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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01801969
Other study ID # hovedtraume
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 6, 2013
Last updated March 17, 2016
Start date February 2013
Est. completion date December 2016

Study information

Verified date March 2016
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: National Board of Health
Study type Observational

Clinical Trial Summary

The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services.

In Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities

The first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life.

The second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI.

Data on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire.

The study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 653
Est. completion date December 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- age 18-64

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Rehabilitation service
Centralized/ decentralized hospital based rehabilitation defined as hospital based rehabilitation in a single or in multiple locations, respectively. Size of the municipality responsible for providing rehabilitation services after discharge from hospital

Locations

Country Name City State
Denmark Hammel Neurorehabilitation and Research Centre Hammel

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to return to work Data Source: Register (DREAM) up to 11 years post-injury No
Secondary Quality of life Data Source: Questionnaire (QUOLIBRI) 1-10 years post-injury No
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