Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

Conditions
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Ischemic Heart Disease Chronic, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: lifestyle intervention
* Behavioral: usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle intervention<br>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<br>* 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.<br>|
| Active Comparator: usual care<br>general exercise and nutritional recommendations according to current guidelines | Behavioral: usual care<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | measured in percent (%) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | measured in percent (%) | 12 months | 
| Change in health literacy | European Health Literacy Survey Questionnaire (HLS-EU-Q16) | 6 and 12 months | 
| Change in daily physical activity | International Physical Activity Questionnaire (IPAQ) | 6 and 12 months | 
| Change in average steps per day | 7-day average of steps/day measured by pedometers | 6 and 12 months | 
| Change in eating behavior | Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior) | 6 and 12 months | 
| Change in quality of life | Short form health survey (SF-36) | 6 and 12 months | 
| Change of medical care expenses | routine data of health insurance company | 6 and 12 months | 
| Change in weight | measured in kilograms (kg) | 6 and 12 months | 
| Change in waist circumference | measured in centimeters (cm) | 6 and 12 months | 
| Change in LDL-cholesterol concentrations | measured in milligram/deciliter (mg/dL) | 6 and 12 months | 
| Change in HDL-cholesterol concentrations | measured in milligram/deciliter (mg/dL) | 6 and 12 months | 
| Change in triglyceride concentrations | measured in milligram/deciliter (mg/dL) | 6 and 12 months | 
| Change in systolic blood pressure | measured in millimeters of mercury (mmHG) | 6 and 12 months | 
| Change in diastolic blood pressure | measured in millimeters of mercury (mmHG) | 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 | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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