Back to resultsPräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention (PräVaNet)
Primary Purpose
Type 2 Diabetes, Arteriosclerosis, Arterial Hypertension
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PräVaNet-Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring E-Health, Telemedicine, Prevention
Eligibility Criteria
Inclusion Criteria: Included are patients who at baseline: Are at least 18 years or older Living in the German federal states of Berlin or Brandenburg Insured by the cooperating German SHI company Diagnosed with type 2 diabetes mellitus at least 3 months prior to study entry and who Require drug therapy for diabetes mellitus type 2; i.e., received at least 1 oral antidiabetic drug or insulin therapy for at least 3 months prior to study entry; such a need for drug therapy should also exist at the start of the study for the next year and beyond and Fulfill at least one of the following criteria: metabolic syndrome: 3 of the following 4 criteria: Waist-to-hip ratio (WHR) > 94 cm/80 cm; triglycerides ≥ 150 md/dl or cholesterol- or lipid-lowering therapy; high density lipoprotein (HDL) < 40/50 mg/dl or cholesterol- or lipid-lowering therapy; hypertension ≥ 135/85 mmHg or antihypertensive therapy; and/or macrovascular manifestations (coronary artery disease (CAD) and/or peripheral arterial disease (CAD) and/or carotid stenosis) and/or microvascular manifestation (chronic renal failure with estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2). Exclusion Criteria: Patients with at least one of the following characteristics are excluded from participation: Chronic disease and, in this context, an anticipated life expectancy of less than 21 months; Renal failure requiring dialysis; Lipid metabolism disorder and indication for lipid apheresis; Mental illness requiring therapy; Lack of ability to use E-Health technologies; Participation in another intervention study.
Sites / Locations
- Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PräVaNet-Intervention
Standard of Care
Arm Description
Interdisciplinary Online-Board, close patient care by a specially trained nurse, E-Health-platform with physician cockpit, patient App, sensor kit (ECG-capable pulse watch, digital blood pressure monitor, digital blood glucose meter if required) and a telemonitoring/alarm system.
Standard of Care according to currently valid guidelines.
Outcomes
Primary Outcome Measures
Rate of adverse cardiovascular and cerebrovascular events (MACCE "Plus" events)
MACCE "Plus" is defined as an index derived from the incidence of major cardiovascular complications (acute coronary syndrome, stroke/transient ischemic attack), death of any etiology, and unplanned hospitalization for any of the following discharge diagnoses: Hyper-glycemia, Hypoglycemia, Amputation, Ischemic Gangrene, Acute Renal Failure with/without Dialysis Requirement, Heart Failure Decompensation, Coronary Revascularization for Unstable Angina.
Secondary Outcome Measures
Cardiovascular risk
A change in the prevalence and treatment quality of cardiovascular risk factors according to a change in the Framingham Risk Score and according to the prevalence of the individual risk factors.
Complication rate
e.g., atrial fibrillation, hypoglycemia, diabetic nephropathy
Adherence to therapy
assessment of medication adherence and assessment of adherence with dietary and exercise measured on a scale from 1=not adherent to 10=fully adherent
Changes in self-reported quality of life
Changes in self-reported quality of life, assessed by the EQ-5D-5L. The EQ-5D-5L consists of 5 dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety to depression measured on a five-point scale describing the degree of problems in that area (1-no problems to 5-very severe problems)) and results in a single index.
Changes in patient reported quality of care
Changes in patient reported quality of care, measured by the Patient Assessment of Chronic Illness Care (PACIC-5A): 26 items questionnaire measured on a likert scale ranging from min: 1 to max: 5, assessing the patient's perception of greater involvement and receipt of chronic care counseling according to the Chronic Care Model. Higher scores indicate higher quality of care.
Changes in patient reported physical, psychological and social health
Changes in patient reported physical, psychological and social health by using the Patient-Reported Outcomes Measurement Information System (PROMIS®): pain intensity (0-10 numeric rating item) and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain, each measured on a likert scale of answers ranging from 1-5. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10. The higher the T-score points, the better the health status.
Changes in diabetes self-care activities
Changes in diabetes self-care activities, measured by the Diabetes Self-Management Questionnaire (DSMQ): scale min = 1; scale max = 4; higher scores mean better treatment behavior
Inpatient health care utilization
Measured by % of patients with hospitalizations/utilized inpatient health care services assessed by SHI data.
