- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917694
A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma
A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes of Major Trauma Patients Admitted to an Intensive Care Unit, Using the WHO DAS 2.0.
Study Overview
Status
Conditions
Detailed Description
Currently there is no standardised way of obtaining details about a patients pre-admission level of function. the process of gaining this history is often done by several different people with no standard questions asked.
There is also a need to be able to measure what happens to patients after they leave ICU, and compare their abilities to preadmission status.
This feasibility study will aim to investigate:
- the time taken to train the physiotherapy team in the use of the outcome measure
- the ability to obtain pre admission functional status from patients/friend/relative on admission to ICU
- the ability to follow patients up at 6 months post discharge with re-assessment of the outcome measure
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oxford, United Kingdom, OX3 9DU
- John Radcliffe Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study
- Participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent)
- Male or Female, aged 18 years or above
- Injury Severity Score greater than 9
- Admitted as an emergency to AICU
- Experienced at least 24 hours level three care during their admission
Exclusion Criteria:
- Non UK resident (due to potential loss to follow up)
- Unwilling to consent
- No GP details available
- Patients with a palliative diagnosis or established on a palliative treatment pathway
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WHODAS 2.0 completion rate
Time Frame: 2 days
|
Number of questionnaires completed/returned on admission to ICU
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2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to questionnaire completion rate
Time Frame: 2 days
|
The time taken (hours) from ICU admission to complete the questionnaire
|
2 days
|
|
WHODAS 2.0 completion rate
Time Frame: 6 months post ICU discharge
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Number of questionnaires completed/returned at 6 months post ICU discharge
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6 months post ICU discharge
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Collaborators and Investigators
Investigators
- Principal Investigator: Rebekah Haylett, BSc (Hons), Oxfod University Hospitals NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 209899
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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