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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02909231
Other study ID # REB15-1860
Secondary ID
Status Terminated
Phase N/A
First received September 19, 2016
Last updated December 5, 2017
Start date September 2016
Est. completion date December 5, 2017

Study information

Verified date December 2017
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the three, six, and twelve month patient reported outcomes of people admitted two trauma centres in western Canada over a four month period. Participants are evaluated using the Trauma Outcome Profile and a custom survey instrument.


Description:

This study intends to assess patient reported outcomes following discharge from trauma services at the Foothills Medical Centre (FMC) and Vancouver General Hospital (VGH). The investigators will survey participants with pen-and-paper surveys at three, six and twelve months following discharge from hospital. The survey instrument being used is the Trauma Outcomes Profile, which has been previously validated in this population, supplemented by a supplemental survey to help further describe resources this population has access to in their recovery. The results of these surveys will be compared with pre-injury health status, injury types, mechanisms, and discharge medications and treatments. The investigators anticipate enrolling 500 participants starting in October 2016. At the conclusion of the study the investigators will have a better understanding of patient reported functional outcomes after trauma and will be better positioned to design trauma rehabilitation systems to service this population.


Recruitment information / eligibility

Status Terminated
Enrollment 42
Est. completion date December 5, 2017
Est. primary completion date December 5, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- admitted to the trauma service at VGH or FMC

- Age 18 or older

- resident of Canada

Exclusion Criteria:

- English language literacy

- Impairments in cognition, motor, or communication that limit the ability to complete a paper-based survey

- No fixed address

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of Calgary University of British Columbia, Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medium-term health-related quality of life Assessment at 3, 6 and 12 months using the Trauma Outcomes Profile survey instrument. Up to one year
Secondary Local resource use for trauma patients admitted to hospital Assessment at 3, 6, and 12 months using a custom survey to assess local resource use and perceived needs Up to one year
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