Direct medical costs of intervention and control group patients
Relative share of outpatient costs, inpatient costs and pharmaceutical costs in total direct medical costs
Costs of work incapacity / early retirement of intervention and control group patients
Incremental cost-effectiveness ratio (ICER) using the primary outcome measure (MACCE "Plus" events) as the effectiveness criterion (cost-effectiveness analysis)
Incremental cost-utility relation (societal perspective)
cost-utility analysis: incremental cost-utility ratio using health-related quality of life as utility (complemented by length of health state for calculation of quality-adjusted-life-years (QALYs))
Full Information
NCT ID
NCT05887180
First Posted
April 5, 2023
Last Updated
June 5, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Association of Statutory Health Insurance Physicians (KV Berlin), Statutory health insurance provider AOK Nordost, German Foundation for the Chronically ill (DScK), aQua - Institute for Applied Quality Improvement and Research in Health Care GmbH, Scientific Institute for Health Economics and Health System Research (WIG2)
1. Study Identification
Unique Protocol Identification Number
NCT05887180
Brief Title
PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention
Acronym
PräVaNet
Official Title
PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Association of Statutory Health Insurance Physicians (KV Berlin), Statutory health insurance provider AOK Nordost, German Foundation for the Chronically ill (DScK), aQua - Institute for Applied Quality Improvement and Research in Health Care GmbH, Scientific Institute for Health Economics and Health System Research (WIG2)
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
PräVaNet is a prospective, 1:1 randomized, controlled trial to investigate the efficacy of a new, digitalized prevention strategy ("ePrevention") in cardiovascular high-risk patients with type 2 diabetes mellitus in the outpatient sector.
Detailed Description
PräVaNet is an interdisciplinary and digitally supported prevention concept based on a specialist online board, close patient care by a specially trained nurse, an E-Health platform with physician cockpit, patient App, a smart sensor kit (ECG-capable pulse watch, digital blood pressure monitor, digital blood glucose meter if required) and a telemonitoring/alarm system.
The aim of PräVaNet is to prevent a worsening of the condition of cardiovascular high-risk patients with type 2 diabetes through intensified and continuous risk factor monitoring as well as guideline- and needs-based patient treatment and care. Serious, cost-intensive (especially cardiovascular) secondary diseases are to be avoided and the quality of life of those affected is to be maintained or improved. PräVaNet includes intensive patient education to improve personal responsibility and self-management of the disease and the individual cardiovascular risk.
PräVaNet is the first clinical study evaluating effectiveness and safety of an ePrevention-concept in cardiovascular high-risk patients with type 2 diabetes mellitus in Germany.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Arteriosclerosis, Arterial Hypertension, Lipid Metabolism Disorders
Keywords
E-Health, Telemedicine, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned to 1 of 2 possible treatment arms (standard of care vs. intervention)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PräVaNet-Intervention
Arm Type
Experimental
Arm Description
Interdisciplinary Online-Board, close patient care by a specially trained nurse, E-Health-platform with physician cockpit, patient App, sensor kit (ECG-capable pulse watch, digital blood pressure monitor, digital blood glucose meter if required) and a telemonitoring/alarm system.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care according to currently valid guidelines.
Intervention Type
Other
Intervention Name(s)
PräVaNet-Intervention
Intervention Description
interdisciplinary and digitally supported prevention concept
Primary Outcome Measure Information:
Title
Rate of adverse cardiovascular and cerebrovascular events (MACCE "Plus" events)
Description
MACCE "Plus" is defined as an index derived from the incidence of major cardiovascular complications (acute coronary syndrome, stroke/transient ischemic attack), death of any etiology, and unplanned hospitalization for any of the following discharge diagnoses: Hyper-glycemia, Hypoglycemia, Amputation, Ischemic Gangrene, Acute Renal Failure with/without Dialysis Requirement, Heart Failure Decompensation, Coronary Revascularization for Unstable Angina.
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Cardiovascular risk
Description
A change in the prevalence and treatment quality of cardiovascular risk factors according to a change in the Framingham Risk Score and according to the prevalence of the individual risk factors.
