Return to Work and QOL Following TBI. Impact of Rehabilitation Service.

Quality of Life Clinical Trial

Official title:

Return to Work and QOL Following TBI. Impact of Rehabilitation Service.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01801969
• Other study ID #: hovedtraume
• 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

• Brain Injuries
• Quality of Life
• Return to Work

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