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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03025100
Other study ID # Pro00056253
Secondary ID R03AG048007-01
Status Completed
Phase
First received
Last updated
Start date February 2016
Est. completion date March 4, 2017

Study information

Verified date October 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Guideline directed use of pharmacologic Venous thromboembolism (VTE) prophylaxis emphasizes mobility evaluation. Mobility is a key component of risk stratification. Poor mobility evaluation by providers may be a significant barrier to appropriate use of VTE prophylaxis. The investigators aim is to propose to determine whether level of mobility during hospitalization is being used to influence use and duration of VTE prophylaxis among medically ill hospitalized elders. To achieve this aim, the investigator will collect prospective observational data to objectively measure inpatient mobility using patient mounted accelerometers during patient hospital stays. The investigator's goal is to improve the appropriateness of use of VTE prophylaxis among those in which the risks of harm may outweigh the benefit. Results from this study will provide important insights about use of risk assessment, and the relationship between patient mobility and VTE prophylaxis. These results are critical to understanding how to take the next steps toward improving the appropriate use and safety of anticoagulants in hospitalized older adults. Information from this study could be used in future proposals to study interventions to ultimately improve hospital practice in the care of older adults.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date March 4, 2017
Est. primary completion date March 4, 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: 1. Age of 60 or older 2. Admitted to General Medicine at Duke University Exclusion Criteria: 1. Clear contraindications to pharmacologic VTE prophylaxis 2. Receiving surgery during their index hospital stay 3. On observation admission status 4. On negative pressure room respiratory isolation 5. Wrist site is not available, i.e. wearing bilateral wrist IVs, skin breakdown at the time of screening 6. Ankle site is not available, i.e. patients with leg ulcer at the time of screening 7. Lacking decision-making ability (such as from severe cognitive impairment) and no LAR available 8. Non-English speakers

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (5)

Lead Sponsor Collaborator
Duke University Hartford Foundation, National Institute on Aging (NIA), National Institutes of Health (NIH), T. Franklin Williams Scholars

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total number of minutes of activity (using objective accelerometer data). Length of hospital stay or up to 7 days during the patient's hospital stay.
Primary Total number of minutes of inactivity (using objective accelerometer data). Length of hospital stay or up to 7 days during the patient's hospital stay.
Secondary Total number of steps (using objective accelerometer data). Length of hospital stay or up to 7 days during the patient's hospital stay.
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