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Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes (LeIKD)

Primary Purpose

Ischemic Heart Disease Chronic, Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lifestyle intervention
usual care
Sponsored by
Techniker Krankenkasse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease Chronic focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
  • University Hospital: Charité - Universitätsmedizin Berlin
  • University Hospital: Herzzentrum Dresden
  • University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • University Hospital: Universitätsmedizin Greifswald
  • Doctor's Practice: Dr. Rüdell
  • University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
  • University Hospital: Magdeburg
  • University Hospital: Klinikum rechts der Isar, Technische Universität München
  • Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lifestyle intervention

usual care

Arm Description

Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations

general exercise and nutritional recommendations according to current guidelines

Outcomes

Primary Outcome Measures

Change in HbA1c
measured in percent (%)

Secondary Outcome Measures

Change in HbA1c
measured in percent (%)
Change in health literacy
European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Change in daily physical activity
International Physical Activity Questionnaire (IPAQ)
Change in average steps per day
7-day average of steps/day measured by pedometers
Change in eating behavior
Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
Change in quality of life
Short form health survey (SF-36)
Change of medical care expenses
routine data of health insurance company
Change in weight
measured in kilograms (kg)
Change in waist circumference
measured in centimeters (cm)
Change in LDL-cholesterol concentrations
measured in milligram/deciliter (mg/dL)
Change in HDL-cholesterol concentrations
measured in milligram/deciliter (mg/dL)
Change in triglyceride concentrations
measured in milligram/deciliter (mg/dL)
Change in systolic blood pressure
measured in millimeters of mercury (mmHG)
Change in diastolic blood pressure
measured in millimeters of mercury (mmHG)
Number of the combined endpoint "4P-MACE"
cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris

Full Information

First Posted
February 1, 2019
Last Updated
November 4, 2021
Sponsor
Techniker Krankenkasse
Collaborators
Technical University of Munich, privates Institut für angewandte Versorgungsforschung GmbH, IDS Diagnostic Systems AG, Federal Joint Committee
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1. Study Identification

Unique Protocol Identification Number
NCT03835923
Brief Title
Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Acronym
LeIKD
Official Title
Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
December 16, 2020 (Actual)
Study Completion Date
April 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Techniker Krankenkasse
Collaborators
Technical University of Munich, privates Institut für angewandte Versorgungsforschung GmbH, IDS Diagnostic Systems AG, Federal Joint Committee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease Chronic, Diabetes Mellitus, Type 2
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle intervention
Arm Type
Experimental
Arm Description
Telemedicine-supported lifestyle intervention trough individual structured exercise training (endurance and strength training), increase in daily physical activity, and individual nutritional recommendations
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
general exercise and nutritional recommendations according to current guidelines
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
measured in percent (%)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in HbA1c
Description
measured in percent (%)
Time Frame
12 months
Title
Change in health literacy
Description
European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Time Frame
6 and 12 months
Title
Change in daily physical activity
Description
International Physical Activity Questionnaire (IPAQ)
Time Frame
6 and 12 months
Title
Change in average steps per day
Description
7-day average of steps/day measured by pedometers
Time Frame
6 and 12 months
Title
Change in eating behavior
Description
Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
Time Frame
6 and 12 months
Title
Change in quality of life
Description
Short form health survey (SF-36)
Time Frame
6 and 12 months
Title
Change of medical care expenses
Description
routine data of health insurance company
Time Frame
6 and 12 months
Title
Change in weight
Description
measured in kilograms (kg)
Time Frame
6 and 12 months
Title
Change in waist circumference
Description
measured in centimeters (cm)
Time Frame
6 and 12 months
Title
Change in LDL-cholesterol concentrations
Description
measured in milligram/deciliter (mg/dL)
Time Frame
6 and 12 months
Title
Change in HDL-cholesterol concentrations
Description
measured in milligram/deciliter (mg/dL)
Time Frame
6 and 12 months
Title
Change in triglyceride concentrations
Description
measured in milligram/deciliter (mg/dL)
Time Frame
6 and 12 months
Title
Change in systolic blood pressure
Description
measured in millimeters of mercury (mmHG)
Time Frame
6 and 12 months
Title
Change in diastolic blood pressure
Description
measured in millimeters of mercury (mmHG)
Time Frame
6 and 12 months
Title
Number of the combined endpoint "4P-MACE"
Description
cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Halle, Prof. Dr. med.
Organizational Affiliation
Klinikum rechts der Isar Technische Universität München
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen
City
Aachen
Country
Germany
Facility Name
University Hospital: Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
University Hospital: Herzzentrum Dresden
City
Dresden
Country
Germany
Facility Name
University Hospital: Universitäts-Herzzentrum Freiburg - Bad Krozingen
City
Freiburg
Country
Germany
Facility Name
University Hospital: Universitätsmedizin Greifswald
City
Greifswald
Country
Germany
Facility Name
Doctor's Practice: Dr. Rüdell
City
Kassel
Country
Germany
Facility Name
University Hospital: Klinik und Poliklinik für Kardiologie - Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University Hospital: Magdeburg
City
Magdeburg
Country
Germany
Facility Name
University Hospital: Klinikum rechts der Isar, Technische Universität München
City
Munich
Country
Germany
Facility Name
Doctor's Practice: Prof. Dr. Jacob und Dr. Jacob
City
Villingen-Schwenningen
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35953083
Citation
Dinges SM, Krotz J, Gass F, Treitschke J, Fegers-Wustrow I, Geisberger M, Esefeld K, von Korn P, Duvinage A, Edelmann F, Wolfram O, Brandts J, Winzer EB, Wolfarth B, Freigang F, Neubauer S, Nebling T, Hackenberg B, Amelung V, Mueller S, Halle M. Cardiovascular risk factors, exercise capacity and health literacy in patients with chronic ischaemic heart disease and type 2 diabetes mellitus in Germany: Baseline characteristics of the Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes study. Diab Vasc Dis Res. 2022 Jul-Aug;19(4):14791641221113781. doi: 10.1177/14791641221113781.
Results Reference
derived
PubMed Identifier
33558354
Citation
von Korn P, Sydow H, Neubauer S, Duvinage A, Mocek A, Dinges S, Hackenberg B, Weichenberger M, Schoenfeld J, Amelung V, Mueller S, Halle M. Lifestyle Intervention in Chronic Ischaemic Heart Disease and Type 2 Diabetes (the LeIKD study): study protocol of a prospective, multicentre, randomised, controlled trial. BMJ Open. 2021 Feb 8;11(2):e042818. doi: 10.1136/bmjopen-2020-042818.
Results Reference
derived

Learn more about this trial

Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

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