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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes, Arteriosclerosis, Arterial Hypertension, Lipid Metabolism Disorders

Intervention / Treatment
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* Other: PräVaNet-Intervention


Participation Criteria
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Eligibility Criteria
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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: 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 macrovascular manifestations (coronary artery disease (CAD) and/or peripheral arterial disease (CAD) and/or carotid stenosis) and/or 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned to 1 of 2 possible treatment arms (standard of care vs. intervention)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PräVaNet-Intervention<br>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<br>* interdisciplinary and digitally supported prevention concept<br>|
| No Intervention: Standard of Care<br>Standard of Care according to currently valid guidelines. | |

What is the study measuring?
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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 | 
| Direct medical costs of intervention and control group patients |  | 20 months | 
| Relative share of outpatient costs, inpatient costs and pharmaceutical costs in total direct medical costs |  | 20 months | 
| Costs of work incapacity / early retirement of intervention and control group patients |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E-Health, Telemedicine, Prevention