<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/NCT03835923</url>
  </required_header>
  <id_info>
    <org_study_id>01NVF17015</org_study_id>
    <secondary_id>DRKS00015140</secondary_id>
    <nct_id>NCT03835923</nct_id>
  </id_info>
  <brief_title>Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes</brief_title>
  <acronym>LeIKD</acronym>
  <official_title>Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Techniker Krankenkasse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>privates Institut für angewandte Versorgungsforschung GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IDS Diagnostic Systems AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal Joint Committee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Techniker Krankenkasse</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>
      Chronic ischemic heart disease and diabetes mellitus type II have one of the highest&#xD;
      morbidity and mortality rates. Especially in the presence of both diseases, these risks&#xD;
      increase exponentially. The aim of this program is to reduce cardiovascular risk factors by&#xD;
      promoting individual health literacy and a healthy lifestyle, thereby improving metabolism&#xD;
      and reducing the progress of the disease as well as mortality.&#xD;
&#xD;
      Patients will receive individual exercise prescriptions and nutritional recommendations. This&#xD;
      lifestyle intervention is accompanied by step counters, heart rate sensors, blood glucose&#xD;
      meters and smartphones to allow regional implementation in different areas in Germany. In&#xD;
      total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will&#xD;
      participate in the trial.&#xD;
&#xD;
      The project examines whether the intervention positively affects metabolic health and&#xD;
      lifestyle behaviors, increases health literacy, and reduces cardiovascular events of these&#xD;
      high risk patients. Furthermore, the effectiveness of the intervention will be compared&#xD;
      between urban and rural areas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic ischemic heart disease and diabetes mellitus type II have one of the highest&#xD;
      morbidity and mortality rates. Especially in the presence of both diseases, these risks&#xD;
      increase exponentially. The combined endpoint of death and myocardial infarction reaches up&#xD;
      to 30% within four years. A lifestyle intervention with exercise training and dietary change&#xD;
      can reduce the mortality by 20-30% and is a class-I indication in the current guidelines of&#xD;
      the European Association of Preventive Cardiology (EAPC). Nevertheless, the implementation of&#xD;
      lifestyle interventions in the population is insufficient.&#xD;
&#xD;
      This prospective randomized controlled trial examines whether a structured, individual and&#xD;
      telemedicine-supported lifestyle intervention improves health literacy and reduces&#xD;
      cardiovascular risk factors compared to a guideline-based recommendation (usual care).&#xD;
      Furthermore, the effectiveness of the intervention will be compared between urban and rural&#xD;
      areas.&#xD;
&#xD;
      In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease&#xD;
      will participate in the trial. After randomization (1:1), the 750 patients of the&#xD;
      intervention group will receive individual exercise prescriptions and nutritional&#xD;
      recommendations based on a maximum exercise stress test and a multi-day nutrition protocol.&#xD;
      The intervention is accompanied by pedometers, heart rate sensors, blood glucose meters and&#xD;
      smartphones as well as regular oral and written feedback.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">April 16, 2021</completion_date>
  <primary_completion_date type="Actual">December 16, 2020</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>Change in HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>measured in percent (%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>12 months</time_frame>
    <description>measured in percent (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health literacy</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>European Health Literacy Survey Questionnaire (HLS-EU-Q16)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daily physical activity</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>International Physical Activity Questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in average steps per day</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>7-day average of steps/day measured by pedometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in eating behavior</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Short form health survey (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of medical care expenses</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>routine data of health insurance company</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>measured in kilograms (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>measured in centimeters (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL-cholesterol concentrations</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>measured in milligram/deciliter (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL-cholesterol concentrations</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>measured in milligram/deciliter (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in triglyceride concentrations</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>measured in milligram/deciliter (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>measured in millimeters of mercury (mmHG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diastolic blood pressure</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>measured in millimeters of mercury (mmHG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of the combined endpoint &quot;4P-MACE&quot;</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">502</enrollment>
