New Model of Care in Heart Failure

Summary

Heart failure (HF) is characterized by high mortality, poor quality of life and frequent hospitalizations. The effectiveness of out-patient care for HF patients is unsatisfactory. Therefore the solutions that enable effective monitoring and assessment of HF patients' clinical status become priority in treatment strategy. The applicant proposes to develop a model of care for HF patients based on modern non-invasive diagnostic tools and telemedicine. Clinical evaluation will be based on i.e. impedance cardiography, a simple non-invasive method of hemodynamic monitoring, including assessment of heart rate, blood pressure, left ventricular stroke volume, chest and total fluid status. The telemedicine system will enable rapid, appropriate to the patient's clinical status, therapeutic decision undertaken remotely by specialist. Implementation of the proposed model of care will contribute to a significant improvement in prognosis of HF patients (through i.e. improved access to specialist consultation, the early diagnosis of the deterioration of HF and the optimization of treatment). The significant economic, social and scientific benefits related to the project are also expected.

Conditions

• Heart Failure

Interventions

PROCEDURE

new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine

The report of symptoms and physical examination will be obligatory performed by the ACP nurse. Self-condition and quality of life assessment at every visit will be based on EQ-5D questionnaire and VAS 10-points scale Hemodynamic assessment - the ACP nurse will perform impedance cardiography (cardiomonitor) and bioimpedance (scale). The parameters measured by ICG and bioimpedance will be assessed with respect to individually defined target values for: heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), thoracic fluid content (TFC) and its change (delta TFC), change of body mass and total body water (delta TBW). Supervising physician will confront ICG/bioimpedance results with the patient's clinical data and give final remote recommendations.

Sponsors & Collaborators

• Wroclaw Medical University

  collaborator OTHER

• 4th Military Clinical Hospital with Polyclinic, Poland

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Military University of Technology

  collaborator UNKNOWN

• Military Institute od Medicine National Research Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-05

Primary Completion

2020-10-31

Completion

2021-03-30

Countries

• Poland

Study Locations