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Brain Injury Inpatient Educational Intervention for Families and Caregivers (BIIG-FACS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01062243
First Posted: February 4, 2010
Last Update Posted: July 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
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.

Condition Intervention
Traumatic Brain Injury Acquired Brain Injury Behavioral: Brain Injury Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Brain Injury Inpatient Educational Intervention for Families and Caregivers (a Research Project Within the Traumatic Brain Injury Model System)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Knowledge gained from educational materials [ Time Frame: Post-treatment and 3 month follow-up ]

Enrollment: 110
Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brain Injury Education
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.
Behavioral: Brain Injury Education
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062243


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0542
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Jeffrey S Kreutzer, PhD Virginia Commonwealth University
  More Information

Additional Information:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01062243     History of Changes
Other Study ID Numbers: H133A070036
First Submitted: January 29, 2010
First Posted: February 4, 2010
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Virginia Commonwealth University:
brain injury
family treatment

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System