  <condition>Ischemic Heart Disease Chronic</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>lifestyle intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>general exercise and nutritional recommendations according to current guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lifestyle intervention</intervention_name>
    <description>intervention phase 1 (baseline - month 6): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity. The intervention is accompanied by regular oral and written feedback.&#xD;
intervention phase 2 (month 6 - month 12): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity without additional oral or written feedback.</description>
    <arm_group_label>lifestyle intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>Recommendation for lifestyle intervention at baseline and after 6 months (e.g. salt reduction, restricted alcohol consumption and smoking cessation, 10,000 steps/day, 150 minutes/week moderate intensity exercise)</description>
    <arm_group_label>usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ischemic heart disease (ICD-10: I20-I25)&#xD;
&#xD;
          -  Diabetes mellitus heart disease (ICD-10: E11)&#xD;
&#xD;
          -  insured at participating health insurance&#xD;
&#xD;
          -  permission to exercise by the study investigator&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental and behavioral disorders (ICD-10: F0-F99)&#xD;
&#xD;
          -  Heart failure NYHA IV (ICD-10: I50.14)&#xD;
&#xD;
          -  Malignant neoplasm (ICD-10: C25, C34, C56, C72, C73, C78, C79, C97)&#xD;
&#xD;
          -  Parkinson's disease (ICD-10: G20)&#xD;
&#xD;
          -  Alzheimer's disease (ICD-10: G30)&#xD;
&#xD;
          -  infantile cerebral palsy (ICD-10: G80)&#xD;
&#xD;
          -  chronic kidney disease (ICD-10: N18.4 &amp; N18.5)&#xD;
&#xD;
          -  Trisomy 21 (ICD-10: Q90)&#xD;
&#xD;
          -  Blindness / visual impairment (ICD-10: H54.0, H54.2, H54.3)&#xD;
&#xD;
          -  Hearing loss (ICD-10: H90.0, H90.3, H90.5, H90.6, H90.8)&#xD;
&#xD;
          -  Care level 1-5&#xD;
&#xD;
          -  Assured in a foreign country&#xD;
&#xD;
          -  Inability to exercise or conditions that may interfere with exercise intervention&#xD;
&#xD;
          -  No optimal medical treatment within the last 4 weeks&#xD;
&#xD;
          -  Not clinically stable within the last 4 weeks&#xD;
&#xD;
          -  Participation in another clinical trial&#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>Martin Halle, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum rechts der Isar Technische Universität München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital: Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital: Herzzentrum Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen</name>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital: Universitätsmedizin Greifswald</name>
      <address>
        <city>Greifswald</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctor's Practice: Dr. Rüdell</name>
      <address>
        <city>Kassel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital: Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital: Klinikum rechts der Isar, Technische Universität München</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Prof. Dr. med. Martin Halle</investigator_full_name>
    <investigator_title>Univ.-Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>lifestyle intervention</keyword>
  <keyword>chronic ischemic heart disease</keyword>
  <keyword>diabetes mellitus type 2</keyword>
  <keyword>cardiovascular risk factors</keyword>
  <keyword>health literacy</keyword>
  <keyword>telemedicine</keyword>
  <keyword>cross-sectoral care</keyword>
  <keyword>HbA1c</keyword>
  <keyword>individual exercise training</keyword>
  <keyword>dietary change</keyword>
  <keyword>sustainability</keyword>
  <keyword>heart disease</keyword>
  <keyword>nutrition</keyword>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <keyword>coronary artery disease</keyword>
  <keyword>coronary heart disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Ischemia</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/NCT03835923
org study id: 01NVF17015
secondary id: DRKS00015140
nct id: NCT03835923
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest
      morbidity and mortality rates. Especially in the presence of both diseases, these risks
      increase exponentially. The aim of this program is to reduce cardiovascular risk factors by
      promoting individual health literacy and a healthy lifestyle, thereby improving metabolism
      and reducing the progress of the disease as well as mortality.

      Patients will receive individual exercise prescriptions and nutritional recommendations. This
      lifestyle intervention is accompanied by step counters, heart rate sensors, blood glucose
      meters and smartphones to allow regional implementation in different areas in Germany. In
      total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will
      participate in the trial.

