SepsisStethoscoopNCT06920979
Stop Sepsis Through Home Monitoring Cooperative
A study testing (semi)continue monitoring of patients at risk for sepsis at home in people with Sepsis and Home Monitoring Follow-up, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Home Monitoring Follow-up, Infection
- What is being tested?
- (semi)continue monitoring of patients at risk for sepsis at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2025to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital (UZA)
Edegem, Antwerpen, 2650
Guy H Hans, MD, PhD, 003238214945, thuisopvolging@uza.be
About this study
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.
- Conditions
- Sepsis, Home Monitoring Follow-up, Infection, Innovativeness
- Being tested
- (semi)continue monitoring of patients at risk for sepsis at home
- Medical subject headings
- Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(semi)continue monitoring of patients at risk for sepsis at homeOther
(semi)continue monitoring of patients at risk for sepsis at home
| Study group | Role | What they receive |
|---|---|---|
| (semi)continue monitoring of patients at risk for sepsis at home | Other | 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. Receives: Other: (semi)continue monitoring of patients at risk for sepsis at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Hans, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920979
- Sponsor's protocol ID
- EDGE003963
- Other IDs
- Governement Health Belgium
- Acronym
- Stethoscoop
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be published in a research paper in a scientific journal.