Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization

NCT ID: NCT06110949

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1953 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-31

Brief Summary

The thromboembolic disease is a common complication of patients admitted to conventional hospitalization units. To prevent such complications, thromboprophylaxis is indicated in high-risk patients identified with validated risk-assessment models such as Padua score and IMPROVE-VTE score. However, the relation between thromboembolic disease and inpatients is yet to be demonstrated in new clinical settings such as at home hospitalization units. Moreover, patient immobilization is key in the pathogenesis of thromboembolic complications: therefore, it is crucial to collect raw data of patient mobility during admission.

The goal of this observational study is to compare the thromboembolic risk of patients admitted with acute medical diseases to at home hospitalization units with conventional hospitalization units.

The main questions it aims to answer are:

• Is the estimated thromboembolic risk of patients admitted with acute medical diseases to at home hospitalization units similar to those admitted to conventional hospitalization units?
• Are the risk-assessment models used to predict thromboembolic risk of patients admitted with acute medical diseases to conventional hospitalization units (Padua and IMPROVE-VTE score) valid in at home hospitalization patients?

Participants admitted with acute medical diseases to either a conventional hospitalization unit or at home hospitalization units will be included in a prospective registry in order to investigate the 90 days incidence of thromboembolic disease. A cohort of such patients will be controlled with triaxial accelerometer in order to collect raw data regarding patient mobility during admission.

Detailed Description

1953 patients will be recruited (1700 in at home hospitalization units and 253 in conventional hospitalization units). All patients must accept and sign the informed consent. After being admitted to the study, patients will be included in the prospective registry with baseline evaluation of basic clinical data, including risk-assessment models (Padua and IMPROVE-VTE scores), examination, ECG, self-assessed mobility, and biochemistry markers. Triaxial accelerometers will also record mobility and sleep time of 135 patients from conventional hospitalization units and 135 patients from at home hospitalization units, from which physical activity questionnaires (International Physical Activity Questionnaire (IPAQ), The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)), handgrip strength, 30-second sit-to-stand test, the Short Physical Performance Battery (SPPB), the Spanish Version of 5-level European Quality of Life-5 Dimensions (5-level EQ-5D), Fried frailty criteria and Lobo's cognitive mini-examination will also be obtained. All 1953 patients will be followed for 90 days after discharge to assess thromboembolic disease incidence (pulmonary embolism, deep venous thrombosis, and atrial fibrillation), major and clinically relevant non-major bleedings (according to International Society on Thrombosis and Haemostasis Standards) and death.

Conditions

Thromboprophylaxis; Thromboembolism, Venous; Atrial Fibrillation; Physical Inactivity; Hospital at Home

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

At home hospitalization cohort

Participants admitted with acute medical diseases to at home hospitalization units will be included in a prospective registry in order to investigate the 90 days incidence of thromboembolic disease. A group of such patients will be controlled with triaxial accelerometer in order to collect raw data regarding patient mobility during admission.

Triaxial accelerometry

Intervention Type: DEVICE

A group of patients will be controlled with triaxial accelerometer (GENEActiv watch) on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction, in order to collect raw data regarding patient mobility (duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity) during the admission (from the admission day to discharge).

Conventional hospitalization cohort

Participants admitted with acute medical diseases to a conventional hospitalization unit will be included in a prospective registry in order to investigate the 90 days incidence of thromboembolic disease. A group of such patients will be controlled with triaxial accelerometer in order to collect raw data regarding patient mobility during admission.

Triaxial accelerometry

Intervention Type: DEVICE

A group of patients will be controlled with triaxial accelerometer (GENEActiv watch) on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction, in order to collect raw data regarding patient mobility (duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity) during the admission (from the admission day to discharge).

Interventions

Triaxial accelerometry

A group of patients will be controlled with triaxial accelerometer (GENEActiv watch) on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction, in order to collect raw data regarding patient mobility (duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity) during the admission (from the admission day to discharge).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Patients admitted with acute medical diseases to either a conventional hospitalization unit or at home hospitalization units
• Capable and willing to provide an informed consent

Exclusion Criteria

• End of life disease, palliative care or with an expected survival inferior to 3 months
• Patients receiving therapeutic doses of any anticoagulant drug
• Active diagnosis of thromboembolic disease
• Prior diagnosis of atrial fibrillation
• Pregnancy or breast-feeding.
• SARS-CoV-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (PCR) tests or positive for SARS-CoV-2 virus antigen <90 days before randomization.

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

Sponsors

Sociedad Española De Medicina Interna

OTHER

Sponsor Role: collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

Universidad Pública de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joao Modesto dos Santos, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Navarra, Spain

Locations

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Joao Modesto dos Santos, Medical Doctor

Role: CONTACT

jmodestosantos@gmail.com

0034689208762

Facility Contacts

Joao Modesto dos Santos, Medical Doctor

Role: primary

0034689208762

Other Identifiers

PI_2021/100//PI_2022/91

Identifier Type: -

Identifier Source: org_study_id