Investigation of a Novel Integrated Care Concept (NICC) for Patients Suffering From Chronic Cardiovascular Disease

Summary

Cardiovascular diseases are the number 1 cause of death globally and represent a major economic burden on health care systems. The investigators have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a call center, an integrated care network including in- and outpatient care providers and guideline therapy for patients with heart failure (HF), atrial fibrillation (AF) or therapy resistant hypertension (TRH). The aim of the study is to show that NICC is preferable over guideline therapy alone. We aim at including approximately 890 patients. Patients could be enrolled either directly at the Care-Center (location: University Hospital of Rostock) or at one of the advanced treatments rooms of the Care-Center (outpatient cardiological specialist practices).

The ethics commission's statement of the University of Rostock is available for amendment 2 since 20.08.2019 at the number A2017-0117.

Conditions

• Heart Failure
• Atrial Fibrillation
• Treatment Resistant Hypertension

Interventions

OTHER

Novel integrated care concept (NICC)

Integrated care concept including, e.g., call center, guideline therapy, tablet and medical devices

OTHER

Standard care

Guideline therapy according to the guidelines of the European Society of Cardiology (ESC).

Sponsors & Collaborators

• AOK Nordwest

  collaborator INDUSTRY

• Techniker Krankenkasse

  collaborator OTHER

• Philips GmbH Market DACH

  collaborator UNKNOWN

• AMEDON GmbH

  collaborator UNKNOWN

• Lohfert & Lohfert AG

  collaborator UNKNOWN

• Society for Network & Innovation Management of Industry (Germany)

  collaborator OTHER

• Gemeinsamer Bundesausschuss

  collaborator UNKNOWN

• Universitätsmedizin Rostock Versorgungsstrukturen GmbH

  collaborator UNKNOWN

• University Medical Center Rostock

  lead OTHER

Principal Investigators

• Christian Schmidt, Prof Dr · Universitätsmedizin Rostock

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2020-09-30

Completion

2020-09-30

Countries

• Germany

Study Locations