NCT00419939

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

4.3 years

First QC Date

January 8, 2007

Last Update Submit

June 20, 2011

Conditions

Keywords

Severe traumatic brain injuryIntensive neurorehabilitation"Patient Participation"[Professional-Patient Relations"Re-learningDaily life activitiesRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Improvement of the patients experience of meaningful learning and influence

    4 -8 weeks

Secondary Outcomes (1)

  • 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

    4 - 8 weeks

Study Arms (1)

1

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Hospital Hammel Neurorehabilitation Centre

Voldbyvej 15, Hammel, 8450, Denmark

Location

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Karsten Koch-Jensen, Head of c

    Regionshospitalet Hammel Neurocenter

    STUDY DIRECTOR
  • Marit Kirkevold, Professor

    Department of nursing science, Aarhus University

    STUDY CHAIR
  • Lena Aadal, Ph.d stud.

    Regionshospitalet Hammel Neurocenter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2007

First Posted

January 9, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 21, 2011

Record last verified: 2011-06

Locations