Diabetes Mellitus, Type 2, Ischemic Heart Disease Chronic
Conditions
Keywords
lifestyle intervention, chronic ischemic heart disease, diabetes mellitus type 2, cardiovascular risk factors, 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
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.
Interventions
BEHAVIORALlifestyle 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.
BEHAVIORALusual 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)
Sponsors
Technical University of Munich
privates Institut für angewandte Versorgungsforschung GmbH
IDS Diagnostic Systems AG
Federal Joint Committee
Techniker Krankenkasse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 6 months | measured in percent (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in health literacy | 6 and 12 months | European Health Literacy Survey Questionnaire (HLS-EU-Q16) |
| Change in daily physical activity | 6 and 12 months | International Physical Activity Questionnaire (IPAQ) |
| Change in average steps per day | 6 and 12 months | 7-day average of steps/day measured by pedometers |
| Change in eating behavior | 6 and 12 months | Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior) |
| Change in quality of life | 6 and 12 months | Short form health survey (SF-36) |
| Change of medical care expenses | 6 and 12 months | routine data of health insurance company |
| Change in weight | 6 and 12 months | measured in kilograms (kg) |
| Change in HbA1c | 12 months | measured in percent (%) |
| Change in LDL-cholesterol concentrations | 6 and 12 months | measured in milligram/deciliter (mg/dL) |
| Change in HDL-cholesterol concentrations | 6 and 12 months | measured in milligram/deciliter (mg/dL) |
| Change in triglyceride concentrations | 6 and 12 months | measured in milligram/deciliter (mg/dL) |
| Change in systolic blood pressure | 6 and 12 months | measured in millimeters of mercury (mmHG) |
| Change in diastolic blood pressure | 6 and 12 months | measured in millimeters of mercury (mmHG) |
| Number of the combined endpoint 4P-MACE | 6 and 12 months | cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris |
| Change in waist circumference | 6 and 12 months | measured in centimeters (cm) |
Countries
Germany
Outcome results
None listed