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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

VA|PREVENTION: Randomized Controlled Trial of a Person-Centred Digital Intervention to Prevent Diabetes in High-Risk Adults

NCT07021144

Pre-diabetes Pre-diabetic State

ACTIVE_NOT_RECRUITING NA

Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard)

NCT02759055

Pre-diabetes

COMPLETED NA

Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease

NCT05459987

Prediabetic State Coronary Heart Disease Healthy Lifestyle +1 more

COMPLETED NA

Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention

NCT06911294

Coronary Heart Disease

RECRUITING NA

Novel Risk Prediction Approaches for the Primary Prevention of Cardiovascular Diseases in Italy: the CVRISK-IT Trial (CVRISK-IT)

NCT06832644

Cardiovascular Risk Genetic Cardiovascular Risk

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Arteriosclerosis Arterial Hypertension Lipid Metabolism Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomly assigned to 1 of 2 possible treatment arms (standard of care vs. intervention)

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

PräVaNet-Intervention

Intervention Type OTHER

interdisciplinary and digitally supported prevention concept

Standard of Care

Standard of Care according to currently valid guidelines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PräVaNet-Intervention

interdisciplinary and digitally supported prevention concept

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No