Early detection of health deterioration in elderly patients after hospitalization for heart failure: A potential role for home environmental sensor systems
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Autre
(BASEC)
Olten, Solothurn
(BASEC)
Sponsor
Solothurner Spitäler AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Benjamin Vögeli
061 265 44 44
benjamintobias.voegeli@clutterusb.chDepartment of Cardiology University Hospital Basel
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
20.12.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT06126848 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation (ICTRP)
Maladie en cours d'investigation
Heart Failure
(ICTRP)
Intervention étudiée
Device: Ambient sensor system
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Sensitivity and specificity of ambient sensor derived digital biomarkers
(ICTRP)
Outcome assessment
Quality of life (heart failure symptoms) - KCCQ
System Usability Scale (SUS)
(ICTRP)
Date d'enregistrement
06.11.2023 (ICTRP)
Inclusion du premier participant
01.01.2024 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
eHealth-HF (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06126848 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible