac rehabilitation is of&#xD;
      great significance for this group of people because of its potential to reduce mortality and&#xD;
      morbidity. However, not all patients succeed in changing their lifestyle in a positive and&#xD;
      heart healthy direction. Thus, it is a great challenge to develop new methods which can help&#xD;
      the patients to maintain a more healthy lifestyle in the long run. A concept for patient&#xD;
      education, called learning and coping, has been developed in Norway. It is a health education&#xD;
      method based on a high degree of involvement from the participants and on what is important&#xD;
      for them. Planning, performance and evaluation happens in close cooperation between the&#xD;
      health staff and so-called experienced patients. The course begins and ends with individual&#xD;
      clarifying interviews.&#xD;
&#xD;
      The aim of this study is to evaluate the effect of learning and coping strategies in cardiac&#xD;
      rehabilitation on adherence, risk factors and lifestyle, morbidity and mortality, health&#xD;
      related quality of life and return to work.&#xD;
&#xD;
      The number of participants needed are estimated to 750 ptt.s with datacollection at baseline,&#xD;
      just after rehabilitation, 3 months after rehabilitation and 3 years after rehabilitation. It&#xD;
      is carried out as an open randomised controlled parallel group study in three hospitals in&#xD;
      Hospital Unit West Jutland, Central Denmark Region, where the participants newly hospitalised&#xD;
      with either ischemic heart disease or heart failure is randomised to either the intervention&#xD;
      group with learning and coping strategies or to the standard group without the strategies.&#xD;
      The rehabilitation courses in both groups last for eight weeks and consist of both training&#xD;
      and education sessions. The concept of learning and coping is applied to the intervention&#xD;
      group by letting 'experienced patients' participate in the education and not using&#xD;
      standardised teaching slides. Also clarifying individual interviews are completed before and&#xD;
      after the course. The 1:1 randomisation is computer generated and is stratified by hospital&#xD;
      unit, diagnosis and gender. All analyses will be performed after the principle of 'intention&#xD;
      to treat'.&#xD;
&#xD;
      The primary outcomes are adherence to cardiac rehabilitation, morbidity and mortality, while&#xD;
      secondary outcomes are risk factors (blood pressure and lipid profile), lifestyle (body mass&#xD;
      index, waist circumference, smoking status, exercise capacity and body compositions measured&#xD;
      via DXA-scans) and health related quality of life (SF-12, Health Education Impact&#xD;
      Questionnaire and Major Depression Inventory) and return to work (derived from the Danish&#xD;
      Register for Evaluation of Marginalisation, (DREAM))&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2010</start_date>
  <completion_date type="Actual">March 8, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to cardiac rehabilitation</measure>
    <time_frame>After 8 weeks of cardiac rehabilitation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity and mortality</measure>
    <time_frame>Three or four years after last patient into trial</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk- and lifestyle factors</measure>
    <time_frame>At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related Quality of life</measure>
    <time_frame>At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>at baseline and after one year</time_frame>
    <description>Four weeks of self support at follow up derived from the Danish Register for Evaluation of Marginalisation (DREAM)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">825</enrollment>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Learning and coping arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual care. Teaching style: deductive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Learning and coping arm</intervention_name>
    <description>Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.</description>
    <arm_group_label>Learning and coping arm</arm_group_label>
    <other_name>Learning and coping strategies in cardiac rehabilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control arm</intervention_name>
    <description>Usual care. Teaching style: deductive.</description>
    <arm_group_label>Control arm</arm_group_label>
    <other_name>Standard cardiac rehabilitation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients above 18 years hospitalised with ichemic heart disease or heart failure&#xD;
             motivated for completing a rehabilitation course&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute coronary syndrome less than five days before randomisation,&#xD;
&#xD;
          -  active peri-, myo- or endocarditis,&#xD;
&#xD;
          -  untreated symptomatic valvular disease,&#xD;
&#xD;
          -  hypertension with systolic pressure over 200 mmHg and/or diastolic pressure over 110&#xD;
             mmHg,&#xD;
&#xD;
          -  other extracardiac disease,&#xD;
&#xD;
          -  planned revascularization,&#xD;
&#xD;
          -  senile dementia,&#xD;
&#xD;
          -  known compliance and former participation in the study.&#xD;
&#xD;
        Exclusion Criteria for outcome on return to work:&#xD;
&#xD;
          -  age above 60 years&#xD;
&#xD;
          -  recieving public transfer payments related to permanent work incapacity at week of&#xD;
             inclusion.&#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>Vibeke Lynggaard, MHsc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regional Hospital West Jutland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Hospital West Jutland</name>
      <address>
        <city>Herning</city>
        <state>Central Denmark Region</state>
        <zip>7400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/25495543</url>
    <description>BMC Cardiovascular Disorders</description>
  </link>
  <reference>
    <citation>Lynggaard V, May O, Beauchamp A, Nielsen CV, Wittrup I. LC-REHAB: randomised trial assessing the effect of a new patient education method--learning and coping strategies--in cardiac rehabilitation. BMC Cardiovasc Disord. 2014 Dec 13;14:186. doi: 10.1186/1471-2261-14-186.</citation>
    <PMID>25495543</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>March 9, 2018</last_update_submitted>
  <last_update_submitted_qc>March 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herning Hospital</investigator_affiliation>
    <investigator_full_name>Vibeke Lynggaard</investigator_full_name>
    <investigator_title>MHsc, PhD student at Cardiovasculat Research Unit</investigator_title>
  </responsible_party>
  <!-- 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/NCT01668394
org study id: Ethics app. number: 20100230
nct id: NCT01668394
lead sponsor: 
has dmc: No
Background: It is well known that cardiac rehabilitation has potential to reduce morbidity
      and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the
      effect of a new patient education method called learning and coping strategies to that of
      standard care.

      Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly
      hospitalised with either ischaemic heart disease or heart failure.

      Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation
      with addition of learning and coping strategies which include participation of experienced
      patients as co-educators, clarifuing interviews, and inductive teaching style.

      Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.

      Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle,
      health related quality of life, return to work.
Coronary heart disease is one the most common cause of death in Denmark and is also a chronic
      disease that 300,000 people in the country are living with. Cardiac rehabilitation is of
      great significance for this group of people because of its potential to reduce mortality and
      morbidity. However, not all patients succeed in changing their lifestyle in a positive and
      heart healthy direction. Thus, it is a great challenge to develop new methods which can help
      the patients to maintain a more healthy lifestyle in the long run. A concept for patient
      education, called learning and coping, has been developed in Norway. It is a health education
      method based on a high degree of involvement from the participants and on what is important
      for them. Planning, performance and evaluation happens in close cooperation between the
      health staff and so-called experienced patients. The course begins and ends with individual
      clarifying interviews.

      The aim of this study is to evaluate the effect of learning and coping strategies in cardiac
      rehabilitation on adherence, risk factors and lifestyle, morbidity and mortality, health
      related quality of life and return to work.

      The number of participants needed are estimated to 750 ptt.s with datacollection at baseline,
      just after rehabilitation, 3 months after rehabilitation and 3 years after rehabilitation. It
      is carried out as an open randomised controlled parallel group study in three hospitals in
      Hospital Unit West Jutland, Central Denmark Region, where the participants newly hospitalised
      with either ischemic heart disease or heart failure is randomised to either the intervention
      group with learning and coping strategies or to the standard group without the strategies.
      The rehabilitation courses in both groups last for eight weeks and consist of both training
      and education sessions. The concept of learning and coping is applied to the intervention
      group by letting 'experienced patients' participate in the education and not using
      standardised teaching slides. Also clarifying individual interviews are completed before and
      after the course. The 1:1 randomisation is computer generated and is stratified by hospital
      unit, diagnosis and gender. All analyses will be performed after the principle of 'intention
      to treat'.

      The primary outcomes are adherence to cardiac rehabilitation, morbidity and mortality, while
      secondary outcomes are risk factors (blood pressure and lipid profile), lifestyle (body mass
      index, waist circumference, smoking status, exercise capacity and body compositions measured
      via DXA-scans) and health related quality of life (SF-12, Health Education Impact
      Questionnaire and Major Depression Inventory) and return to work (derived from the Danish
      Register for Evaluation of Marginalisation, (DREAM))
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Adherence to cardiac rehabilitation
time frame: After 8 weeks of cardiac rehabilitation
measure: Morbidity and mortality
time frame: Three or four years after last patient into trial
measure: Risk- and lifestyle factors
time frame: At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation
measure: Health related Quality of life
time frame: At baseline, after 8 weeks of rehabilitation, at 3 months after rehabilitation and at 3 years after rehabilitation
measure: Return to work
time frame: at baseline and after one year
description: Four weeks of self support at follow up derived from the Danish Register for Evaluation of Marginalisation (DREAM)
arm group label: Learning and coping arm
arm group type: Active Comparator
description: Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.
arm group label: Control arm
arm group type: Placebo Comparator
description: Usual care. Teaching style: deductive.
intervention type: Behavioral
intervention name: Learning and coping arm
description: Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.
arm group label: Learning and coping arm
other name: Learning and coping strategies in cardiac rehabilitation
intervention type: Other
intervention name: Control arm
description: Usual care. Teaching style: deductive.
arm group label: Control arm
other name: Standard cardiac rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vibeke Lynggaard, MHsc
role: Principal Investigator
affiliation: Regional Hospital West Jutland
facility: 
country: Denmark
url: http://www.ncbi.nlm.nih.gov/pubmed/25495543
description: BMC Cardiovascular Disorders
citation: Lynggaard V, May O, Beauchamp A, Nielsen CV, Wittrup I. LC-REHAB: randomised trial assessing the effect of a new patient education method--learning and coping strategies--in cardiac rehabilitation. BMC Cardiovasc Disord. 2014 Dec 13;14:186. doi: 10.1186/1471-2261-14-186.
PMID: 25495543
responsible party type: Principal Investigator
investigator affiliation: Herning Hospital
investigator full name: Vibeke Lynggaard
investigator title: MHsc, PhD student at Cardiovasculat Research Unit