Intensive Rehabilitation of Patients With Severe Traumatic Brain Injury - Development of a Didactic Model

This study has been completed.

Sponsor:

Collaborator:

Regionshospitalet Hammel Neurocenter

Information provided by:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT00419939

First received: January 8, 2007

Last updated: June 20, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2007

Last Updated Date

June 20, 2011

Start Date ^ICMJE

February 2007

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement of the patients experience of meaningful learning and influence [ Time Frame: 4 -8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00419939 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Provide staff with a tool which contributes to the experience to work in a targeted way concerning motivation, patient influence and re-learning daily life competencies [ Time Frame: 4 - 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intensive Rehabilitation of Patients With Severe Traumatic Brain Injury - Development of a Didactic Model

Official Title ^ICMJE

Improvement of the Interaction Between Motivation, Involvement and Re-learning of Daily Life Competences During the Intensive Neurorehabilitation of Patients With Severe TBI. Development of a Research-based Didactic Model.

Brief Summary

The aim of the study is to develop a research-based pedagogic model to improve the interaction between the patient`s motivation, influence and learning.The hypothesis is:

A neuro-rehabilitation effort in patients with severe traumatic brain injury based on a didactic model for improvement of motivation, involvement and re-learning of daily life competences will

improve the patients experience of meaningful learning and influence
provide staff with a tool which contributes to the experience to work in a targeted way concerning motivation, patient influence and re-learning daily life competencies

The aim of the study is to develop a research-based didactic model to improve the interaction between the patient`s motivation, influence and learning.

Detailed Description

Annually, about 7500 people get a traumatic brain injury (TBI) in Denmark. According to Danish and international experiences 250 of these get severe injuries. About 120 younger people often males need highly specialised neuro-rehabilitation at one of the two regional centres in Denmark. Due to the limited amount of research in this field it cannot be documented but assumed, that the patient's motivation and involvement in planning and implementation of rehabilitation improve subjective and objective outcome. Motivation, involvement and learning in patients with severe traumatic brain injury constitute a major challenge. The cases are individual, but often involve disturbances in language and perception, lack of realization, reduced initiative, tiredness and depression. The focus of this project is the intensive physical and psychosocial rehabilitation viewed as a process of relearning targeted daily life competences using the ICF levels of function, activity and participation.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

ab 10 patientsr with acquired severe brain injury (GCS 3 - 9), >18 år, PTA phase at the end (GOAT scoring), RLAS score at minimum 4 and informed consent in writing

Condition ^ICMJE

Craniocerebral Trauma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

ab 10 patientsr with acquired severe brain injury (GCS 3 - 9), >18 år, PTA phase at the end (GOAT scoring), RLAS score at minimum 4 and informed consent in writing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Severe traumatic brain injury (GCS 3-9)
Older than 18 years
Post Traumatic Amnesiphase (PTA) at the end, 4 Ranchos Los Amigos (RLAS) score at minimum 4
Informed consent

Exclusion Criteria:

Younger than 18 years
In PTA phase
RLAS score lower than 4
No informed consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00419939

Other Study ID Numbers ^ICMJE

2007-RHN-01

Has Data Monitoring Committee

Responsible Party

Jørgen Feldbæk Nielsen, Hammel Neurocenter

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Regionshospitalet Hammel Neurocenter

Investigators ^ICMJE

Study Director:	Karsten Koch-Jensen, Head of c	Regionshospitalet Hammel Neurocenter
Study Chair:	Marit Kirkevold, Professor	Department of nursing science, Aarhus University
Principal Investigator:	Lena Aadal, Ph.d stud.	Regionshospitalet Hammel Neurocenter

Information Provided By

University of Aarhus

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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