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

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ClinicalTrials.gov Identifier: NCT03835923
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
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

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.


Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Chronic Diabetes Mellitus, Type 2 Behavioral: lifestyle intervention Behavioral: usual care Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.


Active Comparator: usual care
general exercise and nutritional recommendations according to current guidelines
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)




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 6 months ]
    measured in percent (%)


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 12 months ]
    measured in percent (%)

  2. Change in health literacy [ Time Frame: 6 and 12 months ]
    European Health Literacy Survey Questionnaire (HLS-EU-Q16)

  3. Change in daily physical activity [ Time Frame: 6 and 12 months ]
    International Physical Activity Questionnaire (IPAQ)

  4. Change in average steps per day [ Time Frame: 6 and 12 months ]
    7-day average of steps/day measured by pedometers

  5. Change in eating behavior [ Time Frame: 6 and 12 months ]
    Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)

  6. Change in quality of life [ Time Frame: 6 and 12 months ]
    Short form health survey (SF-36)

  7. Change of medical care expenses [ Time Frame: 6 and 12 months ]
    routine data of health insurance company

  8. Change in weight [ Time Frame: 6 and 12 months ]
    measured in kilograms (kg)

  9. Change in waist circumference [ Time Frame: 6 and 12 months ]
    measured in centimeters (cm)

  10. Change in LDL-cholesterol concentrations [ Time Frame: 6 and 12 months ]
    measured in centimeters (cm)

  11. Change in HDL-cholesterol concentrations [ Time Frame: 6 and 12 months ]
    measured in milligram/deciliter (mg/dL)

  12. Change in triglyceride concentrations [ Time Frame: 6 and 12 months ]
    measured in milligram/deciliter (mg/dL)

  13. Change in systolic blood pressure [ Time Frame: 6 and 12 months ]
    measured in millimeters of mercury (mmHG)

  14. Change in diastolic blood pressure [ Time Frame: 6 and 12 months ]
    measured in millimeters of mercury (mmHG)

  15. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic ischemic heart disease (ICD-10: 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835923


Contacts
Contact: André Duvinage, Dr. med. +49 (0)89 289 24454 leikd.info@mri.tum.de

Locations
Germany
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen Not yet recruiting
Aachen, Germany
University Hospital: Charité - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany
University Hospital: Herzzentrum Dresden Not yet recruiting
Dresden, Germany
University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen Not yet recruiting
Freiburg, Germany
University Hospital: Universitätsmedizin Greifswald Not yet recruiting
Greifswald, Germany
University Hospital: Universitätsmedizin Göttingen Not yet recruiting
Göttingen, Germany
Doctor's Practice: Dr. Rüdell Not yet recruiting
Kassel, Germany
University Hospital: Magdeburg Not yet recruiting
Magdeburg, Germany
University Hospital: Klinikum rechts der Isar, Technische Universität München Not yet recruiting
Munich, Germany
Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob Not yet recruiting
Villingen-Schwenningen, Germany
Sponsors and Collaborators
Techniker Krankenkasse
Technische Universität München
privates Institut für angewandte Versorgungsforschung GmbH
IDS Diagnostic Systems AG
Federal Joint Committee, Germany
Investigators
Principal Investigator: Martin Halle, Prof. Dr. med. Klinikum rechts der Isar Technische Universität München

Responsible Party: Prof. Dr. med. Martin Halle, Univ.-Prof. Dr. med., Technische Universität München
ClinicalTrials.gov Identifier: NCT03835923     History of Changes
Other Study ID Numbers: 01NVF17015
DRKS00015140 ( Registry Identifier: German Clinical Trials Register )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. med. Martin Halle, Technische Universität München:
cardiovascular risk factors
lifestyle intervention
chronic ischemic heart disease
diabetes mellitus type 2
health literacy
telemedicine
cross-sectoral care
HbA1c
individual exercise training
dietary change
sustainability
heart disease
nutrition
exercise
physical activity
coronary artery disease
coronary heart disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Ischemia
Heart Diseases
Diabetes Mellitus, Type 2
Myocardial Ischemia
Coronary Artery Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases