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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01030874
Other study ID # E7278-R
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2011
Est. completion date May 2016

Study information

Verified date June 2021
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

For patients recovering from acute illness, the ability to stand, walk, climb stairs, and participate in therapy are critical to their recovery and eventual discharge to the least restrictive environment. Orthostatic hypotension is a common finding in medically ill adult and elderly patients and is a potentially reversible contributor to functional impairment. This 4-year project will be a randomized controlled trial of a multidisciplinary-multicomponent intervention to determine whether routine identification and treatment of OH improves functional outcomes such as: balance, fall rates, therapy participation, length of stay, transfer to acute care hospital, and discharge location. Routine screening and management of OH may improve outcomes for rehabilitation and long term care patients, as well other high-risk patient populations.


Description:

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Study Design


Intervention

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Locations

Country Name City State
United States VA Portland Health Care System, Portland, OR Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Orthostatic Hypotension at Discharge Patients were categorized as having orthostatic hypotension at discharge if they had a decrease in systolic BP > 30 or diastolic pressure >15 mm Hg at 1 or 3 minutes after standing compared with the mean of the supine values, on two or more readings in the last week of admission. Duration in rehabilitation facility (time to discharge or transfer) varied for participants. For patients included in the analysis, mean length of stay was 41.2 days (median 31 days), with a range of 10 to 90 days.
Secondary Falls 30 Days After Discharge Falls 30 days after discharge was dichotomized to indicate whether a patient had at least one fall during the 30 days after discharge versus no falls. Time to discharge varied for participants. For patients included in the analysis, mean length of stay was 41.2 days (median 31 days), with a range of 10 to 90 days, so 30 days after discharge ranged from 40 days to 120 days.
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