PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention

Charite University, Berlin, Germany209 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

209

Conditions

Type 2 Diabetes Arteriosclerosis Arterial Hypertension Lipid Metabolism Disorders

Interventions

PräVaNet-InterventionOTHER

interdisciplinary and digitally supported prevention concept

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. 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 2. macrovascular manifestations (coronary artery disease (CAD) and/or peripheral arterial disease (CAD) and/or carotid stenosis) and/or 3. 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.

Locations (1)

Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine

Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: 20 months

Secondary Outcomes

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.

Time frame: 20 months

Complication rate

e.g., atrial fibrillation, hypoglycemia, diabetic nephropathy

Time frame: 20 months

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

Time frame: 20 months

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.

Time frame: 20 months

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.

Data from ClinicalTrials.gov

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