Back to resultsEarly Rehabilitation of Patients With Posttraumatic Amnesia
Primary Purpose
Amnesia
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Reality Orientation
Reality Orientation
Sponsored by
About this trial
This is an interventional supportive care trial for Amnesia focused on measuring Posttraumatic amnesia, Early intervention, A systematic nursing programme in the ICU, Early identification of patients with posttraumatic amnesia
Eligibility Criteria
Inclusion Criteria:
- Patients should be able to speak and understand danish
- Patients with traumatic brain injury
- A verified brain injury at the CT scanning
Exclusion Criteria:
- Patients with medical illness
- Patients with other neurological illness
- Patients with neuroinfections meningitic, encephalitic
- Patients who does not understand and speaks danish
Sites / Locations
- University Hospital
Outcomes
Primary Outcome Measures
Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00476528
Brief Title
Early Rehabilitation of Patients With Posttraumatic Amnesia
Official Title
Early Rehabilitation of Patients With Posttraumatic Amnesia. A Clinical Controlled Investigation of the Effect of a Nursing Programme in Patients With Traumatic Brain Injury in the Acute Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
A systematic review with the latest investigation and treatment of patients with posttraumatic amnesia
Investigate the effect of a systematic nursing programme on the length of posttraumatic amnesia
Investigate the effect of a systematic nursing programme after 12 month
Describe perspectives for the future within the early rehabilitation of patients with posttraumatic amnesia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amnesia
Keywords
Posttraumatic amnesia, Early intervention, A systematic nursing programme in the ICU, Early identification of patients with posttraumatic amnesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Reality Orientation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reality Orientation
Intervention Description
A quasiexperimental study
Primary Outcome Measure Information:
Title
Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS
Time Frame
12month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients should be able to speak and understand danish
Patients with traumatic brain injury
A verified brain injury at the CT scanning
Exclusion Criteria:
Patients with medical illness
Patients with other neurological illness
Patients with neuroinfections meningitic, encephalitic
Patients who does not understand and speaks danish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Christian Soerensen
Organizational Affiliation
Department of Neurosurgery NK
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital
City
Aarhus
State/Province
Region Midtjylland
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Early Rehabilitation of Patients With Posttraumatic Amnesia
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