Biological Monitoring by a Nurse for Heart Failure Patients. (IC-SPEC)

December 30, 2024 updated by: Hôpital NOVO

Biological Monitoring by a Nurse of Post-hospital Heart Failure Patients.

The aim of this study is to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic heart failure is a major public health issue in France. It is the leading cause of hospitalisation in people over 65 years of age and results in many costly and potentially avoidable hospital stays. One third of patients are readmitted to hospital within 3 months of discharge.

A remote monitoring programme and natriuretic peptide monitoring during this vulnerable period can help improve patient management, reducing rehospitalisation rates, emergency room visits and mortality.

Given the increasing pressure on already limited healthcare resources, it is important to examine the delegation of care to specialist nurses, as well as their safety.

This study aims to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

Study Type

Observational

Enrollment (Actual)

100

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
      • Pontoise, France, 95300
        • Cardiology department - Hospital NOVO - Pontoise site

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

Sampling Method

Non-Probability Sample

Study Population

Patients discharged from the cardiology department of NOVO Hospital with a heart failure episode

Description

Inclusion Criteria:

  • Patient ≥18 years old,
  • Patient hospitalised for heart failure and discharged,
  • Glomerular filtration rate at discharge > 20ml/min/1.73m²,
  • Patient informed and agree to participate,
  • Patient able to carry out the follow-up proposed by the cardiology department.

Exclusion Criteria:

  • Cognitive disorders with Codex test category C and D,
  • Barrier of the language,
  • Psychiatric disorder that may interfere with treatment,
  • Major surgery scheduled within 3 months,
  • Excessive alcohol or drug use with no desire to withdraw
  • Cardiac amyloidosis,
  • Terminal heart failure,
  • Patient discharged to specialised Care and Rehabilitation department,
  • Any disease other than cardiac with a life expectancy of less than 1 year according to the investigator,
  • Patient under guardianship,

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure
Time Frame: At the end of the patient's follow-up, an average of 3 month
The relevance and safety of IDE decisions will be determined by the concordance rate between the decisions made by the cardiologist and the IDE following the biological results at each check-up and after blind review by a second cardiologist
At the end of the patient's follow-up, an average of 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the risk of rehospitalisation in the study population between discharge and M3
Time Frame: At the end of the patient's follow-up, an average of 3 month

The risk of rehospitalization and death will be assessed, to see if a significant difference is observed between IDE decisions and cardiologist decisions, with items listed below :

  • Number of interventions initiated,
  • Number of rehospitalisation for all causes and for heart failure.
  • Number of emergency room visits for heart failure and all causes.
At the end of the patient's follow-up, an average of 3 month
Assessment of the risk of death in the study population between discharge and M3
Time Frame: At the end of the patient's follow-up, an average of 3 month
The risk of death will be assessed by the rate of death for all-cause and cardiac to see if a significant difference is observed between IDE decisions and cardiologist decisions.
At the end of the patient's follow-up, an average of 3 month
Impact of the organisation on patient outcomes at M3 (Brain natriuretic peptide)
Time Frame: At the end of the patient's follow-up, an average of 3 month

The impact of the organisation, favourable or unfavourable, on patient outcomes will be assessed by the evolution of the following item :

- Brain natriuretic peptide levels between discharge and three months,
At the end of the patient's follow-up, an average of 3 month
Impact of the organisation on patient outcomes at M3 (New York Heart Association (NYHA))
Time Frame: At the end of the patient's follow-up, an average of 3 month

The impact of the organisation, favourable or unfavourable, on patient outcomes will be assessed by the evolution of the following item :

- New York Heart Association (NYHA) score from discharge to three months.
At the end of the patient's follow-up, an average of 3 month
Assessment of the feasibility of the patient monitoring system
Time Frame: At the end of the patient's follow-up, an average of 3 month

The feasibility of the patient monitoring system will be assessed in relation to the number of biological tests not performed.

If the number of biological tests not performed is too high, the patient monitoring system will not be validated.
At the end of the patient's follow-up, an average of 3 month

Collaborators and Investigators

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

Sponsor

Hôpital NOVO

Investigators

  • Principal Investigator: Morgane Gessat, Hospital NOVO - Pontoise site

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 23, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD0323

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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