Traumatic Brain InjuryNCT00205569
Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation
An observational study of Traumatic Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
To learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- First Steps Educational Curriculum
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Oct 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with traumatic brain injury requiring inpatient rehabilitation and admitted to Virginia Commonwealth University's Medical College of Virginia Hospitals acutely after injury.
Who may be able to join
- adults (18 years or older) who have experienced a TBI (damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia, or skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination).
Who cannot join
- imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others.
- unable to tolerate treatment sessions due to physical, cognitive, behavioral, or other difficulties.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)
To learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury.
Read the detailed description
To evaluate the efficacy of the First Steps intervention for improving neurobehavioral functioning, functional status, and life satisfaction, and for increasing knowledge about TBI and compensatory strategies. The First Steps program was developed to address the neurobehavioral and emotional concerns of survivors of TBI during the course of inpatient rehabilitation. Program format and content reflects clinical experience and extensive research review. Input from survivors, family members, and rehabilitation staff trained in working with the TBI population has also helped shape the implementation protocol. The foundation of the protocol is a curriculum [Niemeier, J., Kreutzer, J., \& Taylor, L. (2005). Acute cognitive and neurobehavioral intervention for individuals with acquired brain injury: Preliminary outcome data. Neuropsychological Rehabilitation, 15(2), 129-146.] The First Steps curriculum consists of ten lessons and was developed to address the common needs, issues, and concerns of TBI survivors admitted acutely for inpatient rehabilitation.
- Conditions
- Traumatic Brain Injury
- Being tested
- First Steps Educational Curriculum
- Keywords
- brain injury, acute rehabilitation
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Steps Educational CurriculumBehavioural
10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals with traumatic brain injury requiring inpatient rehabilitation. Receives: Behavioral: First Steps Educational Curriculum |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Kreutzer, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205569
- Sponsor's protocol ID
- H133A02051603
- Other IDs
- H133A020516
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Niemeier JP, Kreutzer JS, Taylor LA. Acute cognitive and neurobehavioural intervention for individuals with acquired brain injury: preliminary outcome data. Neuropsychol Rehabil. 2005 May;15(2):129-46. doi: 10.1080/09602010443000083.
PubMed 16353506
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation (a Research Project Within the Traumatic Brain Injury Model System Grant)
- ClinicalTrials.gov ID
- NCT00205569
- Acronym / sponsor ID
- H133A02051603
- Conditions
- Traumatic Brain Injury
- Keywords
- brain injury, acute rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Oct 2002
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Sep 2005 (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.
To learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury.
Detailed description
To evaluate the efficacy of the First Steps intervention for improving neurobehavioral functioning, functional status, and life satisfaction, and for increasing knowledge about TBI and compensatory strategies. The First Steps program was developed to address the neurobehavioral and emotional concerns of survivors of TBI during the course of inpatient rehabilitation. Program format and content reflects clinical experience and extensive research review. Input from survivors, family members, and rehabilitation staff trained in working with the TBI population has also helped shape the implementation protocol. The foundation of the protocol is a curriculum [Niemeier, J., Kreutzer, J., \& Taylor, L. (2005). Acute cognitive and neurobehavioral intervention for individuals with acquired brain injury: Preliminary outcome data. Neuropsychological Rehabilitation, 15(2), 129-146.] The First Steps curriculum consists of ten lessons and was developed to address the common needs, issues, and concerns of TBI survivors admitted acutely for inpatient rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: First Steps Educational CurriculumIndividuals with traumatic brain injury requiring inpatient rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with traumatic brain injury requiring inpatient rehabilitation and admitted to Virginia Commonwealth University's Medical College of Virginia Hospitals acutely after injury.
Key inclusion criteria (1 listed)
- adults (18 years or older) who have experienced a TBI (damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia, or skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination).
Key exclusion criteria (2 listed)
- imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others.
- unable to tolerate treatment sessions due to physical, cognitive, behavioral, or other difficulties.
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 |
|---|---|---|
| First Steps Educational Curriculum10 sessions with the research participant to review an educational curriculum regarding brain injury rehabilitation and community reintegration | Behavioural | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Results publication: PubMed 16353506Niemeier JP, Kreutzer JS, Taylor LA. Acute cognitive and neurobehavioural intervention for individuals with acquired brain injury: preliminary outcome data. Neuropsychol Rehabil. 2005 May;15(2):129-46. doi: 10.1080/09602010443000083.
Related trials for Traumatic Brain Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries
Not yet recruiting
Implementation Study on Hospital-to-home Advanced Rehabilitation Technologies (ART)
Brain Injuries
RecruitingObservational study
Cortical Spreading Depolarization After Severe Traumatic Brain Injury
Traumatic Brain Injury
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.
Jeffrey S Kreutzer, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 17 Mar 2017. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00205569, which also lists 1 linked publication.
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 17 Mar 2017.