Stop Sepsis Through Home Monitoring Cooperative (Stethoscoop)

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Infection; Home Monitoring Follow-up; Innovativeness
• Intervention / Treatment: Other: (semi)continue monitoring of patients at risk for sepsis at home

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celine Maes, PHD; Phone Number: +32 3 436 81 65; Email: thuisopvolging@uza.be

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital (UZA)
      • Contact: Guy H Hans, MD, PhD; Phone Number: 003238214945; Email: thuisopvolging@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Patients with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)
• Suspicion of appendicitis, suspicion of meningitis or meningeal irritation, suspicion of or high risk of developing endocarditis
• Complicated operation wounds at the time of screening
• Proven pneumonia (CURB 65 score ≥ 1)
• Emphysema, Chronic Obstructive Pulmonary Disease (COPD) GOLD >1 or interstitial lung disease
• Patients with oxygen at home > 2 l/min on a chronic basis (severe underlying lung disease?)

• Severe cardiovascular disease including:

  • Severe heart failure New York Heart Association (NYHA) class > 1
  • Endoprosthesis
  • Cardiac arrhythmia including atrial fibrillation
  • Severe heart valve abnormalities
  • Mechanic valve replacement
  • Recent acute myocardial infarct or coronarography (less than 1y ago)
  • Severe peripheral vascular morbidity
• Acute chest pain (suspicion of acute coronary pathology)
• Suspicion of/chance of septic arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: (semi)continue monitoring of patients at risk for sepsis at home; Patients with acute infections at risk of developing sespsis 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 desingated smarthphone application.	Other: (semi)continue monitoring of patients at risk for sepsis at home; (semi)continue monitoring of patients at risk for sepsis at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.
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.	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.
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.	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.

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Infections
• Other Study ID Numbers: EDGE003963; Governement Health Belgium (Other Identifier: Stethoscoop federal governement heatlh Belgium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results will be published in a research paper in a scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No