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

Charité University Medicine Berlin

Status: Active, not recruiting

Conditions: Lipid Metabolism Disorders; Arterial Hypertension; Type 2 Diabetes; Arteriosclerosis

Treatments: Other: PräVaNet-Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05887180

01NVF20001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

  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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

PräVaNet-Intervention

Experimental group

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.

Treatment:

Other: PräVaNet-Intervention

Standard of Care

No Intervention group

Description:

Standard of Care according to currently valid guidelines.