Traumatic Brain InjuryBIIG-FACSNCT01062243
Brain Injury Inpatient Educational Intervention for Families and Caregivers
A study testing Brain Injury Education in people with Traumatic Brain Injury and Acquired Brain Injury, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute, inpatient brain injury rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Acquired Brain Injury
- What is being tested?
- Brain Injury Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family members/caregiver friends of patients with ABI will be eligible to participate in the present investigation. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, non-progressive brain tumor, infection, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture.
- Lacerations and/or bruises of the scalp or forehead without other criteria listed above will be excluded.
- All family member participants and patients must be at least 18 years of age or older and able to understand and provide consent (or assent in the case of the patients).
Who cannot join
- Family members at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298-0542
About this study
Official title: Brain Injury Inpatient Educational Intervention for Families and Caregivers (a Research Project Within the Traumatic Brain Injury Model System)
The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute, inpatient brain injury rehabilitation.
Read the detailed description
The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation. Program development was guided by considerable clinical experience, research review, and solicited consumer feedback.
The intervention has been manualized to facilitate efficient and effective administration. Now, a rigorous investigation involving randomized assignment to treatment and control groups is needed to empirically examine outcomes. Helping family members to cope more effectively has the potential to improve outcomes for persons with ABI. Strengthening families can enable persons with ABI to live more independently, achieve greater community integration, and live healthier lives. The investigation serves as a logical next step forward in advancing our understanding of standardized interventions designed to serve the family unit.
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury
- Being tested
- Brain Injury Education
- Keywords
- brain injury, family treatment
- 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.
Brain Injury EducationBehavioural
The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Brain Injury Education | Experimental | The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation. Receives: Behavioral: Brain Injury Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge gained from educational materials
Measured: Post-treatment and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Kreutzer, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062243
- Sponsor's protocol ID
- H133A070036
- Acronym
- BIIG-FACS
- Status last verified
- Jul 2013
- First submitted
- 29 Jan 2010
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Niemeier JP, Kreutzer JS, Marwitz JH, Sima AP. A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. Arch Phys Med Rehabil. 2019 Apr;100(4S):S65-S75. doi: 10.1016/j.apmr.2018.07.422. Epub 2018 Jul 31.
PubMed 30075147
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Injury Inpatient Educational Intervention for Families and Caregivers (a Research Project Within the Traumatic Brain Injury Model System)
- ClinicalTrials.gov ID
- NCT01062243
- Acronym / sponsor ID
- BIIG-FACS / H133A070036
- Conditions
- Traumatic Brain Injury, Acquired Brain Injury
- Keywords
- brain injury, family treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Feb 2010 (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 Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute, inpatient brain injury rehabilitation.
Detailed description
The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation. Program development was guided by considerable clinical experience, research review, and solicited consumer feedback.
The intervention has been manualized to facilitate efficient and effective administration. Now, a rigorous investigation involving randomized assignment to treatment and control groups is needed to empirically examine outcomes. Helping family members to cope more effectively has the potential to improve outcomes for persons with ABI. Strengthening families can enable persons with ABI to live more independently, achieve greater community integration, and live healthier lives. The investigation serves as a logical next step forward in advancing our understanding of standardized interventions designed to serve the family unit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Injury Education | Experimental | Behavioral: Brain Injury EducationThe Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Family members/caregiver friends of patients with ABI will be eligible to participate in the present investigation. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, non-progressive brain tumor, infection, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture.
- Lacerations and/or bruises of the scalp or forehead without other criteria listed above will be excluded.
- All family member participants and patients must be at least 18 years of age or older and able to understand and provide consent (or assent in the case of the patients).
Key exclusion criteria (1 listed)
- Family members at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
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 |
|---|---|---|
| Brain Injury EducationThe Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation. | Behavioural | Brain Injury Education |
Primary outcome
Knowledge gained from educational materials
Time frame: Post-treatment and 3 month follow-up
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 31 Jul 2013.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 30075147Niemeier JP, Kreutzer JS, Marwitz JH, Sima AP. A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. Arch Phys Med Rehabil. 2019 Apr;100(4S):S65-S75. doi: 10.1016/j.apmr.2018.07.422. Epub 2018 Jul 31.
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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.
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?
A study testing Brain Injury Education in people with Traumatic Brain Injury and Acquired 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 3 inclusion and 1 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 31 Jul 2013. 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.
What does the primary outcome measure?
Knowledge gained from educational materials (time frame: Post-treatment and 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01062243, which also lists 2 linked publications.
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 31 Jul 2013.