Early detection of health deterioration in elderly patients after hospitalization for heart failure: A potential role for home environmental sensor systems
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Andere
(BASEC)
Olten, Solothurn
(BASEC)
Sponsor
Solothurner Spitäler AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. Benjamin Vögeli
061 265 44 44
benjamintobias.voegeli@clutterusb.chDepartment of Cardiology University Hospital Basel
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.12.2023
(BASEC)
ICTRP Studien-ID
NCT06126848 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation (ICTRP)
Untersuchte Krankheit(en)
Heart Failure
(ICTRP)
Untersuchte Intervention
Device: Ambient sensor system
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Sensitivity and specificity of ambient sensor derived digital biomarkers
(ICTRP)
Outcome assessment
Quality of life (heart failure symptoms) - KCCQ
System Usability Scale (SUS)
(ICTRP)
Registrierungsdatum
06.11.2023 (ICTRP)
Einschluss des ersten Teilnehmers
01.01.2024 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
eHealth-HF (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06126848 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar