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

Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization Units (TROMBODOM/ADOMFIB Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Physical Inactivity; Thromboprophylaxis; Thromboembolism, Venous; Hospital at Home
• Intervention / Treatment: Device: Triaxial accelerometry

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.

• Study Type: Observational
• Enrollment (Estimated): 1953

Contacts and Locations

• Study Contact: Name: Joao Modesto dos Santos, Medical Doctor; Phone Number: 0034689208762; Email: jmodestosantos@gmail.com

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Hospital Universitario de Navarra
      • Contact: Joao Modesto dos Santos, Medical Doctor; Phone Number: 0034689208762

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with acute medical diseases (non-surgical setting) to either a conventional hospitalization unit or at home hospitalization units, whenever able to understand the study protocol and sign the informed consent form, will be offered to participate in this study. In patients' best interests, those with end-of-life disease, receiving palliative care or with an expected life survival inferior to 3 months will not be included. To correctly evaluate the study outcomes, patients receiving therapeutic doses of any anticoagulant drug, those with active diagnosis of thromboembolic disease or prior diagnosis of atrial fibrillation will not be included. Finally, this study excludes pregnant or breast-feeding people and patients with active or recent SARS-CoV2 infection, due to well recognized differences in the pathophysiology of thromboembolic disease in such populations.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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).
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.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated thrombotic risk at admission measured with Padua score	Estimated thrombotic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with Padua score (high or low risk). "Padua" score is a risk assessment model that scores from 0 to 20, with a score of 4 or higher identifying patients at "high risk" of thromboembolic disease.	Within 3 months after hospitalization
Estimated thrombotic risk at admission measured with IMPROVE-VTE score	Estimated thrombotic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with IMPROVE-VTE score (high or low risk). "IMPROVE-VTE" score is a risk assessment model that scores from 0 to 12, with a score of 2 or higher identifying patients at "high risk" of thromboembolic disease.	Within 3 months after hospitalization
Estimated hemorrhagic risk at admission	Estimated hemorrhagic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with IMPROVE-Bleeding score (high or low risk). "IMPROVE-Bleeding" score is a risk assessment model that scores from 0 to 33, with a score of 7 or higher identifying patients at "high risk" of hemorrhagic events.	Within 3 months after hospitalization
Incidence of thrombotic events	Incidence of thrombotic events (deep venous thrombosis and pulmonary embolism) of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units	Within 3 months after hospitalization
Incidence of atrial fibrillation diagnosis	Incidence of atrial fibrillation diagnosis in patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units	Within 3 months after hospitalization
Accelerometry	A GENEActiv watch will be used on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction. The results will be the duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity. All the outcomes may range from 1 to 1440 minutes per day.	The duration of the hospitalization, from 0,9 days to 9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of reduced mobility, measured with self-perceived immobilization	Self-perceived immobilization evaluated at admission with Padua score. "Padua" score is a risk assessment model that scores from 0 to 20, with a score of 4 or higher identifying patients at "high risk" of thromboembolic disease, and in which "reduced mobility" scores 3 points.	Baseline
Prevalence of reduced mobility, measured with accelerometry	Reduced mobility will be assessed in an objective determination with a GENEActiv watch. A GENEActive watch will be used on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction. The results will be the duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity. All the outcomes may range from 1 to 1440 minutes per day.	The duration of the hospitalization, from 0,9 days to 9 days
Concordance of self-perceived immobilization and objective accelerometry measurements of physical activity for reduced mobility identification	Reduced mobility can be assessed by subjective (e.g. self-perceived immobilization) or objective means (accelerometry). This outcome will determine the variability in identifying reduced mobility patients, when comparing reduced mobility assessed by subjective (self-perceived immobilization) or objective means (accelerometry)	At admission and during the duration of the hospitalization, from 0,9 days to 9 days
