Stop Sepsis Through Home Monitoring Cooperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
In this study, patients presenting with acute infections at risk of developing sepsis will be followed in their home setting using wearables that provide (semi-)continue monitoring of vital signs as well as through follow up using a designated smartphone application. This is an innovative pilot study that will examine the potential of transmural care through telemonitoring for the first time in patients at risk for developing sepsis. By allowing for active follow-up of vital parameters in a transmural setting, this project aims to reduce the number of hospitalizations as compared to current practice. Furthermore, we aim to the number of patients referred to the emergency department after a visit at their primary care physician. Thereby, we aim to reduce the healthcare burden, yet providing the ability for rapid intervention in case of detarioration of patients, thereby reducing morbidity and mortality as well as associated costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
This study will include patients aged 18 years or older, capable of giving informed consent, presenting with signs of severe acute infection with a risk of developing sepsis at the emergency department or at their primary care physician.
Disqualifiers
Patients that are severely ill and require immediate hospitalization Qucik Sepsis Related Organ Failure score (QSOFA) ≥ 1 National Early Warning Score (NEWS) ≥ 5
Patients that demonstrate confusion, changes in mental state and/or an Mini-Mental State Examination (MMSE) below 26
Presence of neuropenic fever
Patients currently undergoing immunosuppressive therapy or chemotherapy
Trial design
Design model
Single group
Treatments tested in this trial
(semi)continue monitoring of patients at risk for sepsis at home
Other intervention(semi)continue monitoring of patients at risk for sepsis at home
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: (semi)continue monitoring of patients at risk for sepsis at homeOther 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the development and roll out of a central medical center for monitoring at home
The total number of patients who use the home monitoring system for at least three days. This measure evaluates the adoption and feasibility of remote monitoring within a real-world setting.
Time frame
From enrollment to the end of monitoring depending on the clinical evolution of the patient, with a minimum of one week and a maximum follow-up of three weeks.2
Evaluation of the development and roll out of a central medical center for monitoring at home
The proportion of patients whose wearable devices and smartphone applications successfully capture at least 80% of the required physiological data over the home monitoring period. This assesses the reliability and consistency of the telemonitoring system.
Time frame
From enrollment to the end of monitoring depending on the clinical evolution of the patient with a minimum follow-up of one week and up to a maximum of three weeks.3
Evaluation of the development and roll out of a central medical center for monitoring at home
The effectiveness of telemonitoring wearables and smartphone applications in accurately measuring and tracking the National Early Warning Score (NEWS) in a home setting. This evaluates the clinical utility of remote patient monitoring for early detection of health deterioration.
Time frame
From enrollment to the end of monitoring depending on the clinical evolution of the patient with a minimum follow-up of one week and up to a maximum of three weeks of follow-up.4
Evaluation of the development and roll out of a central medical center for monitoring at home
The number of emergency departments and primary care physicians actively using the telemonitoring platform to access and review patient data. This assesses the level of integration of home monitoring into routine clinical workflows.
Time frame
From enrollment to the end of monitoring depending on the clinical evolution of the patient with a minimum follow-up of one week and up to a maximum of three weeks of follow-up.Sponsors and contacts
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Source ClinicalTrials.gov