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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
502
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.
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)
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
Aachen, Germany
University Hospital: Charité - Universitätsmedizin Berlin
Berlin, Germany
University Hospital: Herzzentrum Dresden
Dresden, Germany
University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, Germany
University Hospital: Universitätsmedizin Greifswald
Greifswald, Germany
Doctor's Practice: Dr. Rüdell
Kassel, Germany
University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
Leipzig, Germany
University Hospital: Magdeburg
Magdeburg, Germany
University Hospital: Klinikum rechts der Isar, Technische Universität München
Munich, Germany
Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob
Villingen-Schwenningen, Germany
Change in HbA1c
measured in percent (%)
Time frame: 6 months
Change in HbA1c
measured in percent (%)
Time frame: 12 months
Change in health literacy
European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Time frame: 6 and 12 months
Change in daily physical activity
International Physical Activity Questionnaire (IPAQ)
Time frame: 6 and 12 months
Change in average steps per day
7-day average of steps/day measured by pedometers
Time frame: 6 and 12 months
Change in eating behavior
Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
Time frame: 6 and 12 months
Change in quality of life
Short form health survey (SF-36)
Time frame: 6 and 12 months
Change of medical care expenses
routine data of health insurance company
Time frame: 6 and 12 months
Change in weight
measured in kilograms (kg)
Time frame: 6 and 12 months
Change in waist circumference
measured in centimeters (cm)
Time frame: 6 and 12 months
Change in LDL-cholesterol concentrations
measured in milligram/deciliter (mg/dL)
Time frame: 6 and 12 months
Change in HDL-cholesterol concentrations
measured in milligram/deciliter (mg/dL)
Time frame: 6 and 12 months
Change in triglyceride concentrations
measured in milligram/deciliter (mg/dL)
Time frame: 6 and 12 months
Change in systolic blood pressure
measured in millimeters of mercury (mmHG)
Time frame: 6 and 12 months
Change in diastolic blood pressure
measured in millimeters of mercury (mmHG)
Time frame: 6 and 12 months
Number of the combined endpoint "4P-MACE"
cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
Time frame: 6 and 12 months
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