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Biological Monitoring by a Nurse for Heart Failure Patients.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05782075
Acronym
IC-SPEC
Enrollment
100
Registered
2023-03-23
Start date
2023-02-23
Completion date
2025-04-30
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Biological monitoring, Heart failure nurse, Post-hospitalization

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.

Interventions

OTHERRemote biological monitoring by a heart failure nurse

Review of biological results by a nurse (IDE) trained in heart failure monitoring, alongside the cardiologist, at S1, S2, M1, M2 and M3.

Sponsors

Hôpital NOVO
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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,

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failureAt the end of the patient's follow-up, an average of 3 monthThe 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

MeasureTime frameDescription
Assessment of the risk of rehospitalisation in the study population between discharge and M3At the end of the patient's follow-up, an average of 3 monthThe 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.
Assessment of the risk of death in the study population between discharge and M3At the end of the patient's follow-up, an average of 3 monthThe 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.
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 monthThe 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,
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 monthThe 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.
Assessment of the feasibility of the patient monitoring systemAt the end of the patient's follow-up, an average of 3 monthThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026