Clinical trial NCT05887180: PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention
Official title: PräVaNet - Structured, Intersectoral, Multiprofessional, Digitized Program to Optimize Cardiovascular Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Arteriosclerosis
Arterial Hypertension
Lipid Metabolism Disorders
Keywords: E-Health
Telemedicine
Prevention
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Association of Statutory Health Insurance Physicians (KV Berlin)
name: Statutory health insurance provider AOK Nordost
name: German Foundation for the Chronically ill (DScK)
name: aQua - Institute for Applied Quality Improvement and Research in Health Care GmbH
name: Scientific Institute for Health Economics and Health System Research (WIG2)
First posted: 2023-06-02
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to 1 of 2 possible treatment arms (standard of care vs. intervention)
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: Rate of adverse cardiovascular and cerebrovascular events (MACCE "Plus" events)
timeFrame: 20 months
Secondary outcomes:
measure: Cardiovascular risk
timeFrame: 20 months
measure: Complication rate
timeFrame: 20 months
measure: Adherence to therapy
timeFrame: 20 months
measure: Changes in self-reported quality of life
timeFrame: 20 months
measure: Changes in patient reported quality of care
timeFrame: 20 months
measure: Changes in patient reported physical, psychological and social health
timeFrame: 20 months
measure: Changes in diabetes self-care activities
timeFrame: 20 months
measure: Inpatient health care utilization
timeFrame: 20 months
measure: Direct medical costs of intervention and control group patients
timeFrame: 20 months
measure: Relative share of outpatient costs, inpatient costs and pharmaceutical costs in total direct medical costs
timeFrame: 20 months
measure: Costs of work incapacity / early retirement of intervention and control group patients
timeFrame: 20 months
measure: Incremental cost-effectiveness ratio (ICER) using the primary outcome measure (MACCE "Plus" events) as the effectiveness criterion (cost-effectiveness analysis)
timeFrame: 20 months
measure: Incremental cost-utility relation (societal perspective)
timeFrame: 20 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine
Study officials:
affiliation: Deutsches Herzzentrum der Charité; Department of Cardiology, Angiology and Intensive Care Medicine
name: David Sinning, MD
role: PRINCIPAL_INVESTIGATOR
References: