NCT03835923

Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Techniker Krankenkasse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Heart Disease Chronic
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-02-12
• Primary completion: 2020-12-16
• Completion: 2021-04-16
• First posted: 2019-02-11
• Last updated: 2021-11-05

Locations

10 sites across 1 country: Germany