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Type 2 DiabetesPräVaNetNCT05887180

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

A study testing PräVaNet-Intervention in people with Type 2 Diabetes and Arteriosclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PräVaNet-Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
1 siteGermany
Study dates
1 Jan 2022to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Berlin, 12203

Other trials in Germany

About this study

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.

Read the 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.

Being tested
PräVaNet-Intervention
Keywords
E-Health, Telemedicine, Prevention
Medical subject headings
Diabetes Mellitus, Type 2, Arteriosclerosis, Hypertension, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PräVaNet-InterventionOther

    interdisciplinary and digitally supported prevention concept

Study groups in NCT05887180
Study groupRoleWhat they receive
PräVaNet-InterventionExperimentalInterdisciplinary 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.
Receives: Other: PräVaNet-Intervention
Standard of CareNo interventionStandard of Care according to currently valid guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 20 months

Secondary outcomes (13)

  1. 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.

    Measured: 20 months

  2. Complication rate

    e.g., atrial fibrillation, hypoglycemia, diabetic nephropathy

    Measured: 20 months

  3. 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

    Measured: 20 months

  4. 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.

    Measured: 20 months

  5. 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.

    Measured: 20 months

  6. 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.

    Measured: 20 months

  7. 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

    Measured: 20 months

  8. Inpatient health care utilization

    Measured by % of patients with hospitalizations/utilized inpatient health care services assessed by SHI data.

    Measured: 20 months

  9. Direct medical costs of intervention and control group patients

    Measured: 20 months

  10. Relative share of outpatient costs, inpatient costs and pharmaceutical costs in total direct medical costs

    Measured: 20 months

  11. Costs of work incapacity / early retirement of intervention and control group patients

    Measured: 20 months

  12. Incremental cost-effectiveness ratio (ICER) using the primary outcome measure (MACCE "Plus" events) as the effectiveness criterion (cost-effectiveness analysis)

    Measured: 20 months

  13. 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))

    Measured: 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start1 Jan 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomly assigned to 1 of 2 possible treatment arms (standard of care vs. intervention)
Masking
None (open label)
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887180
Sponsor's protocol ID
01NVF20001
Acronym
PräVaNet
Status last verified
Jun 2023
First submitted
5 Apr 2023
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PräVaNet-Intervention in people with Type 2 Diabetes and Arteriosclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of adverse cardiovascular and cerebrovascular events (MACCE "Plus" events) (time frame: 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05887180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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