NCT00476528

Brief Summary

The purpose of this study is to investigate if a systematic intervention with early identifying of patients with posttraumatic amnesia using a reality orientation therapy can reduce the period with posttraumatic amnesia in order to get a better outcome for patients with traumatic brain injury

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
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 10, 2010

Status Verified

August 1, 2010

Enrollment Period

2 years

First QC Date

May 21, 2007

Last Update Submit

August 9, 2010

Conditions

Amnesia

Keywords

Posttraumatic amnesiaEarly interventionA systematic nursing programme in the ICUEarly identification of patients with posttraumatic amnesia

Outcome Measures

Primary Outcomes (1)

  • Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS

    12month

Interventions

Reality OrientationBEHAVIORAL

Two matched groups of patients diagnosed with TBI are selected from two university hospitals. In addition to conventional treatment, patients in one group are introduced to a reality- orientation programme consisting of systematic orientation, information, and systematic cooperation with the patient´s relatives.Patients in the other group receive conventional treatment only. All patients are tested on a daily basis in accordance with the RLAS and the GOAT test.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should be able to speak and understand danish
  • Patients with traumatic brain injury
  • A verified brain injury at the CT scanning

You may not qualify if:

  • Patients with medical illness
  • Patients with other neurological illness
  • Patients with neuroinfections meningitic, encephalitic
  • Patients who does not understand and speaks danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Aarhus, Central Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Amnesia

Condition Hierarchy (Ancestors)

Memory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Jens Christian Soerensen

    Department of Neurosurgery NK

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

August 10, 2010

Record last verified: 2010-08

Locations

DK(1)