PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 209
- Locations
- 1
- Primary Endpoint
- Rate of adverse cardiovascular and cerebrovascular events (MACCE "Plus" events)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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;
- •macrovascular manifestations (coronary artery disease (CAD) and/or peripheral arterial disease (CAD) and/or carotid stenosis)
- •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.
Arms & Interventions
PräVaNet-Intervention
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.
Intervention: PräVaNet-Intervention (Other)
Standard of Care
Standard of Care according to currently valid guidelines.
Outcomes
Primary Outcomes
Rate of adverse cardiovascular and cerebrovascular events (MACCE "Plus" events)
Time Frame: 20 months
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 Outcomes
- Costs of work incapacity / early retirement of intervention and control group patients(20 months)
- Cardiovascular risk(20 months)
- Complication rate(20 months)
- Changes in patient reported quality of care(20 months)
- Changes in patient reported physical, psychological and social health(20 months)
- Inpatient health care utilization(20 months)
- Direct medical costs of intervention and control group patients(20 months)
- Incremental cost-effectiveness ratio (ICER) using the primary outcome measure (MACCE "Plus" events) as the effectiveness criterion (cost-effectiveness analysis)(20 months)
- Incremental cost-utility relation (societal perspective)(20 months)
- Changes in diabetes self-care activities(20 months)
- Adherence to therapy(20 months)
- Changes in self-reported quality of life(20 months)
- Relative share of outpatient costs, inpatient costs and pharmaceutical costs in total direct medical costs(20 months)
Investigators
Dr. med. David Sinning
Dr. med.
German Heart Institute