AmnesiaNCT00476528
Early Rehabilitation of Patients With Posttraumatic Amnesia
A study testing Reality Orientation in people with Amnesia, run by University of Aarhus at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amnesia
- What is being tested?
- Reality Orientation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2007to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should be able to speak and understand danish
- Patients with traumatic brain injury
- A verified brain injury at the CT scanning
Who cannot join
- Patients with medical illness
- Patients with other neurological illness
- Patients with neuroinfections meningitic, encephalitic
- Patients who does not understand and speaks danish
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Amnesia
- Being tested
- Reality Orientation
- Keywords
- Posttraumatic amnesia, Early intervention, A systematic nursing programme in the ICU, Early identification of patients with posttraumatic amnesia
- Medical subject headings
- Amnesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reality OrientationBehavioural
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.
Reality OrientationBehavioural
A quasiexperimental study
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2009 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmnesiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jens Christian Soerensen, Study director, Department of Neurosurgery NK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476528
- Sponsor's protocol ID
- NK8633
- Status last verified
- Aug 2010
- First submitted
- 21 May 2007
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00476528
- Acronym / sponsor ID
- NK8633
- Conditions
- Amnesia
- Keywords
- Posttraumatic amnesia, Early intervention, A systematic nursing programme in the ICU, Early identification of patients with posttraumatic amnesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients should be able to speak and understand danish
- Patients with traumatic brain injury
- A verified brain injury at the CT scanning
Key exclusion criteria (4 listed)
- Patients with medical illness
- Patients with other neurological illness
- Patients with neuroinfections meningitic, encephalitic
- Patients who does not understand and speaks danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reality OrientationTwo 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. | Behavioural | – |
| Reality OrientationA quasiexperimental study | Behavioural | – |
Primary outcome
Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS
Time frame: 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Christian Soerensen study director
Department of Neurosurgery NK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reality Orientation in people with Amnesia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS (time frame: 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.