      The project examines whether the intervention positively affects metabolic health and
      lifestyle behaviors, increases health literacy, and reduces cardiovascular events of these
      high risk patients. Furthermore, the effectiveness of the intervention will be compared
      between urban and rural areas.
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest
      morbidity and mortality rates. Especially in the presence of both diseases, these risks
      increase exponentially. The combined endpoint of death and myocardial infarction reaches up
      to 30% within four years. A lifestyle intervention with exercise training and dietary change
      can reduce the mortality by 20-30% and is a class-I indication in the current guidelines of
      the European Association of Preventive Cardiology (EAPC). Nevertheless, the implementation of
      lifestyle interventions in the population is insufficient.

      This prospective randomized controlled trial examines whether a structured, individual and
      telemedicine-supported lifestyle intervention improves health literacy and reduces
      cardiovascular risk factors compared to a guideline-based recommendation (usual care).
      Furthermore, the effectiveness of the intervention will be compared between urban and rural
      areas.

      In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease
      will participate in the trial. After randomization (1:1), the 750 patients of the
      intervention group will receive individual exercise prescriptions and nutritional
      recommendations based on a maximum exercise stress test and a multi-day nutrition protocol.
      The intervention is accompanied by pedometers, heart rate sensors, blood glucose meters and
      smartphones as well as regular oral and written feedback.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in HbA1c
time frame: 6 months
description: measured in percent (%)
measure: Change in HbA1c
time frame: 12 months
description: measured in percent (%)
measure: Change in health literacy
time frame: 6 and 12 months
description: European Health Literacy Survey Questionnaire (HLS-EU-Q16)
measure: Change in daily physical activity
time frame: 6 and 12 months
description: International Physical Activity Questionnaire (IPAQ)
measure: Change in average steps per day
time frame: 6 and 12 months
description: 7-day average of steps/day measured by pedometers
measure: Change in eating behavior
time frame: 6 and 12 months
description: Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
measure: Change in quality of life
time frame: 6 and 12 months
description: Short form health survey (SF-36)
measure: Change of medical care expenses
time frame: 6 and 12 months
description: routine data of health insurance company
measure: Change in weight
time frame: 6 and 12 months
description: measured in kilograms (kg)
measure: Change in waist circumference
time frame: 6 and 12 months
description: measured in centimeters (cm)
measure: Change in LDL-cholesterol concentrations
time frame: 6 and 12 months
description: measured in milligram/deciliter (mg/dL)
measure: Change in HDL-cholesterol concentrations
time frame: 6 and 12 months
description: measured in milligram/deciliter (mg/dL)
measure: Change in triglyceride concentrations
time frame: 6 and 12 months
description: measured in milligram/deciliter (mg/dL)
measure: Change in systolic blood pressure
time frame: 6 and 12 months
description: measured in millimeters of mercury (mmHG)
measure: Change in diastolic blood pressure
time frame: 6 and 12 months
description: measured in millimeters of mercury (mmHG)
measure: Number of the combined endpoint "4P-MACE"
time frame: 6 and 12 months
description: cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
arm group label: lifestyle intervention
arm group type: Experimental
description: Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations
arm group label: usual care
arm group type: Active Comparator
description: general exercise and nutritional recommendations according to current guidelines
intervention type: Behavioral
intervention name: lifestyle intervention
description: intervention phase 1 (baseline - month 6): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity. The intervention is accompanied by regular oral and written feedback.
intervention phase 2 (month 6 - month 12): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity without additional oral or written feedback.
arm group label: lifestyle intervention
intervention type: Behavioral
intervention name: usual care
description: Recommendation for lifestyle intervention at baseline and after 6 months (e.g. salt reduction, restricted alcohol consumption and smoking cessation, 10,000 steps/day, 150 minutes/week moderate intensity exercise)
arm group label: usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Halle, Prof. Dr. med.
role: Principal Investigator
affiliation: Klinikum rechts der Isar Technische Universität München
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Prof. Dr. med. Martin Halle
investigator title: Univ.-Prof. Dr. med.
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Ischemia
sharing ipd: No