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Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes (LeIKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835923
Recruitment Status : Active, not recruiting
First Posted : February 11, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Technische Universität München
privates Institut für angewandte Versorgungsforschung GmbH
IDS Diagnostic Systems AG
Federal Joint Committee, Germany
Information provided by (Responsible Party):
Prof. Dr. med. Martin Halle, Technische Universität München

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 11, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE February 12, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
Change in HbA1c [ Time Frame: 6 months ]
measured in percent (%)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • Change in HbA1c [ Time Frame: 12 months ]
    measured in percent (%)
  • Change in health literacy [ Time Frame: 6 and 12 months ]
    European Health Literacy Survey Questionnaire (HLS-EU-Q16)
  • Change in daily physical activity [ Time Frame: 6 and 12 months ]
    International Physical Activity Questionnaire (IPAQ)
  • Change in average steps per day [ Time Frame: 6 and 12 months ]
    7-day average of steps/day measured by pedometers
  • Change in eating behavior [ Time Frame: 6 and 12 months ]
    Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
  • Change in quality of life [ Time Frame: 6 and 12 months ]
    Short form health survey (SF-36)
  • Change of medical care expenses [ Time Frame: 6 and 12 months ]
    routine data of health insurance company
  • Change in weight [ Time Frame: 6 and 12 months ]
    measured in kilograms (kg)
  • Change in waist circumference [ Time Frame: 6 and 12 months ]
    measured in centimeters (cm)
  • Change in LDL-cholesterol concentrations [ Time Frame: 6 and 12 months ]
    measured in milligram/deciliter (mg/dL)
  • Change in HDL-cholesterol concentrations [ Time Frame: 6 and 12 months ]
    measured in milligram/deciliter (mg/dL)
  • Change in triglyceride concentrations [ Time Frame: 6 and 12 months ]
    measured in milligram/deciliter (mg/dL)
  • Change in systolic blood pressure [ Time Frame: 6 and 12 months ]
    measured in millimeters of mercury (mmHG)
  • Change in diastolic blood pressure [ Time Frame: 6 and 12 months ]
    measured in millimeters of mercury (mmHG)
  • Number of the combined endpoint "4P-MACE" [ Time Frame: 6 and 12 months ]
    cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • Change in HbA1c [ Time Frame: 12 months ]
    measured in percent (%)
  • Change in health literacy [ Time Frame: 6 and 12 months ]
    European Health Literacy Survey Questionnaire (HLS-EU-Q16)
  • Change in daily physical activity [ Time Frame: 6 and 12 months ]
    International Physical Activity Questionnaire (IPAQ)
  • Change in average steps per day [ Time Frame: 6 and 12 months ]
    7-day average of steps/day measured by pedometers
  • Change in eating behavior [ Time Frame: 6 and 12 months ]
    Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
  • Change in quality of life [ Time Frame: 6 and 12 months ]
    Short form health survey (SF-36)
  • Change of medical care expenses [ Time Frame: 6 and 12 months ]
    routine data of health insurance company
  • Change in weight [ Time Frame: 6 and 12 months ]
    measured in kilograms (kg)
  • Change in waist circumference [ Time Frame: 6 and 12 months ]
    measured in centimeters (cm)
  • Change in LDL-cholesterol concentrations [ Time Frame: 6 and 12 months ]
    measured in centimeters (cm)
  • Change in HDL-cholesterol concentrations [ Time Frame: 6 and 12 months ]
    measured in milligram/deciliter (mg/dL)
  • Change in triglyceride concentrations [ Time Frame: 6 and 12 months ]
    measured in milligram/deciliter (mg/dL)
  • Change in systolic blood pressure [ Time Frame: 6 and 12 months ]
    measured in millimeters of mercury (mmHG)
  • Change in diastolic blood pressure [ Time Frame: 6 and 12 months ]
    measured in millimeters of mercury (mmHG)
  • Number of the combined endpoint "4P-MACE" [ Time Frame: 6 and 12 months ]
    cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Official Title  ICMJE Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Heart Disease Chronic
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Behavioral: lifestyle intervention

    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.

  • Behavioral: usual care
    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)
Study Arms  ICMJE
  • Experimental: lifestyle intervention
    Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations
    Intervention: Behavioral: lifestyle intervention
  • Active Comparator: usual care
    general exercise and nutritional recommendations according to current guidelines
    Intervention: Behavioral: usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ischemic heart disease (ICD-10: I20-I25)
  • Diabetes mellitus heart disease (ICD-10: E11)
  • insured at participating health insurance
  • permission to exercise by the study investigator
  • written informed consent

Exclusion Criteria:

  • Mental and behavioral disorders (ICD-10: F0-F99)
  • Heart failure NYHA IV (ICD-10: I50.14)
  • Malignant neoplasm (ICD-10: C25, C34, C56, C72, C73, C78, C79, C97)
  • Parkinson's disease (ICD-10: G20)
  • Alzheimer's disease (ICD-10: G30)
  • infantile cerebral palsy (ICD-10: G80)
  • chronic kidney disease (ICD-10: N18.4 & N18.5)
  • Trisomy 21 (ICD-10: Q90)
  • Blindness / visual impairment (ICD-10: H54.0, H54.2, H54.3)
  • Hearing loss (ICD-10: H90.0, H90.3, H90.5, H90.6, H90.8)
  • Care level 1-5
  • Assured in a foreign country
  • Inability to exercise or conditions that may interfere with exercise intervention
  • No optimal medical treatment within the last 4 weeks
  • Not clinically stable within the last 4 weeks
  • Participation in another clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03835923
Other Study ID Numbers  ICMJE 01NVF17015
DRKS00015140 ( Registry Identifier: German Clinical Trials Register )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dr. med. Martin Halle, Technische Universität München
Study Sponsor  ICMJE Techniker Krankenkasse
Collaborators  ICMJE
  • Technische Universität München
  • privates Institut für angewandte Versorgungsforschung GmbH
  • IDS Diagnostic Systems AG
  • Federal Joint Committee, Germany
Investigators  ICMJE
Principal Investigator: Martin Halle, Prof. Dr. med. Klinikum rechts der Isar Technische Universität München
PRS Account Techniker Krankenkasse
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP