Trial document
DRKS00015140
Trial Description
Title
Lifestyle Intervention in Chronic ischemic heart disease and Diabetes
Trial Acronym
LeIKD
URL of the Trial
Brief Summary in Lay Language
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates in Germany. 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 reducing the progress of the disease and the mortality of the patients.
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 it will be tested if the medical care for both urban and rural areas can be aligned.
Brief Summary in Scientific Language
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates in Germany. Especially in the presence of both diseases, these risks increase exponentially. The combined endpoint of death and myocardial infarction is 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 EACP (European Association of Preventive Cardiology). 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 it will be tested if the medical care for both urban and rural areas can be aligned.
In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial. The primary endpoint is a change in HbA1c after six months. Secondary endpoints include, amongst others, a change in health literacy, quality of life, daily physical activity, eating behavior and medical care expenses as well as the number of major cardiovascular adverse events. 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.
Initial telephone contact with insured patients by health insurance company: 15/12/2018
anticipated first screening: 11/02/2019
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00015140
- 2019/01/10
- [---]*
- yes
- Approved
- 144/18 S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
Secondary IDs
- U1111-1217-6306
Health Condition or Problem studied
- I25 - Chronic ischaemic heart disease
- E11 - Type 2 diabetes mellitus
Interventions/Observational Groups
-
intervention phase 1 (week 1 – week 26):
Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations, accompanied by regular oral and written feedback.
intervention phase 2 (week 27 – week 52):
Continuation of exercise training, daily physical activity and balanced diet without additional oral or written feedback. Patients receive a single feedback based on the results of the examination. -
intervention phase 1 (week 1 – week 26):
general exercise and nutritional recommendations according to current guidelines
intervention phase 2 (week 27 – week 52):
general exercise and nutritional recommendations according to current guidelines
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- data analyst
- Active control (effective treament of control group)
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
Change in HbA1c (%) within 6 months
Secondary Outcome
1) Change in HbA1c (%) within 12 months
2) Change in health literacy (European Health Literacy Survey Questionnaire (HLS-EU-Q16)) within 6 and 12 months
3) Change in daily physical activity (International Physical Activity Questionnaire (IPAQ)) within 6 and 12 months
4) Change in average steps per day (7-day average of steps/day measured by pedometers) within 6 and 12 months
5) Change in eating behavior (Fragebogen zum Essverhalten (FEV); German questionnaire on eating behavior) within 6 and 12 months
6) Change in quality of life (Short form health survey (SF-36)) within 6 and 12 months
7) Change in medical care expenses (routine data of health insurance) within 6 and 12 months
8) Change in weight (kg) within 6 and 12 months
9) Change in waist circumference (cm) within 6 and 12 months
10) Change in LDL-cholesterol concentrations (mg/dL) within 6 and 12 months
11) Change in HDL-cholesterol concentrations (mg/dL) within 6 and 12 months
12) Change in triglyceride concentrations (mg/dL) within 6 and 12 months
13) Change in systolic blood pressure (mmHG) within 6 and 12 months
14) Change in diastolic blood pressure (mmHG) within 6 and 12 months
15) Number of the combined endpoint “4P-MACE” (cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris) within 6 and 12 months
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- Doctor's Practice
- University Medical Center
Recruitment
- Actual
- 2019/02/12
- 1500
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Insured at participating health insurance,
Chronic ischemic heart disease (ICD-10: I25),
Diabetes mellitus type II (ICD-10: E11),
Permission to do sports 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
Addresses
-
start of 1:1-Block address primary-sponsor
- Techniker Krankenkasse
- Ms. Sarah Neubauer
- Bramfelder Straße 140
- 22305 Hamburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 040 - 69 09-3047
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- sarah.neubauer at tk.de
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Lehrstuhl für präventive und rehabilitative Sportmedizin, Klinikum rechts der Isar der TU München
- Mr. Prof. Dr. med. Martin Halle
- Georg-Brauchle-Ring 56-48
- 80992 München
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- leikd.info(at)mri.tum.de
- http://www.sport.mri.tum.de
end of 1:1-Block address contact other -
start of 1:1-Block address other
- IDS Diagnostic Systems AG
- Mr. Dr. Björn Hackenberg
- Zehntwiesenstraße 35 b
- 76275 Ettlingen
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- [---]*
- http://www.ids-ds.de
end of 1:1-Block address contact other -
start of 1:1-Block address other
- inav - privates Institut für angewandte Versorgungsforschung GmbH
- Mr. Prof. Dr. Volker Amelung
- Schiffbauerdamm 12
- 10117 Berlin
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
- [---]*
- leikd(at)inav-berlin.de
- http://www.inav-berlin.de
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Lehrstuhl für präventive und rehabilitative Sportmedizin, Klinikum rechts der Isar der TU München
- Mr. Prof. Dr. med Martin Halle
- Georg-Brauchle-Ring 56-58
- 80992 München
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- DE 089 - 289 24431
- [---]*
- leikd.info(at)mri.tum.de
- http://www.sport.mri.tum.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Lehrstuhl für präventive und rehabilitative Sportmedizin, Klinikum rechts der Isar der TU München
- Mr. Dr. med. Andrè Duvinage
- Georg-Brauchle-Ring 56-58
- 80992 München
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- DE 089 - 289 24454
- [---]*
- leikd.info(at)mri.tum.de
- http://www.sport.mri.tum.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Gemeinsamer Bundesausschuss
- Gutenbergstraße 13
- 10587 Berlin
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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