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Clinical Trials/NCT05782075
NCT05782075Active, not recruitingNot Applicable

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

Hôpital NOVO1 site in 1 country100 target enrollmentStarted: February 23, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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,

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Assessment of the risk of death in the study population between discharge and M3(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)(At the end of the patient's follow-up, an average of 3 month)
  • Assessment of the risk of rehospitalisation in the study population between discharge and M3(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))(At the end of the patient's follow-up, an average of 3 month)
  • Assessment of the feasibility of the patient monitoring system(At the end of the patient's follow-up, an average of 3 month)

Investigators

Sponsor
Hôpital NOVO
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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