Stop Sepsis Through Home Monitoring Cooperative (Stethoscoop)

April 27, 2026 updated by: Guy Hans, University Hospital, Antwerp
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital (UZA)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the development and roll out of a central medical center for monitoring at home
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.
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
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.
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
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.
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
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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