International Physical Activity Questionnaire (IPAQ)	The IPAQ is a validated 7-day recall questionnaire measuring current levels of physical activity. This questionnaire will be administered to participants aged under 65 years old. Scoring of the IPAQ results in a continuous variable in the form of total METs per week, which may be converted to METs per day. Higher scores means higher physical activity level. Additionally, walking, moderate physical activity and intense physical activity will be calculated as minutes per week. In addition, we will measure the change in physical activity levels from before hospitalization to three months later.	First day of hospitalization and 3 months after hospitalization
The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)	The VREM is a 6-item questionnaire that measures leisure time physical activity. It will be administered to people over 65 years of age. It reports energy expenditure over the past month expressed as 14-day METs. The number of METs per day will also be indicated. In addition, we will measure the change in physical activity levels from before hospitalization to three months later.	First day of hospitalization and 3 months after hospitalization
Handgrip strength	Muscle strength will be measured with a dynamometer and will be expressed in Kgs.	First (baseline) and last day of hospitalization (up to 9 days)
30-second sit-to-stand test	Participants under 65 years of age will repeat as many of the sit-to-stand actions as possible in 30 seconds and the maximum number completed will be recorded.	First (baseline) and last day of hospitalization (up to 9 days)
The Short Physical Performance Battery (SPPB)	Participants over the age of 65 will complete the SPPB, which consists of 3 tests: 1) a progressive test of standing balance, 2) a 4-meter usual pace walk, and 3) a five-repetition chair stand test. Each test has a minimum score of 0 points and a maximum of 4 points. Thus, the final SPPB score ranges from 0 to 12 points.	First (baseline) and last day of hospitalization (up to 9 days)
The Spanish Version of 5-level European Quality of Life-5 Dimensions (5-level EQ-5D)	The 5-level EQ-5D (EQ-5D-5L) is a generic standardized instrument that will be used to describe and assess the health-related quality of life of people over 65 years of age. The 5-level EQ-5D (EQ-5D-5L) instrument consists of two parts: the EQ-5D descriptive system and the Visual Analogue Scale (VAS). The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the VAS, the individual scores his or her health between two extremes, 0 being the worst imaginable state of health and 100 the best imaginable state of health.	First day of hospitalization (baseline)
Fried frailty criteria	Frailty in people older than 65 years will be assessed according to five criteria: unintentional weight loss, low mood, gait speed, level of physical activity and muscle weakness. The stages of frailty have been defined as follows: a score of 0 means that a person is robust or not frail, a score of 1 or 2 indicates a risk for adverse outcomes and is considered to pre-frailty and a score of 3-5 suggests that the person is frail.	First day of hospitalization (baseline)
Lobo's cognitive mini-examination	This questionnaire examines several cognitive dimensions: temporal orientation, spatial orientation, attention, concentration and calculation, memory and language and construction. In people over 65 years of age, scores of 23-24 are the cut-off point at which a diagnosis of dementia is established. A score between 20 and 24 indicates mild cognitive impairment. Values between 15 and 19 represent moderate cognitive impairment and a clear sign of the existence of dementia. Finally, a score below 15 points suggests severe cognitive impairment leading to advanced dementia.	First day of hospitalization (baseline)
Prevalence of pharmacological thromboprophylaxis use	Prevalence of pharmacological thromboprophylaxis (low molecular weight heparin) use during admission	Last day of hospitalization (up to 9 days)
Prevalence of correct pharmacological thromboprophylaxis use according to risk assessment models	Prevalence of correct pharmacological thromboprophylaxis (low molecular weight heparin) use during admission, evaluated according to Padua and IMPROVE-VTE score	Last day of hospitalization (up to 9 days)
Prevalence of correct pharmacological thromboprophylaxis use according to objective mobility evaluation with accelerometry	Prevalence of correct pharmacological thromboprophylaxis (low molecular weight heparin) use during admission, evaluated according to Padua and IMPROVE-VTE score when mobility is evaluated objectively with accelerometry	Last day of hospitalization (up to 9 days)

Collaborators and Investigators

• Sponsor: Universidad Pública de Navarra
• Collaborators: Sociedad Española De Medicina Interna; Daiichi Sankyo
• Investigators: Principal Investigator: Joao Modesto dos Santos, Medical Doctor, Hospital Universitario de Navarra, Spain

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Accelerometry; Thromboprophylaxis; Thromboembolism; Hospital at Home
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: PI_2021/100//PI_2022/91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No