NCT01801969

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
653

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

February 6, 2013

Last Update Submit

March 17, 2016

Conditions

Keywords

Brain injuriesRehabilitation servicesReturn to WorkQuality of life

Outcome Measures

Primary Outcomes (1)

  • time to return to work

    Data Source: Register (DREAM)

    up to 11 years post-injury

Secondary Outcomes (1)

  • Quality of life

    1-10 years post-injury

Study Arms (1)

Rehabilitation service

* Centralized or Decentralized rehabilitation * Size of municipality

Other: Rehabilitation service

Interventions

* 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

Rehabilitation service

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals suffering from severe TBI (GCS\<9) from the Danish Head Trauma Database

You may qualify if:

  • age 18-64

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammel Neurorehabilitation and Research Centre

Hammel, 8450, Denmark

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Lene Odgaard

    Research Unit (Forskningsenheden), Hammel Neurorehabilitation and Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

March 1, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2015

Study Completion

December 1, 2016

Last Updated

March 18, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations