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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT01062243
Collaborator
(none)
110
1
1
38
2.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brain Injury Education
N/A

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

Study Type:
Interventional
Actual Enrollment :
110 participants
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)
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Knowledge gained from educational materials [Post-treatment and 3 month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01062243
Other Study ID Numbers:
  • H133A070036
First Posted:
Feb 4, 2010
Last Update Posted:
Jul 31, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Virginia Commonwealth University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 31, 2013