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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arteriosclerosis; Type 2 Diabetes; Lipid Metabolism Disorders; Arterial Hypertension
• Intervention / Treatment: Other: PräVaNet-Intervention

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 Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: PräVaNet-Intervention; interdisciplinary and digitally supported prevention concept
No Intervention: Standard of Care; Standard of Care according to currently valid guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 months
Complication rate	e.g., atrial fibrillation, hypoglycemia, diabetic nephropathy	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	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.	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.	20 months
Changes in patient reported physical, psychological and social health	Changes in patient reported physical, psychological and social health by using the Patient-Reported Outcomes Measurement Information System (PROMIS®): pain intensity (0-10 numeric rating item) and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain, each measured on a likert scale of answers ranging from 1-5. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10. The higher the T-score points, the better the health status.	20 months
Changes in diabetes self-care activities	Changes in diabetes self-care activities, measured by the Diabetes Self-Management Questionnaire (DSMQ): scale min = 1; scale max = 4; higher scores mean better treatment behavior	20 months
Inpatient health care utilization	Measured by % of patients with hospitalizations/utilized inpatient health care services assessed by SHI data.	20 months
Relative share of outpatient costs, inpatient costs and pharmaceutical costs in total direct medical costs		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)	cost-utility analysis: incremental cost-utility ratio using health-related quality of life as utility (complemented by length of health state for calculation of quality-adjusted-life-years (QALYs))	20 months
Direct medical costs of intervention and control group patients		20 months
Costs of work incapacity / early retirement of intervention and control group patients		20 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Association of Statutory Health Insurance Physicians (KV Berlin); Statutory health insurance provider AOK Nordost; German Foundation for the Chronically ill (DScK); aQua - Institute for Applied Quality Improvement and Research in Health Care GmbH; Scientific Institute for Health Economics and Health System Research (WIG2)
• Investigators: Principal Investigator: David Sinning, MD, Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine

Publications and helpful links

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Prevention; E-Health
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Hypertension; Arteriosclerosis; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: 01NVF20001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No