Clinical trial NCT05782075: Biological Monitoring by a Nurse for Heart Failure Patients.
Official title: Biological Monitoring by a Nurse of Post-hospital Heart Failure Patients.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Keywords: Heart failure
Biological monitoring
Heart failure nurse
Post-hospitalization
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients discharged from the cardiology department of NOVO Hospital with a heart failure episode

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Assessment of the concordance, appropriateness and safety of nursing decisions in post-hospitalization heart failure
timeFrame: At the end of the patient's follow-up, an average of 3 month
Secondary outcomes:
measure: Assessment of the risk of rehospitalisation in the study population between discharge and M3
timeFrame: At the end of the patient's follow-up, an average of 3 month
measure: Assessment of the risk of death in the study population between discharge and M3
timeFrame: At the end of the patient's follow-up, an average of 3 month
measure: Impact of the organisation on patient outcomes at M3 (Brain natriuretic peptide)
timeFrame: At the end of the patient's follow-up, an average of 3 month
measure: Impact of the organisation on patient outcomes at M3 (New York Heart Association (NYHA))
timeFrame: At the end of the patient's follow-up, an average of 3 month
measure: Assessment of the feasibility of the patient monitoring system
timeFrame: At the end of the patient's follow-up, an average of 3 month
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Cardiology department - Hospital NOVO - Pontoise site
Study officials:
affiliation: Hospital NOVO - Pontoise site
name: Morgane Gessat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.
citation: Khan MS, Sreenivasan J, Lateef N, Abougergi MS, Greene SJ, Ahmad T, Anker SD, Fonarow GC, Butler J. Trends in 30- and 90-Day Readmission Rates for Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e008335. doi: 10.1161/CIRCHEARTFAILURE.121.008335. Epub 2021 Apr 19.
citation: Health Quality Ontario. Effect of Early Follow-Up After Hospital Discharge on Outcomes in Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: A Systematic Review. Ont Health Technol Assess Ser. 2017 May 25;17(8):1-37. eCollection 2017.
citation: Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Kim SS, Koehler K, Lucke S, Honold M, Heinze P, Schweizer T, Braecklein M, Kirwan BA, Gelbrich G, Anker SD; TIM-HF Investigators. Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Eur J Heart Fail. 2010 Dec;12(12):1354-62. doi: 10.1093/eurjhf/hfq199.
citation: Jourdain P, Jondeau G, Funck F, Gueffet P, Le Helloco A, Donal E, Aupetit JF, Aumont MC, Galinier M, Eicher JC, Cohen-Solal A, Juilliere Y. Plasma brain natriuretic peptide-guided therapy to improve outcome in heart failure: the STARS-BNP Multicenter Study. J Am Coll Cardiol. 2007 Apr 24;49(16):1733-9. doi: 10.1016/j.jacc.2006.10.081. Epub 2007 Apr 2.