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

• Sponsor: University of Aarhus (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01801969
• Collaborator: (none)
• Enrollment: 653
• Location: 1
• Duration (Months): 46
• Patients Per Site Per Month: 14.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries; Return to Work; Quality of Life	Other: Rehabilitation service

Study Design

• Study Type: Observational
• Actual Enrollment: 653 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Return to Work and QOL Following TBI. Impact of Rehabilitation Service.
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Rehabilitation service Centralized or Decentralized rehabilitation Size of municipality	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

Outcome Measures

Primary Outcome Measures

1. time to return to work [up to 11 years post-injury]

   Data Source: Register (DREAM)

Secondary Outcome Measures

1. Quality of life [1-10 years post-injury]

   Data Source: Questionnaire (QUOLIBRI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18-64

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammel Neurorehabilitation and Research Centre	Hammel		Denmark	8450

Sponsors and Collaborators

• University of Aarhus

Investigators

• Principal Investigator: Lene Odgaard, Research Unit (Forskningsenheden), Hammel Neurorehabilitation and Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01801969
• Other Study ID Numbers: hovedtraume
• First Posted: Mar 1, 2013
• Last Update Posted: Mar 18, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Aarhus: Brain injuries; Rehabilitation services; Return to Work; Quality of life
• Additional relevant MeSH terms: Brain Injuries

Study Results

No Results Posted as of Mar 18, 2016