Early detection of health deterioration in elderly patients after hospitalization for heart failure: A potential role for home environmental sensor systems
Descrizione riassuntiva dello studio
The study investigates the accuracy of a comprehensive remote monitoring and treatment program. For the study, patients are equipped with a remote monitoring system capable of monitoring health status. For this purpose, the sensors measure movement within the living environment. Additionally, we measure heart activity, breathing, and movement during sleep. If there are signs of health deterioration, the system will alert us, and we will contact you. The aim of the study is to find out whether the system reliably and early detects deteriorations in health status related to heart failure.
(BASEC)
Intervento studiato
This study involves monitoring the frequency of daily activities at home using environmental sensors that detect movements. Furthermore, the sleep cycle, pulse, and breathing during sleep are monitored with a sensor installed under the mattress. This sensor system has provided promising data in the past to detect health deteriorations early. After hospitalization, the sensor system will be installed at the participants' homes within 3 - 5 days after discharge from the hospital. This will continuously transmit data about daytime activity at home and the participants' sleep. In case of abnormalities or significant changes in these recordings, we will contact the participants by phone to inquire about their well-being and schedule them for a physical examination and blood test at the hospital.
(BASEC)
Malattie studiate
Heart failure
(BASEC)
- Age ≥ 70 years - Hospitalization due to heart failure (heart failure) - Left ventricular ejection fraction ≤ 50% and treatment with diuretics - Heart failure symptoms of NYHA class II - III - Willingness to participate in the study - Willingness to return to the hospital after 3 and 6 months (BASEC)
Criteri di esclusione
- Living in a multi-person household - No consent for participation in the study - Severe depression (PHQ9 score > 9) - Hemodialysis - Hospital admission within the last 7 days for any reason - Left ventricular assist device (LVAD) - Coronary revascularization or implantation of a cardiac resynchronization pacemaker within 28 days prior to hospital admission or planning such interventions (BASEC)
Luogo dello studio
Altro
(BASEC)
Olten, Solothurn
(BASEC)
Sponsor
Solothurner Spitäler AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Benjamin Vögeli
061 265 44 44
benjamintobias.voegeli@clutterusb.chDepartment of Cardiology University Hospital Basel
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
20.12.2023
(BASEC)
ID di studio ICTRP
NCT06126848 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Early Detection of Health Deterioration in Elderly Patients after Hospitalization for Heart Failure Decompensation: A potential Role for Ambient Sensor Systems in the Patients Home (BASEC)
Titolo accademico
Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation: A Potential Role for Ambient Sensor Systems in the Patients Home (ICTRP)
Titolo pubblico
Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation (ICTRP)
Malattie studiate
Heart Failure
(ICTRP)
Intervento studiato
Device: Ambient sensor system
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- admitted to hospital for worsening HF
- age = 70 years
- LVEF < 50% and need of diuretics
- NYHA II or III
- living alone
- willing to participate with informed consent.
Exclusion Criteria:
- Major depression (PHQ 9-score >9)
- being on hemodialysis
- had been admitted to hospital for any reason within 7 days before HF decompensation.
- patients with a left ventricular assist device
- coronary revascularization or cardiac resynchronization therapy implantation within 28
days before the index event of HF decompensation or have been scheduled for such
interventions.
(ICTRP)
non disponibile
Endpoint primari e secondari
Sensitivity and specificity of ambient sensor derived digital biomarkers
(ICTRP)
Outcome assessment
Quality of life (heart failure symptoms) - KCCQ
System Usability Scale (SUS)
(ICTRP)
Data di registrazione
06.11.2023 (ICTRP)
Inclusione del primo partecipante
01.01.2024 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
eHealth-HF (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06126848 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile