Stop Sepsis Through Home Monitoring Cooperative

NCT ID: NCT06920979

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-12-31

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

(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.

Group Type: OTHER

(semi)continue monitoring of patients at risk for sepsis at home

Intervention Type: OTHER

(semi)continue monitoring of patients at risk for sepsis at home

Interventions

(semi)continue monitoring of patients at risk for sepsis at home

(semi)continue monitoring of patients at risk for sepsis at home

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Guy Hans

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Antwerp University Hospital (UZA)

Edegem, Antwerpen, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Celine Maes, PHD

Role: CONTACT

thuisopvolging@uza.be

+32 3 436 81 65

Facility Contacts

Guy H Hans, MD, PhD

Role: primary

thuisopvolging@uza.be

003238214945

Other Identifiers

Governement Health Belgium

Identifier Type: OTHER

Identifier Source: secondary_id

EDGE003963

Identifier Type: -

Identifier Source: org_study_id