ThromboprophylaxisTROMBODOMNCT06110949
Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization
An observational study of Thromboprophylaxis and Thromboembolism, Venous, run by Universidad Pública de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboprophylaxis, Thromboembolism, Venous, Atrial Fibrillation
- What is being tested?
- Triaxial accelerometry
- Type of treatment
- Medical device
- How many people
- 1,953 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to Mar 2025
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Joao Modesto dos Santos, Medical Doctor, 0034689208762
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Triaxial accelerometry
- Keywords
- Thromboprophylaxis, Thromboembolism, Atrial Fibrillation, Accelerometry, Hospital at Home
- Medical subject headings
- Venous Thromboembolism, Atrial Fibrillation, Sedentary Behavior, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triaxial accelerometryDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Triaxial accelerometry | |
| 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. Receives: Device: Triaxial accelerometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: The duration of the hospitalization, from 0,9 days to 9 days
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First day of hospitalization (baseline)
Prevalence of pharmacological thromboprophylaxis use
Prevalence of pharmacological thromboprophylaxis (low molecular weight heparin) use during admission
Measured: 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
Measured: 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
Measured: Last day of hospitalization (up to 9 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Mar 2023
- Primary completion31 Jan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboprophylaxisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,953 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española De Medicina Interna, Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Joao Modesto dos Santos, Medical Doctor, Principal investigator, Hospital Universitario de Navarra, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110949
- Sponsor's protocol ID
- PI_2021/100//PI_2022/91
- Acronym
- TROMBODOM
- Status last verified
- May 2024
- First submitted
- 31 Aug 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization Units (TROMBODOM/ADOMFIB Study)
- ClinicalTrials.gov ID
- NCT06110949
- Acronym / sponsor ID
- TROMBODOM / PI_2021/100//PI_2022/91
- Conditions
- Thromboprophylaxis, Thromboembolism, Venous, Atrial Fibrillation, Physical Inactivity, Hospital at Home
- Keywords
- Thromboprophylaxis, Thromboembolism, Atrial Fibrillation, Accelerometry, Hospital at Home
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,953 participants (estimated)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Collaborators
- Sociedad Española De Medicina Interna, Daiichi Sankyo
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At home hospitalization cohort | – | Device: Triaxial accelerometryParticipants 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. |
| Conventional hospitalization cohort | – | Device: Triaxial accelerometryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triaxial accelerometryA 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). | Device | At home hospitalization cohort, Conventional hospitalization cohort |
Primary outcome
Estimated thrombotic risk at admission measured with Padua score
Time frame: Within 3 months after hospitalization
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.
Estimated thrombotic risk at admission measured with IMPROVE-VTE score
Time frame: Within 3 months after hospitalization
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.
Estimated hemorrhagic risk at admission
Time frame: Within 3 months after hospitalization
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.
Incidence of thrombotic events
Time frame: Within 3 months after hospitalization
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
Incidence of atrial fibrillation diagnosis
Time frame: Within 3 months after hospitalization
Incidence of atrial fibrillation diagnosis in patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units
Accelerometry
Time frame: The duration of the hospitalization, from 0,9 days to 9 days
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.
14 secondary outcomes
Prevalence of reduced mobility, measured with self-perceived immobilization
Time frame: Baseline
Prevalence of reduced mobility, measured with accelerometry
Time frame: 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
Time frame: At admission and during the duration of the hospitalization, from 0,9 days to 9 days
International Physical Activity Questionnaire (IPAQ)
Time frame: First day of hospitalization and 3 months after hospitalization
The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)
Time frame: First day of hospitalization and 3 months after hospitalization
Handgrip strength
Time frame: First (baseline) and last day of hospitalization (up to 9 days)
30-second sit-to-stand test
Time frame: First (baseline) and last day of hospitalization (up to 9 days)
The Short Physical Performance Battery (SPPB)
Time frame: 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)
Time frame: First day of hospitalization (baseline)
Fried frailty criteria
Time frame: First day of hospitalization (baseline)
Lobo's cognitive mini-examination
Time frame: First day of hospitalization (baseline)
Prevalence of pharmacological thromboprophylaxis use
Time frame: Last day of hospitalization (up to 9 days)
Prevalence of correct pharmacological thromboprophylaxis use according to risk assessment models
Time frame: Last day of hospitalization (up to 9 days)
Prevalence of correct pharmacological thromboprophylaxis use according to objective mobility evaluation with accelerometry
Time frame: Last day of hospitalization (up to 9 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joao Modesto dos Santos, Medical Doctor principal investigator
Hospital Universitario de Navarra, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboprophylaxis and Thromboembolism, Venous, run by Universidad Pública de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joao Modesto dos Santos, Medical Doctor (0034689208762, jmodestosantos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated thrombotic risk at admission measured with Padua score (time frame: Within 3 months after hospitalization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.