Time Frame
20 months
Title
Complication rate
Description
e.g., atrial fibrillation, hypoglycemia, diabetic nephropathy
Time Frame
20 months
Title
Adherence to therapy
Description
assessment of medication adherence and assessment of adherence with dietary and exercise measured on a scale from 1=not adherent to 10=fully adherent
Time Frame
20 months
Title
Changes in self-reported quality of life
Description
Changes in self-reported quality of life, assessed by the EQ-5D-5L. The EQ-5D-5L consists of 5 dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety to depression measured on a five-point scale describing the degree of problems in that area (1-no problems to 5-very severe problems)) and results in a single index.
Time Frame
20 months
Title
Changes in patient reported quality of care
Description
Changes in patient reported quality of care, measured by the Patient Assessment of Chronic Illness Care (PACIC-5A): 26 items questionnaire measured on a likert scale ranging from min: 1 to max: 5, assessing the patient's perception of greater involvement and receipt of chronic care counseling according to the Chronic Care Model. Higher scores indicate higher quality of care.
Time Frame
20 months
Title
Changes in patient reported physical, psychological and social health
Description
Changes in patient reported physical, psychological and social health by using the Patient-Reported Outcomes Measurement Information System (PROMIS®): pain intensity (0-10 numeric rating item) and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain, each measured on a likert scale of answers ranging from 1-5. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10. The higher the T-score points, the better the health status.
Time Frame
20 months
Title
Changes in diabetes self-care activities
Description
Changes in diabetes self-care activities, measured by the Diabetes Self-Management Questionnaire (DSMQ): scale min = 1; scale max = 4; higher scores mean better treatment behavior
Time Frame
20 months
Title
Inpatient health care utilization
Description
Measured by % of patients with hospitalizations/utilized inpatient health care services assessed by SHI data.
Time Frame
20 months
Title
Direct medical costs of intervention and control group patients
Time Frame
20 months
Title
Relative share of outpatient costs, inpatient costs and pharmaceutical costs in total direct medical costs
Time Frame
20 months
Title
Costs of work incapacity / early retirement of intervention and control group patients
Time Frame
20 months
Title
Incremental cost-effectiveness ratio (ICER) using the primary outcome measure (MACCE "Plus" events) as the effectiveness criterion (cost-effectiveness analysis)
Time Frame
20 months
Title
Incremental cost-utility relation (societal perspective)
Description
cost-utility analysis: incremental cost-utility ratio using health-related quality of life as utility (complemented by length of health state for calculation of quality-adjusted-life-years (QALYs))
Time Frame
20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Included are patients who at baseline:
Are at least 18 years or older
Living in the German federal states of Berlin or Brandenburg
Insured by the cooperating German SHI company
Diagnosed with type 2 diabetes mellitus at least 3 months prior to study entry and who
Require drug therapy for diabetes mellitus type 2; i.e., received at least 1 oral antidiabetic drug or insulin therapy for at least 3 months prior to study entry; such a need for drug therapy should also exist at the start of the study for the next year and beyond
and
Fulfill at least one of the following criteria:
metabolic syndrome: 3 of the following 4 criteria: Waist-to-hip ratio (WHR) > 94 cm/80 cm; triglycerides ≥ 150 md/dl or cholesterol- or lipid-lowering therapy; high density lipoprotein (HDL) < 40/50 mg/dl or cholesterol- or lipid-lowering therapy; hypertension ≥ 135/85 mmHg or antihypertensive therapy;
and/or
macrovascular manifestations (coronary artery disease (CAD) and/or peripheral arterial disease (CAD) and/or carotid stenosis)
and/or
microvascular manifestation (chronic renal failure with estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2).
Exclusion Criteria:
Patients with at least one of the following characteristics are excluded from participation:
Chronic disease and, in this context, an anticipated life expectancy of less than 21 months;
Renal failure requiring dialysis;
Lipid metabolism disorder and indication for lipid apheresis;
Mental illness requiring therapy;
Lack of ability to use E-Health technologies;
Participation in another intervention study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sinning, MD
Organizational Affiliation
Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine
City
Berlin
ZIP/Postal Code
12203
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://kardio-cbf.charite.de/forschung/innovationsfonds_projekt_praevanet/
Description
Project website
Learn more about this trial
PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention
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