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PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention | Clinical Trials | Clareo Health

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

NCT05887180•Charite University, Berlin, Germany

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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

Key Dates

Start Date

January 1, 2022

Primary Completion Date

June 30, 2024

Completion Date

June 30, 2025

Last Updated

June 7, 2023

Enrollment

209

ACTUAL participants

Conditions

Type 2 DiabetesArteriosclerosisArterial HypertensionLipid Metabolism Disorders

Interventions

PräVaNet-Intervention

OTHER

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D

Closed-loop in Adults With Type 2 Diabetes