Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations (e-INCA)

May 18, 2017 updated by: University Hospital, Strasbourg, France

Anticipation and Detection of Heart Failure Decompensation With Automatic Treatment of Informations Derived From Non Intrusive Sensors and Devices

Heart failure (HF) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. The management of HF is complex: long, often difficult and costly. In France, nearly one million people suffer from HF and 120,000 new cases are diagnosed every year. With the aging population, this number will continue to evolve and become a real public health problem. Within 10 to 20 years ahead, WHO projects that heart failure in either the 3 most common diseases in industrialized countries.

The objective of the project is to test an intelligent platform for monitoring at home, using non-intrusive sensors, patients with heart failure, particularly those with stage II and III NYHA. It will assist the medical automating the processing of information from these sensors to detect and report an early stage risk situations.

Patient monitoring, by a system of telemedicine tools associated with motivation and education helps significantly reduce the number of days of hospitalization becomes important when the patient is hospitalized for acute HF.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Médecine Interne, diabète et maladies métaboliques - Médicale B
        • Contact:
        • Principal Investigator:
          • Emmanuel ANDRES, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population with heart failure stage II and III

Description

Inclusion Criteria:

  • Population with heart failure stage II and III

Exclusion Criteria:

  • Population whose age is less than 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Groupe 1: experimental group
Equiped group with telemedicine systems
Other: Equiped group with telemedicine systems
Groupe 2: control group
Non equiped group with telemedicine systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anticipation and detection of heart failure with automatic treatment of information derived from non intrusive sensors and devices
Time Frame: patient's medical data will be controlled remotely by health professional for the duration of hospital stay, up to 1 year]
patient's medical data will be controlled remotely by health professional for the duration of hospital stay, up to 1 year]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: ANDRES Emmanuel, MD, PhD, Strasbourg University Hospital, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Actual)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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